Colorectal Disease - AECP

Colorectal Disease

Volume 19 Supplement 3 September 2017

Pelvic Floor Soc / ACPGBI / ESCP Graded Practice Recommendations on Chronic

Constipation

Contents

1. Editorial Surgery for constipation: systematic review and clinical guidance 3–4

2. Surgery for constipation: systematic review and clinical guidance Paper 1: Introduction & Methods 5–16

3. Surgery for constipation: systematic review and practice recommendations Results I: Colonic resection 17–36

4. Surgery for constipation: systematic review and practice recommendations Results II: Hitching procedures for the rectum (rectal suspension) 37–48

5. Surgery for constipation: systematic review and practice recommendations Results III: Rectal wall excisional procedures (Rectal Excision) 49–72

6. Surgery for constipation: systematic review and practice recommendations Results IV: Recto-vaginal reinforcement procedures 73–91

7. Surgery for constipation: systematic review and practice recommendations Results V: Sacral Nerve Stimulation 92–100

8. Surgery for constipation: systematic review and practice recommendations Graded practice and future research recommendations 101–113

Surgery for constipation: systematic review and clinicalguidance

The surgical treatment of functional and pelvic floor dis-

orders has often been a “Cinderella” subject, both in

terms of the health care and academic agendas. Histori-

cally this status may have been in part be due to the com-

plexities of the treatment of such conditions, due to their

multidisciplinary nature, cutting across three main surgi-

cal specialties (coloproctology, urology & gynaecology),

as well as necessitating input from colleagues in medical,

nursing, physiotherapy, radiology and clinical physiology

specialties. It does, however, in no way reflect the preva-

lence of the disorders or their burden on both the indi-

vidual or society as a whole. Not surprisingly this

problem has led to wide variation in clinical practice and a

degree of uncertainty among those who fund or reim-

burse healthcare as to exactly what constitutes acceptable

evidence based surgical care, resulting in some declining

to fund some treatments at all. As multidisciplinary work-

ing has become the norm within modern health care sys-

tems, its application to functional and pelvic floor

disorders has changed resource provision and led to a

renewed interest in their aetiology and treatment strate-

gies resulting in a profound transformation of academic

endeavour in the field.

The two decades since Horton’s polemic editorial

regarding the “comic opera” of surgical research [1], has

generated a focus on the performance and publication of

the gold standard of intervention assessment, the ran-

domised controlled trial. More complex to perform in

the setting of surgery, compared with pharmaceutical

studies for example, the past decade alone has seen several

high quality multicentre studies investigating surgical

interventions within the field of functional and pelvic

floor disorders, but mainly related to faecal incontinence

and rectal prolapse [2–5]. Despite the high prevalence

and demand on health care resources, surgical treatments

for chronic constipation have not received the same in-

depth assessment, with placebo controlled trials of novel

pharmaceutical agents predominating.

The UK National Institute for Health Research

(NIHR) have funded the investigation of three types of

non-drug therapies for chronic constipation (bowel

retraining, anal irrigation & laparoscopic ventral mesh

rectopexy for internal rectal prolapse - see www.blizard.

qmul.ac.uk/capacity.html). As a prelude to these well

designed but complex studies, the CapaCiTY Working

Group, along with a broad consensus group derived

from the ACPGBI affiliated Pelvic Floor Society and

ESCP have seized the opportunity to assess the litera-

ture available on the surgical treatment of chronic

constipation. The aim has clearly been to try and make

sense of a confusing array of procedures described

across a plethora of manuscripts and to provide a rigor-

ous assessment of the quality of the currently available

literature. In addition, the team have endeavoured to

make a series of graded practice recommendations in

order to facilitate the often challenging decision making

relating to the care of such patients. The intention is

help optimise patient outcome, minimise harm and

reduce unjustifiable variation in practice. Unfortunately,

there is no similar national body in the USA although

the American Society of Colon and Rectal Surgeons

publishes practice parameters on a variety of topics.

This series of seven papers collates for the first time the

evidence for five key areas of surgical practice relating to

the treatment of chronic constipation: colonic resection,

rectal suspension, rectal wall excision, reinforcement of the

rectovaginal septum and sacral nerve stimulation. The series

starts with an introductory paper that gives a detailed over-

view of the general methods used, search results and study

characteristics. Subsequently, each of the five areas of surgi-

cal practice has its own detailed systematic review (and

where appropriate meta-analysis) with summary evidence

statements. The final paper is a synopsis of graded practice

recommendations and crucially, recommendations for

future research. Here the authors have been open and shar-

ing suggestions for alternative appropriate study designs

when randomised trials are unfeasible. For some of the

more uncommon procedures multicentre international col-

laborative prospective cohort studies using the paradigms

exemplified in previous ESCP studies may be more infor-

mative [6]. We endorse the authors recommendations of

appropriate outcomes reporting via core outcome data sets

(http://www.comet-initiative.org/) and that the evalua-

tion of future innovations should adhere to the principles

of the IDEAL collaboration (http://www.ideal-collabora

tion.net/). There remains, however, the issue of health

economic impact and what treatments will ultimately be

funded. All healthcare systems face financial challenges and

increasingly cost effectiveness is important in the decision-

making process for healthcare funders. There remains

much to be investigated and little work has, as yet, been

directed at the assessment of surgical interventions in this

context. Determining and delivering a high quality research

agenda that answers the needs of patients, healthcare provi-

ders and healthcare funder alike will be welcomed by all.

The focus on quality of surgical outcome, procedural

safety and patient reported outcomes in this series of seven

papers is to be commended. The quotidian dilemmas

ª 2017 The Authors. Colorectal Disease published by John Wiley & Sons Ltd

on behalf of Association of Coloproctology of Great Britain and Ireland. 19 (Suppl. 3), 3–4 3

This is an open access article under the terms of the Creative Commons Attribution License, which permits use,

distribution and reproduction in any medium, provided the original work is properly cited.

Editorial doi:10.1111/codi.13809

http://www.blizard.qmul.ac.uk/capacity.html

http://www.blizard.qmul.ac.uk/capacity.html

http://www.comet-initiative.org/

http://www.ideal-collaboration.net/

http://www.ideal-collaboration.net/

http://creativecommons.org/licenses/by/4.0/

within coloproctology practice have been expertly sum-

marised and sensible recommendations with reasonable

consensus made. We would encourage their widespread

use by multidisciplinary teams in the formation of their

treatment pathways / algorithms. There remain, however,

some questions that have not been addressed because they

are beyond the scope of such a clearly defined review topic

and they relate to the more global management controver-

sies that pervade and area of our specialty that can be both

simultaneously rewarding and frustrating.

Many of the studies included in this series of manu-

scripts highlight the issue of complex interventions having

favourable outcomes in patients who are often

euphemistically described as being “carefully selected”.

This nebulous term rarely relates to judiciously described

preoperative evaluation protocols and results defined a

priori that mandate consideration of certain operative

interventions. How should such patients be investigated

when debate remains regarding the interpretation of some

investigations such as defaecating proctography [7] and

the expense of others (e.g. wireless motility capsule)

severely limits widespread dissemination [8]?

While non-operative management strategies form the

mainstay of therapy, by what criteria should patients

progress through increasingly invasive treatment

options? The association of functional gastrointestinal

and pelvic floor disorders with psychological diagnoses

is increasingly recognised and the influence on treat-

ment outcomes being defined [9]. How psychological

factors are accounted for in the decision to progress

through step wise pathways of care that ultimately lead

to operative intervention in many of the reported series

is opaque and yet may have a profound impact on the

consultation between patient and surgeon. It is reassur-

ing to note that in this series of papers the consensus

was towards mandating psychological evaluation in all

those considering colectomy and should only be per-

formed in centres with access to appropriate specialist

services.

Finally, what is the course of action when catastrophe

strikes? The operations described within this series,

including colectomy and ileorectal anastomosis, STARR,

ventral mesh rectopexy and others all have something to

offer the right patient with the right pathology when

appropriately counselled and operated upon by the right

surgeon. Despite optimal circumstances each of these

operations is associated with some of the most devastating

complications, including anastomotic leak, rectovaginal

fistulae, intractable pelvic pain and worse. They are thank-

fully rare but do occur and how these situations should be

managed needs clarifying. In such circumstances the role

of a stoma as an active positive choice, rather than being a

sign of failure, should be considered.

The heuristics used by surgeons when evaluating

what interventions to offer patients with functional gas-

trointestinal and pelvic floor disorders have not been

studied, unlike in rectal cancer patients. It may be that

the perceived risk benefit ratio in a benign disease

(where propensity for risk-taking tends to be lower) has

had a negative impact on the utilisation of some opera-

tions (e.g. STARR, TranSTARR) when on a prima facie

basis, the evidence may point to benefit. Surgeons may

not be the most evidence based practitioners within the

broader medical fraternity, but they are rarely abject

fools. The core principle of the management of patients

with these conditions remains primum non nocere.

Hopefully, the impressive authoritative comprehensive

compendium published by Professor Knowles and his

colleagues will help us achieve that goal.

Neil J Smart* and Steven Wexner†*Royal Devon & Exeter Hospital & Honorary Senior Lecturer, University of

Exeter Medical School, Exeter, UK and †Digestive Disease Center, Depart-ment of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida, USA

References

1 Horton R. Surgical research or comic opera: questions, but

few answers. Lancet 1996; 347: 984–5.

2 Knowles CH, Horrocks EJ, Bremner SA et al., CONFI-

DeNT study group. Percutaneous tibial nerve stimulation

versus sham electrical stimulation for the treatment of faecal

incontinence in adults (CONFIDeNT): a double-blind, mul-

ticentre, pragmatic, parallel-group, randomised controlled

trial. Lancet 2015; 386: 1640–8.

3 Graf W, Mellgren A, Matzel KE, Hull T, Johansson C,

Bernstein M, NASHA Dx Study Group. Efficacy of dextra-

nomer in stabilised hyaluronic acid for treatment of faecal

incontinence: a randomised, sham-controlled trial. Lancet

2011; 377: 997–1003.

4 Morris OJ, Smith S, Draganic B. Comparison of bulking

agents in the treatment of fecal incontinence: a prospective

randomized clinical trial. Tech Coloproctol 2013; 17: 517–23.

5 Senapati A, Gray RG, Middleton LJ et al. PROSPER: a ran-

domised comparison of surgical treatments for rectal pro-

lapse. Colorectal Dis 2013 Jul; 15: 858–68.

6 2015 European Society of Coloproctology collaborating

group. The relationship between method of anastomosis and

anastomotic failure after right hemicolectomy and ileo-caecal

resection: an international snapshot audit. Colorectal Dis

2017, https://doi.org/10.1111/codi.13646.

7 Palit S, Bhan C, Lunniss PJ et al. Evacuation proctography: a rea-

ppraisal of normal variability. Colorectal Dis 2014; 16: 538–46.

8 Rao SS, Meduri K. What is necessary to diagnose constipa-

tion? Best Pract Res Clin Gastroenterol 2011; 25: 127–40.

9 Nehra V, Bruce BK, Rath-Harvey DM, Pemberton JH,

Camilleri M. Psychological disorders in patients with evacua-

tion disorders and constipation in a tertiary practice. Am J

Gastroenterol 2000; 95: 1755–8.


on behalf of Association of Coloproctology of Great Britain and Ireland. 19 (Suppl. 3), 3–44

Editorial

http://orcid.org/0000-0002-3043-8324

http://orcid.org/0000-0002-3043-8324

http://orcid.org/0000-0002-3043-8324

https://doi.org/10.1111/codi.13646

Surgery for constipation: systematic review and clinicalguidance

Paper 1: Introduction & Methods

C. H. Knowles*, U. Grossi*, E. J. Horrocks*, D. Pares†, P. F. Vollebregt*, M. Chapman‡,S. R. Brown§, M. Mercer-Jones¶, A. B. Williams**, R. J. Hooper††, N. Stevens††, J. Mason‡‡,on behalf of the NIHR CapaCiTY working group§§ and The Pelvic floor Society¶¶*National Bowel Research Centre, Blizard Institute, Queen Mary University London, London, UK, †Hospital Germans Tr�ıas i Pujol, Barcelona, Spain,

‡Good Hope Hospital, Heart of England NHS Trust, Birmingham, UK, §Sheffield Teaching Hospitals, Sheffield, UK, ¶Queen Elizabeth Hospital,

Gateshead NHS Trust, Gateshead, UK, **Guy’s and St Thomas’ NHS Foundation Trust, London, UK, ††Pragmatic Clinical Trials Unit, Blizard Institute,

Queen Mary University of London, London, UK, ‡‡University of Warwick, Coventry, UK, §§National Institute for Health Research: Chronic

Constipation Treatment Pathway, UK, and ¶¶Affiliate section of the Association of Coloproctology of Great Britain and Ireland, London, UK

Abstract

Aim This manuscript provides the introduction and

detailed methodology used in subsequent reviews to

assess the outcomes of surgical interventions with the

primary intent of treating chronic constipation in adults

and to develop recommendations for practice.

Method PRISMA guidance was adhered to throughout.

A literature search was performed in public databases

between January 1960 and February 2016. Studies that

fulfilled strictly-defined PICOS (patients, interventions,

controls, outcome, and study design) criteria were

included. The process involved two groups of partici-

pants: (i): ‘a clinical guidance group’ of 18 UK experts

(including junior support) who performed the system-

atic reviews and produced summary evidence statements

(SES) based strictly on data synthesis in each review.

The same group then produced prototype graded prac-

tice recommendations (GPRs) based on coalescence of

SES and expert opinion; (ii): a European Consensus

group of 18 ESCP (European Society of Coloproctol-

ogy) nominated experts from nine European countries

evaluated the appropriateness of each prototype GPR

based on published RAND/UCLA methodology.

Results An overview of the search results is provided in

this manuscript. A total of 156 studies from 307 full

text articles (from 2551 initially screened records) were

included, providing data on procedures characterized

by: (i) colonic resection (n = 40); (ii) rectal suspension

(n = 18); (iii) rectal wall excision (n = 44); (iv) recto-

vaginal septum reinforcement (n = 47); (v) sacral nerve

stimulation (n = 7). The overall quality of evidence was

poor with 113/156 (72.4%) studies providing only

Oxford level IV evidence. The best evidence was

extracted for rectal excisional procedures, where the

majority of studies were Oxford level I or II. The five

subsequent reviews provide a total of 99 SES (reflecting

perioperative variables, efficacy, harms and prognostic

variables) that contributed to 100 prototype GPRs cov-

ering patient selection, procedural considerations and

patient counselling. The final manuscript details the

85/100 GPRs that were deemed appropriate by Euro-

pean Consensus (remaining 15 were all uncertain) and

future research recommendations.

Conclusion This manuscript and the following 6 papers

suggest that the evidence base for surgical management

of chronic constipation is currently poor although some

expert consensus exists on best practice. Further studies

are required to inform future commissioning of treat-

ments and of research funding.

Keywords Constipation, surgery, obstructed defaecation

Introduction

Constipation is common in adults and children with up

to 20% of the population reporting symptoms

depending on the definition used (2–28% adults; 0.7–30% children) [1–3]. Chronic constipation (CC), usu-

ally defined as more than 6 months of symptoms, is less

common but results in 0.5 million UK GP consulta-

tions per annum. A proportion of the population suffer

symptoms that are both chronic and more disabling

(probably about 0.4% population) [4]. Such patients,

Correspondence to: Prof. Charles H. Knowles, NBRC, 1st Floor Abernethy

Building, 2 Newark St, London E1 2AT, UK.

E-mail: [email protected]





Systematic review doi:10.1111/codi.13774


who are predominantly female [5], are usually referred

to secondary care with many progressing to tertiary spe-

cialist investigation. Patient dissatisfaction is high in this

group; nearly 80% feel that laxative therapy is unsatisfac-

tory [6] and the effect of symptoms on measured QOL

is significant [7]. CC consumes significant healthcare

resources. In the US in 2012, a primary complaint of

constipation was responsible for 3.2 million physician

visits resulting in (direct and indirect) costs of $1.7 bil-

lion [8]. In the UK, it is estimated 10% of district nurs-

ing time is spent on bowel control [9] and the annual

spend on laxatives exceeds £117 m, with 18.3 million

prescriptions in 2014 of which 91% were for stimulant

and osmotic laxatives (Health and Social Care Informa-

tion Centre) [10].

The act of defaecation is dependent on the coordi-

nated functions of the colon, rectum and anus. Consid-

ering the complexity of neuromuscular (sensory and

motor) functions required to achieve planned, con-

scious, and effective defaecation [11], it is no surprise

that disturbances to perceived ‘normal’ function occur

commonly at all stages of life. Clinically, such problems

commonly lead to symptoms of obstructed defaecation

e.g. straining; incomplete, unsuccessful or painful evacu-

ation; bowel infrequency; abdominal pain and bloating.

After exclusion of secondary causes (obstructing colonic

lesions, neurological, metabolic and endocrine disor-

ders), the pathophysiology of CC can broadly be

divided into problems of colonic contractile activity

(and thus stool transit) and problems allied to rectal

emptying (evacuation disorder). A combination of clini-

cal expertise and specialist radio-physiological investiga-

tions can determine which patients have slow colonic

transit, evacuation disorder, both (in whom transit is

usually characterized by a left-sided delay) or neither

(no abnormality found with current tests) [12]. Evacua-

tion disorders can be further subdivided into those with

a structurally significant pelvic floor abnormality (usually

as a consequence of pelvic floor weakness or injury) e.g.

rectocoele or internal prolapse (intussusception), and

those characterized by a dynamic failure of evacuation

without structural abnormality: most commonly termed

‘functional defaecation disorder (FDD) [13]’ (Fig. 1).

The management of CC is a major problem due to

its high prevalence and lack of widespread specialist

expertise. In general, a step-wise approach is under-

taken, with first line conservative treatment such as life-

style advice and laxatives (primary care) followed by

nurse-led bowel re-training programs, sometimes

including focused biofeedback and psychosocial support

(secondary/tertiary care). Although these treatments

may improve symptoms in more than half of patients

[14], patients with intractable symptoms and impaired

QOL may subsequently be offered a range of surgical

interventions.

Surgical decision-making is greatly influenced by local

expertise, commissioning or reimbursement, and per-

sonal enthusiasm for particular interventions. While

robust diagnosis of specific pathophysiologies combined

with multidisciplinary team discussion may help direct

surgery, in the absence of an agreed pathway to stratify

patients, there is a current large and difficult-to-justify

variation in surgical practice that continues to risk inade-

quately-informed and potentially harmful interventions

being offered. The need to reduce such variations in prac-

tice, based on available evidence, has been a recurrent

theme of recent national specialty group discussions (e.g.

ACPGBI) with various initiatives proposed. As part of the

Chronic Constipation Treatment PathwaY (CapaCiTY)

programme funded by National Institute of Health

Research (NIHR), a multi-disciplinary working group

was convened in July 2014 to address this need. This

group of medical and nursing experts included members

of The Pelvic Floor Society and urogynaecology expertise

derived from the International Continence Society (ICS).

As a prelude to developing new evidence from trials

within the CapaCiTY programme, it was agreed that the

current surgical evidence base would benefit from coales-

cence in the form of systematic review and graded prac-

tice recommendations. This paper and the accompanying

subsequent six papers address this aim.

Methods

Systematic review

Protocol and registrationThe authors developed the protocol for review, detail-

ing pre-specified methods of the analysis and eligibility

for the review in accord with 2009 PRISMA guidance

[15] using also the new reporting elements derived

from the 2016 harms checklist [16]. While the protocol

was not registered, a description of the NIHR Capa-

CITY programme is available in the public domain

(http://www.isrctn.com/ISRCTN11747152) and has

been presented nationally (DDF meeting, London

2015; National Pelvic Floor Meeting, Manchester

2015).

Eligibility criteria

Study characteristics

Study characteristics were defined using the PICOS

framework. Search term definitions were inclusive, pro-

moting a sensitive search of studies reporting surgical

interventions for chronic constipation.



Surgery for constipation C. H. Knowles et al.

http://www.isrctn.com/ISRCTN11747152

Population: The review aimed to identify studies of

patients undergoing surgical interventions with the pri-

mary intent of treating chronic constipation. The defini-

tion of chronic constipation is neither straightforward

nor uniformly applied [17]. On this basis, all common

terms encompassing problematic defecation were used

(see search strategy syntax: Appendix I). However, sev-

eral pelvic floor procedures may be performed com-

monly for non-chronic constipation indications.

Examples include pelvic organ prolapse syndromes

where the physical prolapse or other organ dysfunctions

of the vagina or bladder are the main motivation for

surgery. While such patients invariably also have some

degree of defaecatory problems, and their perioperative

data could still be used to inform procedural safety,

these patients may phenotypically differ at baseline and

in response to surgical intervention even if the interven-

tion itself is identical or at least similar. Cochrane

reviews such as ‘surgical repair of pelvic organ prolapse

in women’ [18] and of surgical management of external

rectal prolapse [19] include some RCTs where defaeca-

tory symptoms are recorded as a secondary outcome or

as a complication but not as a primary presenting com-

plaint of the population studied. Thus these were ineli-

gible for inclusion. Similarly, for colonic excisional

procedures, patients with the very rare diagnoses of

adult Hirschsprung disease or idiopathic megacolon-

megarectum [20] were considered distinct from chronic

constipation and thus not included. Some studies

reported outcomes on two populations, only one of

which was eligible e.g. internal and external rectal pro-

lapse. Where such data could not be separated by

population, the study was also deemed ineligible for

inclusion.

A minimum population sample of 20 patients was

imposed for eligibility. This threshold was taken to

exclude case reports and small case series that often

reported a single surgeon’s personal experience or early

experience of experimental procedures.

Intervention: Surgical procedures for chronic consti-

pation are subject to heterogeneous descriptions. On

this basis, an iterative approach was taken by cross refer-

encing e.g. with textbook reference lists to ensure that

all terms in common usage were incorporated in the

eventual search strategy. These included some genuine

procedural variations but also multiple small changes in

syntax for the same procedure e.g. ‘stapled transanal

rectal resection’ vs ‘stapled transanal rectum resection’.

A decision was taken by the review team that results

would be grouped by five main approaches to surgically

treating chronic constipation: (i) colonic resection, (ii)

hitching procedures of the rectum (rectal suspension);

(iii) excisional procedures of the rectal wall (rectal exci-

sion); (iv) reinforcement of the rectovaginal septum

(RV reinforcement); and (v) sacral nerve stimulation

(SNS). This approach was taken because initial review

(Oct 2014) determined that other procedures either

lacked sufficient evidence for review. The first major

exclusion on this basis were stomas leading to intestinal

discontinuity or for the purpose of administering bowel

irrigation (continence enema). It is acknowledged that

in the real world many patients have stomas either

deliberately or as an eventual outcome of other surgery.

Figure 1 Schematic of pathophysiology

of chronic constipation.



C. H. Knowles et al. Surgery for constipation

However, eligible studies were sparse after application

of inclusion criteria and markedly heterogeneous

between and within studies (patients and techniques).

Other procedures were excluded if still considered

experimental e.g. colonic exclusion procedures [21].

Comparisons: Studies were eligible regardless of

whether they were retrospective or prospective in

design, controlled or uncontrolled. Only a minority of

studies reported more than one procedure or more than

one population.

Outcomes: Studies were broadly eligible if they pro-

vided extractable data on benefit (treatment efficacy),

risk (harms) or both. For efficacy, inclusion necessitated

the acceptance of the huge disparity in quality of out-

comes reporting that are well acknowledged in the liter-

ature [14], with a heavy reliance on estimates of global

patient satisfaction with the procedure (an indirect

measure of the patients own judgement of their post-

operative state compared to their pre-operative state).

Studies of physiological and anatomical outcomes alone

were excluded since these are generally regarded as a

poor surrogate of efficacy in this patient population

[22]. Because the outcomes of surgical interventions for

chronic constipation are known to exhibit a ‘honey-

moon period’ in the months immediately following sur-

gery, a minimum (mean or median) follow up of

12 months was applied for eligibility. It is acknowl-

edged that enforcement of this criteria excluded some

level I studies. Several studies reported the outcomes of

more than one procedure. Where such data could not

be separated by procedure, these were not included

(often resulting in study ineligibility).

Report characteristicsYear of publication: Any publication date was eligible as

covered by database search from 1960 to the date of

final search (22nd February 2016).

Language: Due to the large number of studies

retrieved, it was decided to include only studies with

full text in the English language. While the numbers of

foreign language studies were small, these have been

detailed for the reader in ‘reasons for exclusion’ at the

full-text stage (rather than at the abstract screening

stage). There is reasonable evidence to suggest that

searching only in English does not have an adverse

effect on the quality of systematic reviews [23].

Type of study: Only peer-reviewed publications

reporting primary data were eligible. Thus reviews, edi-

torials, letters and other forms of secondary expert

opinion were excluded at the screening stage. Only full

manuscripts were eligible thus conference abstracts and

proceedings were also excluded. No constraint was

imposed based on level of evidence. This decision was

taken in the knowledge that the vast majority of data

would be extracted from case series rather than higher

quality study types.

Information sourcesThe senior author (CK) performed a comprehensive

search of the literature on 22nd February 2016 using

PubMed and Evidence Based Medicine reviews (includ-

ing the Cochrane database of systematic reviews and the

Cochrane central register of controlled trials). A prelim-

inary search in 2014 had determined that Embase and

Web of Science led to almost 2000 duplicate records

with no additional yield. Search terms used a sensitive

combination of population, intervention and report

terms. A keyword and hand search was used within rele-

vant Cochrane systematic reviews. The specific search

terms are listed in Appendix I.

Study selectionScreening was performed at the abstract level by the

senior author (CK), excluding studies not meeting eligi-

bility criteria where this could be readily determined

from the abstract alone. Full-text copies of all remaining

English language studies were obtained and assessed by

reviewers, who were un-blinded to the names of studies,

authors, institutions or publications. Disagreement

regarding inclusion was resolved by the senior author

(CK). Duplicate data sets generated from the same

cohort of patients were excluded with the larger popula-

tion size and longer follow-up cohort included at the

expense of earlier reports from the same cohort. In

instances of doubt, authors from the relevant institu-

tions were contacted to confirm or refute any repetition

of results (performed on three occasions).

Search results were cross-referenced to bibliographies

from other sources (previous reviews and book chap-

ters). Care was taken that any studies missed by the

original search met the strict inclusion criteria and did

not circumnavigate the carefully-defined search strategy

especially in relation to population terms.

Data collection processOutcome data were extracted by the junior authorship

team (UG, EJH, DP, PFV) paired with one senior

author for each procedure: colonic resections (CK); rec-

tal hitching procedures (SB); rectovaginal septum rein-

forcement (ABW); rectal wall excision (MM-J); sacral

nerve stimulation (SP). Data were extracted to a stan-

dardized template (Microsoft Excel spreadsheet) includ-

ing study characteristics and outcome data (see below).




For each procedure, one reviewer extracted the data

and one verified content.

Data itemsA full list of data fields is included in Table 1 (with

annotation). These followed the PICOS framework with

outcomes broadly divided into those assessing harms

(intra- and perioperative complications and long-term

adverse outcomes), and those assessing efficacy: global

success ratings and functional outcomes (organized into

validated symptom, QOL scoring instruments and indi-

vidual symptoms). For perioperative complications,

some consideration was given to classifying complica-

tions by established systems e.g. Clavien-Dindo however

inconsistencies in reporting made this unfeasible. Data

were not collected in relation to cost effectiveness which

was deemed to fall outside the remit of the process

aims. To simplify data extraction and presentation, for

ordinal data, summary statistics were extracted as mean

or median (with SD when provided).

Individual study quality and risk of biasThe methodological quality of all individual included

studies was assessed by the senior author (CK) and classi-

fied in accord with Oxford CEBM levels of evidence defi-

nitions for ‘therapy or harm’ [16]. The following rules

were applied accepting that distinguishing study designs

can be problematic for observational studies [24]:

1 A study was deemed prospective if this was categori-

cally stated or if patients were ‘enrolled’ or ‘re-

cruited’ to a study that systematically recorded pre-

and post-operative data. All other studies were

assumed to be retrospective.

2 A cohort study was defined as one designed to address a

clear stated aim or hypothesis using specified analytical

methods. In general, these included a comparison

group related either to the relative efficacy of more than

one specified procedure or to patient selection where a

specified baseline ‘risk factor’ was analysed in relation to

relative success or failure of the intervention.

3 A case series was defined as a report of observations

based on clinical practice. Such studies may generate

hypotheses by post-hoc case comparisons.

4 For randomized trials and cohort studies, Cochrane

risk of bias tools were applied [http://ohg.cochrane.

org/sites/ohg.cochrane.org/files/uploads/Risk%20of

%20bias%20assessment%20tool.pdf] and used to dis-

tinguish between high and low quality RCTs

(Oxford level 1b or level 2b) and high and low qual-

ity cohort studies (Oxford level 2b or level 4). Case

control studies were assessed using the National

Institutes of Health (NIH) quality assessment tool

[http://www.nhlbi.nih.gov/health-pro/guidelines/

in-develop/cardiovascular-risk-reduction/tools/case-

control] (Oxford level 3b or 4).

Further sub-analysis of the quality of observational

studies (e.g. compliance with STROBE, Newcastle-Ottawa

or MINORS) was not undertaken as it was felt that this

would add little to the overall assessment of quality.

Summary measuresResults were tabulated by outcome and described with

appropriate summary statistics (percentages, means and

ranges). For very rare events, the aggregate number and

denominator were reported. Quantitative data synthesis

was performed for key outcomes using meta-analysis in

STATA SE v14. Pooled proportions and means were

estimated, permitting exploration of heterogeneity and

bias. Where continuous measures failed to report mea-

sures of variance these were approximated as range/4.

Random effect meta-analytic models were estimated to

characterise rates of events and heterogeneity between

studies, with sub-grouping by procedure. Where studies

did not provide data in a useful summary form, available

data were tabulated but not included in the meta-analy-

sis. Results were presented as aggregate means with

confidence intervals and graphically displayed within

Forest plots. For pooled studies, the I2 value (reflecting

intra-group heterogeneity) was reported and interpreted in

accord with published guidance where 0–40% = hetero-

geneity might not be important, 30–60% = moderate

heterogeneity, 50–70% substantial heterogeneity and

75–100% = considerable heterogeneity [25]. The mag-

nitude and direction of effect, and strength of evidence

P-value from the chi-squared test, were used to inter-

pret the importance of heterogeneity.

Evidence within reviews was predominantly provided

by observational cohort data with relatively few experi-

mental studies (trials) identified. Consequently, the

reviews analyse all studies as individual cohorts, by pro-

cedure, to achieve inclusion and consistency; pooled

findings are compared with the findings of individual

trials. Where several trials were identified within a

review (e.g. rectal excision procedures) meta-analyses

was performed with sub-grouping by procedure and by

evidence grade. Findings by evidence grade were

reported only when they deviated qualitatively from the

overall pooled summary. Given the nature and reporting

of data, study-level meta-regression was not attempted.

Risk of bias across studiesPublication bias was assessed for outcomes where meta-

analysis was performed. Other limited analysis was per-

formed based on study size, design and publication date

where this contributed to interpretation. Subgroup analy-

sis was explored for the main procedural variations.




http://ohg.cochrane.org/sites/ohg.cochrane.org/files/uploads/Risk%20of%20bias%20assessment%20tool.pdf



http://www.nhlbi.nih.gov/health-pro/guidelines/in-develop/cardiovascular-risk-reduction/tools/case-control



Funding statementThis review was funded by the NIHR Programme

Grant for Applied Research Programme (Ref: RP-PG-

0612-20001) who had no role in study design, data

collection, analysis, interpretation, writing of the report

or the decision to submit the paper.

Clinical guidance development

AimsThe process had three main aims:

1 Development of summary evidence statements;

2 Development of graded practice recommendations;

3 Development of summary research recommenda-

tions.

Development of summary evidence statementsSummary evidence statements were produced by the

Clinical Guidance Group (CGG). This group was con-

vened in summer 2014. A final list of participants was

selected primarily from colorectal surgeons, gastroen-

terologists, urogynaecologists and specialist nurses with

a strong interest in functional colorectal and pelvic floor

disorders. This group included all senior authors of the

Table 1 Data field for systematic review.

Data extract Description Notes


First author Text(num) With citation number

Year publication Text To 2016

Number of pts Number Ordinal integer

Follow up Months Mean or median as documented in study (integer)

Study design Text abbreviation As Oxford CEBM levels of evidence

Evidence grade IA–IV As Oxford CEBM levels of evidence

Population

Disease Text abbreviation As supplied key

Sex ratio Female:male Ratio not simplified

Age Years (integer) Mean or median as supplied (range)

Intervention

Operation (s) Text abbreviation As supplied key

Op duration Minutes Mean (integer)

Length of stay Days Mean to 1 decimal place

Outcomes

Harms

Perioperative

Total cx Percentage % to 1 decimal place

Infective cx Percentage % to 1 decimal place

Bleeding cx Percentage % to 1 decimal place

Proc specific cx Percentage As per specific procedure: % to 1 decimal place

Mortality Percentage % to 1 decimal place

Repeat intervention Percentage Generally procedure specific for complications

or poor functional outcome

Mortality rate Number Absolute number over reported denominator

Adverse long-term symptoms Percentage Some procedural specificity: Includes re-operation

rate where relevant

Efficacy

Global success rating Scale Very commonly employed: % patients with good or

excellent outcomes unless specified

Symptom scores Count Several variably validated summative scoring instruments:

pre and post or post only as available: mean + SD

Individual symptoms Percentage Some procedural specificity: pre and post or post

only as available

QOL measures Count or scale Few instruments used: pre and post or post only as

available: mean + SD

Cx, complications.




five reviews and associated junior investigators. Method-

ological expertise was provided by Professor James

Mason (University of Warwick), and NHS Specialised

Services stakeholder representation by Mr Mark Chap-

man. A series of meetings followed (Bristol, November

2014; London, June 2015; Manchester, November

2015; and Edinburgh, July 2016) at which the evolving

summary evidence statements (from reviews) were even-

tually ratified and prototype clinical practice recommen-

dations drafted.

The CGG used ‘focus group’ methodology to gain

consensus by in silico and face to face meetings. The num-

ber of participants (> 12), and four rounds of written revi-

sions fulfilled the basic criteria required for a guideline

decision group (National Institute for Health and Clinical

Excellence, April 2007) and allowed a sufficiently reliable

process at an acceptable cost in terms of travel, expenses

etc. The heterogeneity of the group (specialty, nationality,

expertise) was deemed desirable to be representative of a

range of stakeholders. Agreement was defined without

‘weighting’ of any participant’s views, although some par-

ticipants contributed more than others to the process.

Using the synthesis of the evidence base the group

drafted statements of evidence based on best evidence

available (which varied significantly by procedure). The

clinical guidance group discussed, revised and graded

summary statements of evidence level using the Oxford

2009 CEBM system (http://www.cebm.net/oxford-ce

ntre-evidence-based-medicine-levels-evidence-march-2009)

(Table 2) based on the review of evidence. For clarity,

roman numerals (I–IV) were used to denote summary

levels of evidence for graded evidence in contrast to

Arabic numerals for individual studies, e.g. 1a, 2b etc.

Summary levels could apply either positively or nega-

tively to each procedure. Care was taken to avoid any

contamination of expert opinion into statements, these

thus solely reflecting summated evidence from system-

atic review. Some language used in summary evidence

statements was deliberately chosen to reflect use of

pooled data. Thus the term ‘typical’ or ‘typically’ specif-

ically denotes that data for the event in question have

been derived from random effects analysis.

Development of graded practice recommendations(GPRs)This had two main stages: (i) development of ‘prototype’

GPRs by the Clinical Guidance Group, and (ii) develop-

ment of a final GPR list by a European Consensus group.

This approach, including the methodology used

(RAND/UCLA – see below) is established and has been

used previously in the coloproctology field [26].

Development of prototype GPRs: After a common

understanding of the evidence was established, group

discussion balanced clinical experience and evidence sum-

maries to arrive at shared judgements about recommen-

dations for care, thus deriving relevant recommendations

for decision making in clinical practice. Group processes

risk personal bias based on ‘eminence’ or ‘eloquence’ if

led and supported ineffectively: adequate methodological

support in the use of evidence and dialectic was provided

to support the process to ensure a balance of views as well

as to promote generalizability and impact. This stage

embodied summary evidence statements (from each

review), data from some excluded level I studies (e.g.

RCTs that were excluded for short follow up or pub-

lished after the review date) (a further search was run by

CK on 03.10.16 for the date range 22.02.16 to 03.10.16

including original terms and ‘clinical trial’) and expert

opinion derived from the decision group and selected

prior published guidance documents (Oxford 5) (Fig. 2).

Final grading followed Oxford CEBM recommenda-

tions (A–D) [27] [Table 3]. As with levels of evidence

the grades of evidence could apply either positively or

negatively to the procedure.

Development of final GPRs: The European Consensus

group comprised a panel of European experts (colorectal

and pelvic floor surgeons) nominated by the European

Society of Coloproctology (ESCP). Twenty experts were

invited from 10 European countries of whom 18 partici-

pated from nine countries (Appendix II).

Consensus methodology was derived from the

RAND/UCLA Appropriateness Method (Prepared for

Directorate General XII, European Commission 2001)

[28]. Prototype Graded Practice Recommendations

(derived from the clinical guidance group) were pre-

sented (on a spreadsheet) for each procedure under three

subheadings: ‘patient selection’, ‘procedural considera-

tions’ and ‘patient counselling’. For each, a number of

GPRs were listed, each with associated levels of evidence

and grade of prototype recommendation. For each, con-

sensus panellists were asked ‘Does this recommendation

lead to an expected health benefit that exceeds the

expected negative consequences of its introduction?’

Examples of health benefits in this context could be

improved surgical outcome, improved patient experience,

improved functional capacity etc.; the negative conse-

quences could include increased morbidity, anxiety, pain,

time lost from work, denial of an investigation or treat-

ment. Panellists were asked to base their judgement on

clinical grounds only, i.e. exclusive of financial cost [29].

Responses to each listed recommendation used a lin-

ear analogue scale of 1–9 to assess views on the benefit-

to-harm ratio. Using this scale, a score of 1–3 indicated

that they expected the harms of introducing the recom-

mendation to greatly outweigh the expected benefits




http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009

http://www.cebm.net/oxford-centre-evidence-based-medicine-levels-evidence-march-2009

and a score of 7–9 that the expected benefits greatly

outweighed the expected harms. A middle rating of 4–6could mean either that the harms and benefits were

considered about equal or that the panellist was unable

to make a judgement for the recommendation. Panel-

lists were asked to try and provide a response for all

listed recommendations.

Responses were analysed in accordance with the first

phase of RAND/UCLA guidance, with each recom-

mendation classified as ‘appropriate,’ ‘uncertain’ or

‘inappropriate’ according to the panellists’ median score

and the level of disagreement. Indications with median

scores in the 1–3 range were classified as inappropriate,

those in the 4–6 range as uncertain, and those in the 7–9 range as appropriate. All indications rated ‘with dis-

agreement,’ whatever the median, were classified as

uncertain. ‘Disagreement’ here basically implied a lack

of consensus, either because of polarisation or spread

over the entire scale (defined for a sample of 18 pan-

elists as > 5 rating the indication outside the 3-point

region [1–9,28]). Further phases of consensus followingdiscussion to reduce variation were not conducted.

Summary research recommendationsOne of the initial drivers for this process (NIHR Capa-

CiTY) was the need to define the main evidence needed

for future surgical trials of patients with CC. During

the development of this guidance, some trials have com-

menced patient recruitment such as CapaCiTY study 3

(RCT of laparoscopic ventral rectopexy). There is how-

ever still a great need to define research questions that

could inform future UK and international commission-

ing of research funding. Research recommendations

Table 2 (a) Oxford CEBM (2009) summary levels of evidence and (b) grades of recommendation.

(a) Summary level

of evidence Type of studies

Evidence

included specific

to review

Notes specific to review

exclusions

I High quality RCT

All or none study

Oxford 1b,

1c*

1a (SR RCTs) excluded since no

secondary research included in

systematic review

II Poor quality RCT

Individual high quality

cohort study

Ecological study

Oxford 2b

2c*

2a (SR cohort studies) excluded

since no secondary research

included in systematic review

III Individual high quality

case-control study

Oxford 3b* 3a (SR case-control studies)

excluded since no secondary

research included in systematic

review

IV Case series and poor

quality cohort and

case-control studies

Oxford 4 The majority of studies included

in systematic review

V Expert opinion, bench

research

Oxford 5 Excluded in systematic review

(b) Grades of recommendation Evidence required

A Consistent level 1 studies

B Consistent level 2 or 3 studies or extrapolations from level 1 studies

C Level 4 studies or extrapolations from level 2 or 3 studies

D Troublingly inconsistent or inconclusive studies of any level (I–IV)

N Recommendation based on clinical understanding in the absence of evidence†

*No studies of these designs found by search for any procedure.

†But where a recommendation was considered necessary to highlight the absence of evidence for an important practice point.

Figure 2 Schematic showing process of transition from sum-

mary evidence statements to graded practice recommendations.




have been attributed a priority (high, medium or low)

based on the expert opinion of the current working

group and may help inform discussion about future

funding priorities.

Presentation of results

In view of the large scale of the systematic review and

prototype guidance process, results have been presented

as a series of separate manuscripts:

1 Overview of search results and study characteristics

(this manuscript);

2 Systematic review results and summary evidence

statements for colonic resection;

3 Systematic review results and summary evidence state-

ments for procedures characterized by rectal suspension;

4 Systematic review results and summary evidence state-

ments for procedures characterized by rectal wall excision;


statements for procedures characterized by rectovagi-

nal septum reinforcement;


statements for sacral nerve stimulation;

7 Coalescence of systematic review data, summary of graded

practice recommendations and research recommendations.

The main conclusions of this process were presented

at the Pelvic Floor Society Meeting in Cardiff, January

2017.

Overview of search results

Study selectionFigure 3 (PRISMA flow diagram) shows the results of

population and intervention term searches with reasons

for exclusion of studies at the full text review stage.

Table 3 Reviewed studies by main procedure type and evi-

dence level.

Procedure

Number of reviewed studies

by evidence level

1b 2b 3b 4 Total

Colonic resection 0 1 0 39 40

Rectal suspension procedures 0 2 0 16 18

Rectal excisional procedures 3 26 0 18 47

RV Reinforcement procedures 1 10 0 33 44

Sacral nerve stimulation 0 0 0 7 7

ALL 4 39 0 113 156

Figure 3 PRISMA diagram showing all review results.




Study characteristicsTable 3 gives information on the overall study charac-

teristics and by procedure. Detailed data on individual

reviewed studies are provided by procedure type in the

accompanying papers. It can readily be noted that the

overall quality of evidence was poor with 113/156

(72.4%) providing only level IV evidence. The best evi-

dence to date exists for rectal excisional procedures

where the majority of studies where level I or II. This is

discussed further in the final graded practice recommen-

dations and research recommendations paper.

Acknowledgements

We would like to acknowledge the following people in

relation to the NIHR CapaCiTY working group: Mr Ste-

ven Brown, Sheffield Teaching Hospitals NHS Founda-

tion Trust; Mr Kenneth Campbell, The University of

Dundee, NHS Education for Scotland; Mr Mark Chap-

man, Heart of England NHS Trust; Mr Andrew Clarke,

Poole Hospital NHS Foundation Trust; Mr Neil Cruick-

shank, Sandwell and West Birmingham Hospitals NHS

Trust; Mr Anthony Dixon, University of Bristol, Bristol,

UK; Dr Christopher Emmett, County Durham and Dar-

lington NHS Foundation Trust; Mr Ugo Grossi, Queen

Mary University of London; Dr Richard Hooper, PCTU,

Queen Mary University of London; Miss Emma Hor-

rocks, University Hospital Southampton NHS Founda-

tion Trust; Professor Charles Knowles, Queen Mary

University of London; Mr Jon Lacy-Colson, Shrewsbury

and Telford Hospital NHS Trust; Mr Ian Lindsey,

Oxford University Hospitals NHS Trust; Professor James

Mason, University of Warwick, Coventry; Mr Mark Mer-

cer-Jones, Gateshead Health NHS Foundation Trust; Mr

Andrew Miller, University Hospitals of Leicester NHS

Trust; Mr David Pares, Hospital Germans Trias i Pujol,

Barcelona, Spain; Miss Sophie Pilkington, University

Hospital Southampton NHS Foundation Trust; Mr Neil

Smart, Royal Devon & Exeter NHS Foundation Trust;

Ms Natasha Stevens, PCTU, Queen Mary University of

London; Professor Douglas Tincello, University Hospi-

tals of Leicester NHS Trust; Miss Karen Telford, South

Manchester NHS Foundation Trust; Mr Paul Vollebregt,

Queen Mary University of London; Mr Andrew Wil-

liams, Guy’s and Thomas’ NHS Foundation Trust; Pro-

fessor Yan Yiannakou, County Durham and Darlington

NHS Foundation Trust.

Funding

This project was funded by the National Institute for

Health Research (NIHR) Programme Grant for Applied

Research (RP-PG-0612-20001). The views and opinions

expressed in this report are those of the authors and are

not those of the PGfAR Programme, NIHR, the UK

National Health Service, or the UK Department of Health.

Conflicts of interest

All authors have no conflict of interest in relation to

the content of the manuscript. In the last 2 years,

C.H. Knowles has received speaker fees and consul-

tancy payments from Medtronic Inc., S. Brown has

received speaker fees and consultancy payments from

Allergan. M. Mercer-Jones has received fees as a pre-

ceptor for Medtronic Inc. and A.B. Williams has

received speaker fees and consultancy payments from

Medtronic Inc., and acts as a non-payed consultant for

Cook Medical. M. Chapman has received funding to

attend courses from Medtronic Inc.

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Appendix I: Search strategy

Population terms

“constipation”[All Fields] OR “obstructed defecation”[All

Fields] OR “colonic inertia”[All Fields] OR

“intussusception”[All Fields] OR “rectal prolapse”[All Fields]

OR “outlet obstruction”[All fields] OR “SRUS”[All Fields]

OR “solitary rectal”[All Fields] OR “defecation disorder”[All

Fields]) OR “impaired defecation”[All Fields] OR “rectal

emptying”[All Fields] OR “bowel dysfunction”[All Fields]

OR “bowel function”[All Fields] OR “defecography”[All

Fields] OR “defaecography”[All Fields] OR

“defecographic”[All Fields] OR “evacuation difficulty”[All

Fields] OR “evacuation disorder”[All Fields] OR

(“Constipation”[Mesh Terms]) NOT (“child”[MeSH

Terms]).

Intervention terms

“Delorme procedure”[All Fields] OR “delormes

procedure”[All Fields] OR “delorme’s procedure”[All Fields]

OR “sacral nerve stimulation”[All Fields] OR “sacral

neuromodulation”[All Fields] OR “neurostimulation”[All

Fields] OR “sacral nerve modulation”[All Fields] OR

“STARR”[All Fields] OR “stapled transanal resection”[All

Fields] OR “stapled transanal rectal resection” [All Fields]

OR “trans-STARR”[All Fields] OR “Stapled trans-anal rectal

resection”[All Fields] OR “rectopexy”[All Fields] OR

“sacrocolpopexy”[All Fields] OR “sacropexy”[All Fields] OR

“promontofixation”[All Fields] OR “colectomy”[All Fields]

OR “proctocolectomy”[All Fields] OR “ileorectal”[All Fields]

OR “cecorectal” [All Fields] OR “ileoproctostomy”[All

Fields] OR “cecoproctostomy”[All Fields] OR

“ileosigmoid”[All Fields] OR “rectocele repair”[All Fields]

OR “posterior repair”[All Fields] OR “colporrhaphy”[All

Fields] OR “rectovaginal septum reinforcement”[All Fields]

OR “anterior rectal wall repair”[All Fields] OR “surgical

repair of rectocele”[All Fields] OR (“transperineal mesh

repair”[All Fields] OR “transperineal repair”[All Fields] OR

“transvaginal repair”[All Fields] OR “transanal repair”[All

Fields] OR “endorectal repair”[All Fields] OR “transrectal

repair”[All Fields] OR “transanal longitudinal plication”[All

Fields] OR (“Constipation/surgery”[Mesh Terms])

Report terms

(hasabstract[text]) AND (“0001/01/01”[PDat]: “2016/02/

22”[PDat])




http://handbook.cochrane.org

Appendix II: European reference group*

Name Institution

Donato Altomare Bari, Italy

Lars Boenicke Wuerzburg, Germany

Steen Buntzen Tromsø, Norway

Ken Campbell Dundee, UK

Peter Christensen Aarhus, Denmark

Andre D’Hoore Leuven, Belgium

Eloy Espin Barcelona, Spain

David Jayne Leeds, UK

Oliver Jones Oxford, UK

Jens-Christian Knapp Stavanger, Norway

Soren Laurberg Aarhus, Denmark

Paul Lehur Nantes, France

Klaus Matzel Erlangen, Germany

Ronan O’Connell Dublin, Ireland

Michel Prud’homme N̂ımes, France

Carlo Ratto Rome, Italy

Mario Trompetto Turin, Italy

Caroline Vaizey London, UK

*Derived from European Society of Coloproctology.




Surgery for constipation: systematic review and practicerecommendations

Results I: Colonic resection

C. H. Knowles*, U. Grossi*, M. Chapman†, J. Mason‡, on behalf of the NIHR CapaCiTY working

group§ and Pelvic floor Society¶*National Bowel Research Centre, Blizard Institute, Queen Mary University London, London, UK, †Good Hope Hospital, Heart of England NHS Trust,

Birmingham, UK, ‡University of Warwick, Coventry, UK, §National Institute for Health Research: Chronic Constipation Treatment Pathway, and

¶Affiliate section of the Association of Coloproctology of Great Britain and Ireland

Abstract

Aim To assess the outcomes of colectomy in adults

with chronic constipation (CC).

Method Standardised methods and reporting of bene-

fits and harms were used for all CapaCiTY reviews that

closely adhered to PRISMA 2016 guidance. Main con-

clusions were presented as summary evidence statements

(SES) with a summative Oxford Centre for Evidence-

Based Medicine (2009) level.

Results Forty articles were identified, providing data on

outcomes in 2045 patients. Evidence was derived

almost exclusively from observational studies, the major-

ity of which concerned colectomy and ileorectal anasto-

mosis (CIRA) rather than other procedural variations.

Average length of stay (LOS) ranged between 7–15 days. Although inconsistent, laparoscopic surgery

may be associated with longer mean operating times

(210 vs 167 min) and modest decreases in LOS (10–8 days). Complications occurred in approximately 24%

of patients. Six (0.4%) procedure-related deaths were

observed. Recurrent episodes of small bowel obstruc-

tion occurred in about 15% (95%CI: 10–21%) of

patients in the long-term, with significant burden of re-

hospitalisation and frequent recourse to surgery. Most

patients reported a satisfactory or good outcome after

colectomy but negative long-term functional outcomes

persist in a minority of patients. The influence of resec-

tion extent, anastomotic configuration and method of

access on complication rates remains uncertain. Avail-

able evidence weakly supports selection of patients with

an isolated slow-transit phenotype.

Conclusion Colectomy for CC may benefit some

patients but at the cost of substantial short- and long-

term morbidity. Current evidence is insufficient to

guide patient or procedural selection.

Keywords Constipation, colectomy, ileorectal, slow-

transit

Introduction

Background and procedural variations

The concept of resection of the colon to treat constipa-

tion originates more than a century ago [1]. Modern

surgical approaches mostly continue in the historical

practice of removing the whole colon with anastomosis

of the terminal ileum to the upper rectum (or very dis-

tal sigmoid) usually at the level of the sacral promon-

tory. Usually termed colectomy and ileorectal

anastomosis (CIRA), the procedure is also sometimes

described as colectomy with ileoproctostomy. Total

colectomy is not favoured by all surgeons and other less

radical colonic resections may also be employed. The

simplest variation is to perform a subtotal colectomy

and ileosigmoid anastomosis (SCISA) but an increas-

ingly popular choice is subtotal colectomy with sparing

of the caecum and thence caecorectal anastomosis

(SCCRA). Since this is not a common procedure in

routine colorectal surgical practice, it merits some back-

ground description. First described by Ogilvie (1931),

retention of the ileocaecal junction has the theoretical

advantage of preservation of absorptive functions (bile,

vitamin B12 and electrolytes) and thus perhaps reduced

diarrhoea. No standard technique exists for creating a

CRA. The general principle involves colonic mobiliza-

tion followed by ligation of all vascular pedicles except

the ileocolic branches. In the technique proposed by

Correspondence to: Prof. C. H. Knowles, NBRC, 1st Floor Abernethy Building, 2

Newark St, London E1 2AT, UK.








Lillehei and Wangensteen (1955) a 180° rotation of the

remaining mesentery from the right to the left is per-

formed to place the caecum in the left iliac fossa, with

apex cephalad. During the rotation the remaining meso-

colon passes over the aorta, and it is sutured to the

mesorectum and to the third portion of the duodenum

to avoid internal hernia or intestinal obstruction, which

may complicate such technique. Deloyers (1963) pro-

posed a variation of this technique in which there is a

craniocaudal rotation of the caecum to allow a pelvic

isoperistaltic CRA (IPSCCRA) but this required a retro-

ileal tunnel and 180° torsion of the vascular pedicle

which may result in ischemia or venous stasis. These dif-

ficulties have in part be mitigated by development of an

antiperistaltic end-to-end caecorectal anastomosis (at-

tributed to Sarli [2]) (APSCCRA) which avoids the vas-

cular problems due to the torsion of the pedicle,

obviates the need to tailor the caecum and lowers the

risk of intestinal obstruction due to the rotation of the

mesocolon in front of the aorta.

Scope

Procedures considered beyond the scope of systematic

review [1–18] were:1 Total colonic and rectal excision (proctocolectomy).

These procedures have been variously employed for

chronic constipation with or without ileal pouch

formation in small numbers of patients and usually as

a salvage after failed colectomy;

2 Subtotal colectomy and modification of the rectal reser-

voir (modified Duhamel procedure; Jinling procedure);

3 Colonic exclusion and ileorectal anastomosis i.e.

without resection.

Previous reviews

Narrative reviews focused on the outcome of colectomy

for constipation have been published in 1996 [10],

1999 [11], and 2006 [12]. No previous systematic

review was identified.

Summary of search results and study quality

The search yielded a total of 85 manuscripts for full

text review (Fig. 1). From these, 40 articles published

between 1988 and 2015 contributed to the systematic

review, providing data on outcomes in a total of 2045

patients (range 20–144 patients per study) based on

39 defined patient cohorts (Table 1). A US nationwide

dataset derived from hospital episode statistics was also

included covering 2377 procedures coded as colectomy

for constipation indications [19]. Specific exclusions

after full-text review (and after exclusion of non-Eng-

lish language publications: n = 10) included 27 studies

where the population sample was confirmed to be less

Figure 1 PRISMA diagram.




than 20 patients, four studies of out of scope proce-

dures, one study where data were considered duplicate

[13], one where outcomes could not be segregated by

eligible procedure [14], and one where data for multi-

ple clinical indications for colectomy were merged

[15].

Table 1 All studies included in systematic review.

Author Year Centre Country Total N FU* Design Level†

Kamm [23] 1988 St Marks, London UK 44 > 12 RCS IV

Vasilevsky [24] 1988 Mayo Clinic, MN USA 52 46 RCS IV

Yoshioka & Keighley [25] 1989 Birmingham UK 40 36 RCS IV

Pemberton [26] 1991 Mayo Clinic, MN USA 36 36 PCS IV

Piccirillo [27] 1995 Cleveland Clinic, FL USA 54 27 RCS IV

Redmond [21] 1995 John Hopkins, Baltimore USA 34 90 PCH IIB

de Graaf [28] 1996 Rotterdam Netherlands 42 46 PCH IV

Lubowski [29] 1996 Sydney Australia 52 42 RCS IV

Platell [30] 1996 Perth Australia 96 60 RCS IV

Pluta [31] 1996 Alberta Canada 24 65 RCS IV

Ghosh [32] 1996 Edinburgh UK 21 96 RCS IV

Nyam [33] 1997 Singapore Singapore 74 56 PCH IV

Ho [34] 1997 Singapore Singapore 24 24 RCH IV

You [35] 1998 Taiwan China 40 24 PCS IV

Bernini [36] 1998 Mayo Clinic, MN USA 106 78 RCH IV

Hasegawa [37] 1999 Birmingham UK 61 84 RCH IV

Fan [38] 2000 Taiwan China 24 23 RCS IV

Pikarsky [39] 2001 Cleveland Clinic, FL USA 62 105 RCH IV

Pikarsky [40] 2001 Cleveland Clinic, FL USA 30 60 PCS IV

Webster & Dayton [41] 2001 Cancun Mexico 50 12 RCS IV

Mollen [42] 2001 Bennekom Netherlands 21 62 PCS IV

Nylund [43] 2001 Goteburg Sweden 40 132 PCS IV

Lundin [44] 2002 Uppsala Sweden 28 50 PCS IV

Fitzharris [45] 2003 Mayo Clinic, MN USA 75 47 RCS IV

Hassan [46] 2006 Mayo Clinic, MN USA 104 68 RCH IV

Marchesi [47] 2007 Parma Italy 23 72 PCS IV

Zutshi [48] 2007 Cleveland Clinic, OH USA 69 130 RCS IV

Feng [22] 2008 Zheijang China 79 47 RCH IIB

Hsiao [49] 2008 Taiwan China 44 12 PCS IV

Jiang [50] 2008 Whuhan China 37 48 RCH IV

Pinedo [51] 2009 Santiago Chile 20 25 RCS IV

Riss [52] 2009 Vienna Austria 20 84 RCS IV

Sohn [53] 2011 Soeul Korea 37 41 RCS IV

Xu LS [20] 2012 Harbin China 64 32‡ RCT IIB

Marchesi [54] 2012 Parma Italy 30 12 CCS IV

Wang [55] 2013 Zheijang China 124 12 RCH IV

Reshef [56] 2013 Cleveland Clinic, OH USA 144 43 RCH IV

Li [57] 2014 Chongqing China 72 64§ RCH IV

Sun [58] 2015 Shanghai China 48 36 RCH IV

Total 2045 47¶ –

Dudekula [19] 2015 US nationwide sample USA 2377** 12 RCH IV

RCS, retrospective cohort study; PCS, prospective cohort study; RCT, randomised controlled trial; CCS, case control study.

*Mean follow up in months.†Oxford CEBM [16].‡Only 4 days blinded.§For CIRA but 32 months for APSCCRA.¶Median value of follow up.

**181 for state sample and 56 with 12 months pre & post-intervention.




The general quality of studies was poor due to inade-

quate description of methods. The 40 included studies

comprised: a single poor quality randomized trial (uncertain

or high risk of bias in most domains) [20] (Oxford level

IIB); one good quality prospective [21] and one retrospec-

tive cohort study [22] (level IIB); and 37 level IV studies

(comprising 14 poor quality cohort studies, i.e. ‘case com-

parison studies’; one poor quality case-control study with

non-consecutive controls; eight prospective case series; and

14 retrospective case series). A general problem was the lack

of prospectively defined follow up intervals. Patient follow

up ranged from 12 months to 11 years (median

47 months) but this clearly varied greatly for individual

patients within studies without defined follow up periods.

Eleven studies derived from US centres, 11 from European

centres, nine from Chinese centres with the remaining nine

spilt across five countries.

Perioperative data

Perioperative data were reported by 37 studies

(Table 2). Reporting of procedure duration was incon-

sistent but mean procedural duration ranged from

approximately 2–4 h. Within this variation were trends

of shorter operating times for open vs laparoscopic pro-

cedures (e.g. colectomy and ileorectal anastomosis

(CIRA), median open: 167 min vs median laparoscopic:

210 min), as well as for subtotal procedures: median

135 min. The average length of stay (LOS) reported

was 10.4 days, ranging from 7.0 to 15.5 days duration.

However laparoscopic procedures consistently reported

shorter lengths of stay e.g. the median LOS for open

CIRA was 10.6 days compared to 8.1 days for laparo-

scopic CIRA. This evidence is supported by individual

cohort comparisons [34,55] and in the single RCT

where mean LOS was reduced from 9.7 to 7.6 days

with laparoscopy [20].

Summary evidence statements: perioperative data

1 Length of stay after colectomy for constipation is 7–15 days, even in the modern era (level IV).

2 Laparoscopic surgery may be associated with longer

operating times and modest decreases in length of

stay (from 10 to 8 days), however there is consider-

able variation between studies (level IV).

Harms

Perioperative complications

Presented meta-analyses showed considerable hetero-

geneity of complications, not explained by procedure

or age of publication. The attentiveness to harm

recording and the duration of recording were inconsis-

tent and studies limited only to laparoscopic procedures

are characterized by small numbers limiting scope for

comparison with open procedures and no adjustment

has been attempted for potential differences in the

populations recruited into individual studies. Conse-

quently estimates of harm provided are necessarily ten-

tative.

Surgical morbidity remains a concern for all types of

colectomy with total complication rates. A random

effects meta-analysis estimated total complications to be

24.4% (95%CI: 17.8–31.7%); I2 = 88.1% (Fig. 2),

although findings were heterogeneous including indi-

vidual study rates from 7% to 54% (Table 2). Aside

from the incidence of anastomotic leaks and other

more general complications (high even in some recent

series from expert centres [56] and including six fatali-

ties in 1568 patients: 0.4%) the incidence of prolonged

post-operative ileus (POI) and early adhesional small

bowel obstruction (SBO) are known to be dispropor-

tionally high for patients undergoing colectomy for

slow-transit constipation when compared to other indi-

cations [17].

A random effects meta-analysis estimated early post-

op POI/SBO to be 9.7% (95%CI: 5.7–14.6%);I2 = 87.9% (Fig. 3), although findings were heteroge-

neous including individual study rates from 0% to 33%.

Current findings are inconclusive as to whether laparo-

scopic or open surgery are safer: there is some sugges-

tion however that the POI rate is lower in newer

studies. Rates of further surgical intervention for POI in

the perioperative period were similarly heterogeneous:

2.7% (95%CI: 1.0–5.0%) I2 = 64.3%, including study

rates from 0% to 15%.

These data have been put into a broader context by

the recent (2015) US national database study of 2377

colectomies for constipation between 1998–2011 [19],

providing 60% of all subjects within the review. This

study based on registered health episodes re-affirms a

high rate of perioperative complications in a national

sample (42.7% patients during index hospitalisation 30-

day period), with the main contribution (27%) coming

from “intestinal obstruction, ileus, nausea & vomit-

ing”.

Long-term adverse outcomes

Long-term rates of SBO reported by studies were

heterogeneous: 15.2%, (95%CI: 10.2–20.9%)I2 = 85.5%, including study rates from 0% to 71%

(Table 3; Fig. 4a). Re-operation rates (principally for

SBO but also other severe ongoing functional




Table 2 Perioperative data by procedure.

Author Year N Time LOS Bleed Inf Total cx POI* Re-op Leak Mort

(a) Open colectomy and ileorectal anastomosis

Pemberton [26] 1991 36 NR 12.0 NR 8.3 22.2 13.0 0 0 0

Piccirillo [27] 1995 54 NR 7.0 NR NR NR 3.7 6 0 0

Redmond† [21] 1995 37 NR 12.1 NR NR 24 NR NR 0 0

Lubowski [29] 1996 52 NR NR NR NR NR NR NR 1.9 0

Pluta [31] 1996 24 NR NR 4.2 12.5 25 4.2 0 0 0

Ghosh [32] 1996 21 NR NR NR NR NR NR NR NK 0

Nyam [33] 1997 74 NR NR NR 9.0 NR 12.0 0 0 0

Ho [34] 1997 17 ‡ 10.6 NR 12.0 23.0 13.0 13.0 0 0

Bernini [36] 1998 106 NR NR NR NR NR 23.0 14.1 0 0

Fan [38] 2000 24 NR 10.0 NR NR NR NR 0 0 0

Pikarsky [40] 2001 30 NR NR NR NR NR NR NR 0 0

Webster & Dayton§ [41] 2001 55 NR 10.0 NR NR 42.0 32.0 NR 4.0 0

Mollen [42] 2001 21 NR NR NR NR 33.0 19.0 9.5 0 0

Nylund [43] 2001 40 NR NR 5.0 7.5 20.0 5.0 5.0 0 0

Fitzharris [45] 2003 75 NR NR NR NR NR NR NR 7 0.9

Hassan [46] 2006 65 NR NR NR NR NR NR NR 0 0

Jiang [50] 2008 21 140 15.5 NR 5.0 NR NR NR 0 0

Sohn [53] 2011 37 203 12.0 NR 5.4 13.5 10.8 2.7 2.7 0

Xu [20] 2012 32 145 9.7 NR NR NR 0 3.1 0 0

Wang [55] 2013 68 190 11.0 0 7.4 8.8 1.5 0 0 0

Li F [57] 2014 40 NR NR 1.25 2.5 32.5 15.0 7.5 2.5 0

(b) Series including open and laparoscopic colectomy and ileorectal anastomosis

Zutshi [48] 2007 69 NR 10.0 1.4 7.2 17.4 16.0 1.4 1.4 0

Riss [52] 2009 20 190 10.5 5.0 35.0 45.0 5.0 15.0 5.0 15.0

Reshef† [56] 2013 144 NR 7.8 3.5 17.0 54.0 26.0 14.0 6.9 1.0

Dudekula [19] 2015 2377 NR 8.0 NR NR 42.7 27.0¶ NR NR NR

(c) Laparoscopic colectomy and ileorectal anastomosis

Ho [34] 1997 7 NR** 9.2 NR 14 43.0 29 0 0 0

Xu [20] 2008 44 197 7.6 NR 4.5 18.2 11.4 4.5 2.3 0

Pinedo [51] 2009 20 248 7.0 10.0 NR NR 15.0 5.0 5.0 0

Xu [20] 2012 32 122 8.5 NR NR NR 0 3.1 3.1 0

Wang [55] 2013 56 223 8.7 0 5.3 7.1 1.8 0 0 0

Author Year Operation N Time LOS Bleed Inf Total cx POI* Re-op Leak Mort

(d) Subtotal colectomy and ileosigmoid anastomosis (ISA); isoperistaltic caecorectal anastomosis (IPCCA); antiperistaltic caecorectal

anastomosis (APCCA); lap: laparoscopic

de Graaf [28] 1996 ISA 24 NR NR NR NR NR NR NR NR 4.2

Feng [22] 2008 ISA 45 135 13.1 NR NR 20 NR 0 0 0

Sun [58] 2015 ISA 22 NR NR NR NR NR NR NR NR 0

Feng [22] 2008 IPCRA 34 120 12.5 NR NR NR NR 0 0 0

Li F [57] 2014 IPCRA 32 NR NR 0 3.1 28.1 12.5 3.1 3.1 0

Sun [58] 2015 IPCRA 26 NR NR NR NR NR NR NR NR 0

Marchesi [47] 2007 APCRA (5 lap) 17 NR 11.9 NR NR 9.3 5.9 11.8 5.9 0

Jiang [50] 2008 APCRA 17 130 14.5 NR 5.9 NR NR NR 0 0

Marchesi [54] 2012 APCRA 15 184 10.9 NR NR 13.3 0 0 0 0

Marchesi [54] 2012 APCRA lap 15 232 9.3 NR NR 13.3 0 0 6.7 0

Cx, complications; NR, not reported.

*Includes prolonged ileus and early mechanical obstruction.†In patients with STC only.‡70 min shorter than laparoscopic procedures in same series (actual duration not reported).§5 patients had colectomy and end ileostomy.¶Includes ‘intestinal obstruction, POI, nausea and vomiting, and haemorrhage’. POI, postoperative ileus.

**+/� rectopexy.




problems) were similarly heterogeneous 13.3%, (95%CI:

8.6–18.7%) I2 = 87.7%, including study rates from 0%

to 45% (Fig. 4b). Particular to colectomy for constipa-

tion is the concept that laparoscopy might reduce the

well-established high incidence of post-operative SBO.

The review provided only limited data from small stud-

ies comparing open with laparoscopic procedures,

although SBO rates appeared much lower. Ho et al.

[34] found that early adhesion formation leading to

bowel obstruction was more frequent in patients under-

going laparoscopically assisted colectomy (29%) com-

pared to open (13%). A larger series of 124 patients

also showed no differences in post-operative morbidity

between approaches [55]. Conversely, a low quality

case-control study of 15 laparoscopic vs 15 open subto-

tal colectomy with antiperistaltic CRA showed that

bowel obstruction rates were halved (from 13.3 to

6.7%) in the laparoscopic groups [54]. The follow up in

these studies (12–20 months) was generally shorter

than the average (47 months) although very high rates

of SBO were reported by a study of exclusively open

CIRA with 12 months follow up [52]. Finally, while

the results for laparoscopic approach offer some opti-

mism based on the small numbers of patients in these

studies, no differences were observed in complication

rates between open and laparoscopic procedures in the

US nationwide survey of 2377 colectomies [19].

However, the most revealing conclusions can be

drawn from further analysis of US national database

study in which longitudinal data were recorded on 166

patients recorded on State Inpatient Databases of Flor-

ida and California (2005–2011). These data agreed with

the whole national dataset (n = 2377) in confirming

high perioperative (30-day) complication and re-admis-

sion rates, but also showed that resource utilisation in

the form of emergency department visits, hospitalisation

and surgical intervention remained high in the following

1 year. Excluding the colectomy itself, these 166

patients had a total of 2355 encounters, which included

1494 emergency department visits and 861 hospitalisa-

tions by 149 and 144 patients, respectively. Among the

1494 emergency department visits, the 674 that

occurred postoperatively were shared across 119 (72%)

patients; among the 861 hospitalisations, 488 occurred

after colectomy and affected 110 (66%) patients. A

breakdown of the motivation for these attendances

reveals the well-described issue of ongoing abdominal

pain, which as well as other gastrointestinal symptoms

and postoperative complications, increased after colec-

tomy.

Figure 2 Forest plot showing totalcomplications (percentage of patients)

after colectomy by procedure type.

CIRA, colectomy and ileorectal

anastomosis; lap, laparoscopic; ISA,ileosigmoid anastomosis; IPCRA,

isoperistaltic caecorectal anastomosis;

APCRA, antiperistaltic caecorectal

anastomosis.




Summary evidence statements: harms

1 Data on harms were inconsistently reported and

heterogeneous in findings, thus estimates of harm are

tentative and imprecise (level IV).

2 Proportionally greater evidence for perioperative out-

comes comes from studies of colectomy and ileorec-

tal anastomosis than for other procedural variations

(CIRA: 29 studies, 1321 patients; other procedures:

10 studies, 247 patients) (level IV).

3 Total perioperative complication rates vary greatly

but may occur in approximately 20–30% of

colectomy patients. The influence of resection

extent, anastomotic configuration and method of

access on complication rates remains uncertain (level

IV).

4 Rates of post-operative ileus or early post-operative

adhesional small bowel obstruction vary greatly but

may occur in about 5–15% of patients and about one

third of these patients require re-operation (level IV).

5 Mortality rate for 39 studies reporting this outcome

was 6 / 1568 patients (0.4%) (level IV).

6 Long-term adverse events characterized by recurrent

episodes of small bowel obstruction occur in about

10–20% of patients and may result in a significant

burden of re-hospitalization and frequent recourse to

surgery in most of these patients (level IV).

7 Current evidence tentatively suggests laparoscopic

surgery may reduce some complications when

compared to open surgery, although this needs to

be confirmed by better designed studies (level IV).

Efficacy

Measurement of outcome was inconsistent, including

variable use of validated and un-validated scoring instru-

ments for symptoms e.g. Cleveland Clinic Constipation

Score or quality of life (QoL), GI quality of life, indi-

vidual symptom reporting and global ‘success’ or ‘satis-

faction’ ratings (GSR) obtained via a variety of methods

(where ‘satisfied’ or ‘very satisfied’, ‘good’, ‘very good’

and ‘excellent’ were interpreted as positive outcomes).

No study documented that data were acquired objec-

tively by using personnel not involved in the surgical

care of the patient. Only one study documented that

collection of data was blind to intervention status [20]

and this RCT only blinded observers for 4 days while

presenting follow up data to 32 months. Average

Figure 3 Forest plot showing rates of

post-operative ileus (percentage ofpatients) after colectomy by procedure

type.CIRA, colectomy and ileorectal

anastomosis; lap, laparoscopic; ISA,ileosigmoid anastomosis; IPCRA,


APCRA, antiperistaltic caecorectal

anastomosis.




reported follow-up of studies was 4.3 years (range 1–11 years).

Accepting these methodological limitations, there are

many reports supporting the assertion that most patients

undergoing colectomy are satisfied; meta-analysis of

studies found an overall global satisfaction rating of

85.6% (95%CI: 81.4–89.3%), I2 = 76.9% based on data

from 1616 patients (Table 4; Fig. 5). Again study find-

ings are heterogeneous, with no clear advantage for any

particular procedure or surgical approach. However, such

Table 3 Long-term small bowel obstruction and re-operation rates.

Author Year Operation N SBO Re-operation*

(a) Open colectomy and ileorectal anastomosis

Pemberton [26] 1991 CIRA 36 11.1 8.3

Piccirillo [27] 1995 CIRA 54 9.3 3.7

Redmond [21] 1995 CIRA 37 18.0 NR

Lubowski [29] 1996 CIRA 52 17.0 14.0

Pluta [31] 1996 CIRA 24 21.0 8.4

Ghosh [32] 1996 CIRA 21 71.0 42.0

Nyam [33] 1997 CIRA 74 9.5 6.7

Bernini [36] 1998 CIRA 106 29.0 18.0

Pikarsky [39] 2001 CIRA 62 7.3 (21.4)† 2.4 (14.3)†

Pikarsky [40] 2001 CIRA 30 20.0 10.0

Mollen [42] 2001 CIRA 21 19.0 9.5

Nylund [43] 2001 CIRA 40 42.5 42.5

Fitzharris [45] 2003 CIRA 75 38.0 17.0

Hassan [46] 2006 CIRA 65 0 0

Jiang [50] 2008 CIRA 21 15.0 NR

Sohn [53] 2011 CIRA 37 10.8 2.7

Wang [55] 2013 CIRA 68 2.9 0

Kamm [23] 1988 Mix 44 NR 38.0

Vasilevsky [24] 1988 Mix 52 36.0 24.0

Yoshioka & Keighley [25] 1989 Mix 40 NR 30.0

Platell [30] 1996 Mix 96 10.4 36.0

Hasegawa [37] 1998 Mix 61 NR 45.0

Fan [38] 2000 Mix 24 21.0 4.2

de Graaf [28] 1996 Segmental on transit 42 2.0 2.0

You [35] 1998 Segmental on transit 40 NR 7.5

Lundin [44] 2002 Segmental on transit 28 19.2 25.0

Feng [22] 2008 IPCRA 34 8.9 NR

Feng [22] 2008 ISA 45 6.7 NR

Jiang [50] 2008 APCRA 17 11.8 NR

Marchesi [54] 2012 APCRA 15 13.3 13.3

(b) Series including open and laparoscopic procedures

Marchesi [47] 2007 APCRA 23 5.9 11.8

Zutshi [48] 2007 CIRA 69 20.0 11.6

Riss [52] 2009 CIRA 20 65.0 45.0

Reshef [56] 2013 CIRA 144 NR 20.0

Dudekula [19] 2015 CIRA 56 NR 30 additional surgeries

in 12 months F up

(c) Laparoscopic procedures only

Pinedo [51] 2009 APCRA 20 5.0 5.0

Marchesi [54] 2012 APCRA 15 6.7 0

Wang [55] 2013 CIRA 56 0 0

SBO, small bowel obstruction; NR, not reported.

*Includes all reported for bowel complications although majority are for adhesional SBO.†(Values) for age 65–85 years.




levels of satisfaction can be related to marked changes in

bowel frequency (generally from a mean of once per week

to three times per day in the 14 studies reporting both

variables) (Table 5), and where recorded (three studies

only), marked changes in summative symptom scores e.g.

the Cleveland Clinic Constipation score reduced from a

mean of > 20 points pre-operatively (indicative of severe

constipation) to approx. 2–3 points (low normal range)

post-operatively. Individual symptom outcomes high-

lighted the well documented problems of diarrhoea: 9.8%

(95%CI: 4.7–16.4%), I2 = 76.9% (Fig. 6); and inconti-

nence: 7.4%, (95%CI: 2.2–14.7%), I2 = 90.8% following

colectomy, ongoing or recurrent constipation: 18.2%,

(95%CI: 9.3–29.2%), I2 = 91.4%; persistent (or wors-

ened) abdominal pain: 39.3%, (95%CI: 28.8–50.1%),I2 = 89.0%; and bloating 23.9%, (95%CI: 11.9–38.1%),I2 = 92.7%. Poor functional outcomes contributed to

further resection or permanent stoma: median 5% (range

0–28%) patients when reported (by only seven studies;

data not shown).

Meta-analyses of efficacy outcomes featured consider-

able heterogeneity, not explained by procedure or age

of publication. Given the different duration of studies

and variable follow up within studies there is also the

potential for time-confounding. Studies limited only to

laparoscopic procedures are characterized by small num-

bers limiting scope for comparison with open proce-

dures and no adjustment has been attempted for

potential differences in the populations recruited into

individual studies. Consequently efficacy estimates are

tentative.

Accepting the caveat that only a minority of studies

reported functional variables, several observations can

be made regarding functional outcomes in studies of

less radical colonic resections (Tables 5b and c) com-

pared to those for CIRA (Table 5a). The general pre-

mise of such procedures is to reduce the risk of long-

term diarrhoea and incontinence and this concept is in

part supported by data that, accepting small study num-

bers and heterogeneity, suggest potential to reduce

rates of diarrhoea for segmental and subtotal resections

(Fig. 6). However, this was at the cost of increased

ongoing or recurrent constipation (median 8.7% for

CIRA compared to 26.8% for more conservative

Figure 4 Forest plot showing (a) long-term rates of small bowel obstruction

(percentage of patients) after colectomy

by procedure type with focus on openand laparoscopic approach; (b) rates of

re-operation for small bowel obstruction

(percentage of patients) after colectomy

by procedure type. CIRA, colectomy andileorectal anastomosis; lap, laparoscopic.




resections). The latter has proved a particular problem

for segmental resections (right or left hemicolectomy)

with generally poor results compared to colectomy

mainly due to unresolved constipation requiring further

intervention (Table 5c). De Graaf et al. [28] used seg-

mental transit (radio-opaque marker) methodology to

select patients for partial left sided colectomy or subto-

tal colectomy. Whilst results as a whole were disappoint-

ing, the study concluded that in terms of complications

and functional outcome, there was little difference

between procedures, and that a more limited resection

was therefore a reasonable option in this selected group.

You et al. [35] reported the use of left, right or subto-

tal colectomy based on segmental transit time measure-

ments with excellent results. Further, in the three cases

where constipation recurred following segmental resec-

tion, a subtotal colectomy was undertaken successfully

at a later date. This experience was not however

repeated by Lundin et al., [44] when recurrent consti-

pation was experienced by 46% patients despite transit-

guided resection. Thus, while in the laparoscopic era

where there is a greater theoretical advantage of not

meeting the technical challenges of mobilizing both

colonic flexures laparoscopically, the tailoring of seg-

mental resections using these specialist investigations of

transit is inconsistently supported by published data.

Further, the tests required to accurately determine

resection level e.g. isotope scintigraphy have limited

availability.

Subtotal resection with ileosigmoid anastomosis is

generally considered less effective than ileorectal anasto-

mosis based on several relatively small case series mixing

both procedures (Table 4d). Contemporary data on

subtotal resections with CRA come mainly from a few

institutions in Italy and China. Conclusions from these

studies vary. For example, Li et al. [57] demonstrated

good results for both isoperistaltic CRA and CIRA. Feng

et al. [22] compared isoperistaltic CRA with SCISA. Sur-

gical safety outcomes and length of stay were similar but

patients were more satisfied after ileosigmoid anastomo-

sis mainly due to ongoing constipation in caecorectal

group. However patients experienced slightly less

Figure 4 Continued




Table 4 Percentage success based on global satisfaction ratings (GSR).

Author Year FU (mean) Operation N % success

(a) Colectomy and ileorectal anastomosis

Pemberton [26] 1991 36 Open 36 100

Piccirillo [27] 1995 27 Open +/� rectopexy 54 94

Redmond [21] 1995 90 Open 34 90*

Lubowski [29] 1996 42 Open 52 90

Pluta [31] 1996 65 Open 24 92

Nyam [33] 1997 56 Open 74 97

Ho [34] 1997 24 Open 17 96

Ho [34] 1997 24 Laparoscopic 7 100

Bernini [36] 1998 78 Open 106 78†

Fan [38] 2000 23 Open‡ 24 88

Pikarsky [40] 2001 60 Open 30 100

Webster & Dayton [41] 2001 12 Open (5 ileostomy) 55 89

Mollen [42] 2001 62 Open 21 76

Nylund [43] 2001 132 Open 40 73

Fitzharris [45] 2003 47 Open 75 69

Hassan [46] 2006 68 Open 65 85

Zutshi [48] 2007 130 Open & laparoscopic (n = 7) 69 79

Jiang [50] 2008 48 Open 21 65

Hsiao [49] 2008 12 Laparoscopic 44 89

Sohn [53] 2011 41 Open 37 84

Reshef [56] 2013 43 Open & laparoscopic (n = 7) 144 89§

Li [57] 2014 64 Open 40 93

(b) Subtotal colectomy and ileosigmoid anastomosis (ISA); isoperistaltic caecorectal anastomosis (IPCRA);

antiperistaltic caecorectal anastomosis (APCRA); lap: laparoscopic

de Graaf [28] 1996 46 ISA 24 67

Feng [22] 2008 47 ISA 45 93

Marchesi [47] 2007 72 APCRA (lap n = 5) 17 88

Jiang [50] 2008 48 APCRA 17 88

Feng [22] 2008 47 IPCRA 34 74

Li [57] 2014 33 IPCRA 32 97

(c) Segmental colectomy (all based on regional transit measurement)

de Graaf [28] 1996 46 Lt hemicolectomy 18 62.5

You [35] 1998 24 Segmental based on transit 40 92

Lundin [44] 2002 50 Segmental based on transit¶ 28 86

(d) Mixed procedures

Kamm [23] 1988 > 12 CIRA / IPCRA (11) 44 50

Vasilevsky [24] 1988 46 CIRA (5) / ISA 51 79

Yoshioka & Keighley [25] 1989 36 CIRA / ISA (1) / IPCRA (5) 40 58

Platell [30] 1996 60 CIRA / IPCRA (10) 96 81.3

Hasegawa [37] 1999 84 CIRA, ISA, IPCRA, segmental 61 39–95**

FU, mean follow up in months; NR, not reported.

*12.5% with generalized intestinal disorder (see text).†56% with associated rectal evacuatory disorder.‡2 patients had caecorectal anastomosis.§85% with associated rectal evacuatory disorder.¶26 of 28 had left hemicolectomy (6 with rectopexy) and 2 right.

**Outcome dependent on psychiatric disease and concomitant rectal evacuation disorder.




diarrhoea and incontinence after caecorectal anastomosis.

Jiang et al. [50] compared antiperistaltic CRA with ileo-

rectal anastomosis. Again there were no differences in

post-operative course, however patients undergoing

caecorectal anastomosis had less diarrhoea, higher post-

operative quality of life (not recorded pre-operatively)

and overall reported GSR (88 vs 65%).

Laparoscopic surgery has the theoretical advantages

of better cosmesis (especially in young women) and per-

haps lower long-term complication rates (see above).

Such factors have not however yet translated into

improved functional outcomes mainly because these

have not yet been the focus of comparative studies. Ho

et al. [34] found no difference in GSR between open

and laparoscopic CIRA (96 vs 100%). In the case-con-

trol study of Marchesi et al. [54], despite the halving of

SBO rates (from 13.3 to 6.7%) in the laparoscopic

groups, long-term functional outcomes and GI quality

of life were very similar.

Summary evidence statements: efficacy

1 Proportionally greater evidence for efficacy comes

from studies of colectomy and ileorectal anastomosis

than for other procedural variations (CIRA: 25 stud-

ies, 1209 patients; mixed: 5 studies, 280 patients;

other procedures: 9 studies, 247 patients; and seg-

mental procedures 4 studies, 99 patients (level IV).

Figure 5 Forest plot showing global

success rates as defined by percentage of

patients who were ‘satisfied’ or ‘verysatisfied’ with outcome, or where

outcome was defined as ‘good’ or

‘excellent’ after colectomy by procedure

type. CIRA, colectomy and ileorectalanastomosis; lap, laparoscopic; ISA,

ileosigmoid anastomosis; IPCRA,


APCRA, antiperistaltic caecorectalanastomosis; mixed, mix of resection

types reported in each case series.




Table

5Functional

outcomes

byprocedure.

Author

Year

Procedure

NBFpre

BFpost

CCSpre

CCSpost

DI

AP

LB

RC

(a)Colectomyandileo

rectal

anastomosis

Pem

berton[26]

1991

Open

36

NR

14.0

NR

NR

00

NR

00

0

Red

mond[21]

1995

Open

37

NR

26/5*

NR

NR

NR

NR

0/69*

0/44*

0/44*

NR

Piccirillo[27]

1995

Open

†54

NR

26

NR

NR

24

24

NR

1.9

NR

NR

Lubowski[29]

1996

Open

52

NR

28.0

NR

NR

14

12

52

NR

NR

26.9

Pluta

[31]

1996

Open

24

1.4

18.0

NR

NR

33

NR

58

NR

29

NR

Ghosh

[32]

1996

Open

‡21

NR

NR

NR

NR

NR

NR

90

NR

NR

NR

Nyam

[33]

1997

Open

74

NR

28

§14

NR

NR

<10

1NR

2§9

NR

0

Ho[34]

1997

Open

17

0.3

11.2

17115.4

NR

NR

00

NR

00

0

Bernini[36]

1998

Open

90

NR

19.6

§14.6

DD

NR

NR

14

§15

21

§20

44

§37

NR

45

§43

4§38

Fan

[38]

2000

Open

24

1.4

22.8

NR

NR

8.3

0NR

8.3**

NR

8.3**

Pikarsky[39]

2001

Open

62

1.4

††1.0

20.3

††26.6

NR

NA

9††27

17

††36

NR

0††9

NR

NR

Pikarsky[40]

2001

Open

30

NR

17.5

NR

NR

NR

17

NR

623

NR

Web

ster

&Dayton[41]

2001

Open

‡‡

55

NR

21.0

NR

NR

54

19

NR

10

9

Mollen

[42]

2001

Open

21

0.8

19.6

NR

NR

NR

10

86

62

90

76

Nylund[43]

2001

Open

40

1.1

3.8

NR

NR

NR

7.5

38

NR

NR

NR

Fitzh

arris[45]

2003

Open

75

NR

2.5

NR

NR

25

45

41

20

NR

NR

Zutshi[30]

2007

Open

&lap

69

1.0

21.0

NR

NR

NR

NR

37

NR

66

51

Jiang[50]

2008

Open

21

1.4

23.8

NR

NR

15

NR

20

NR

25

NR

Pined

o[51]

2009

Lap

20

NR

NR

22.3

1.8

NR

NR

5NR

NR

5

Riss[52]

2009

Open

orlap

20

NR

NR

NR

11.5

§§

NR

NR

NR

NR

NR

50§§

Sohn[53]

2011

Open

37

NR

NR

19.3

2.1

NR

NR

NR

NR

NR

NR

Xu[20]

2012

Open

32

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Wang[55]

2013

Open

orlap

114

NR

35.0

NR

NR

NR

NR

NR

6NR

6

Reshef

[56]

2013

Open

orlap

144

NR

31.0

(33.0)

NR

NR

NR

11(15)

31(33)

13(26)

NR

NR

Li[57]

2014

Open

40

NR

NR

27.3

NR

2.5

2.5

13

NR

7.5

NR

(b)Subtotalcolectomyandileo

sigmoid

anastomosis(ISA);isoperistaltic

caecorectal

anastomosis(IPCRA);andantiperistaltic

caecorectal

anastomosis(A

PCRA);lap:laparoscopic

deGraaf

[28]

1996

ISA

24

NR

NR

NR

NR

12.5

8.3

62.5

20.8

50

29.2

Fen

g[22]

2008

ISA

45

1.6

15.5

NR

NR

4.5

2.2

17.8

6.7

15.6

6.7

Sun[58]

2015

ISA

22

1.1

34.3

NR

5NR

NR

NR

NR

NR

NR

Marchesi[47]

2007

APCRA

17

NR

19.6

20.3

2.6

NR

NR

NR

NR

NR

NR

Fen

g[22]

2008

IPCRA

34

1.5

10.2

NR

NR

NR

024

26.8

24

26.8

Jiang[50]

2008

APCRA

17

1.5

16.8

NR

NR

0NR

NR

NR

23.5

NR

Marchesi[54]

2012

APCRA

30

NR

18.2

20

3NR

NR

NR

NR

NR

NR

Li[57]

2014

IPCCRA

32

NR

NR

27

NR

3.1

03.1

NR

3.1

NR




Table

5(C

ontinued

).

Author

Year

Procedure

NBFpre

BFpost

CCSpre

CCSpost

DI

AP

LB

RC

Sun[58]

2015

IPCCRA

26

1.1

16.1

NR

3.2

NR

NR

NR

NR

NR

NR

(c)Segmen

talcolectomy

deGraaf

[28]

1996

Lthem

icolectomyontransit

18

NR

NR

NR

NR

5.6

5.6

33.3

16.7

22.2

16.7

You[35]

1998

Segmen

talontransit

40

114

NR

NR

0NR

NR

NR

08

Hasegaw

a[37]

1999

Segmen

talmix

13

NR

NR

NR

NR

NR

NR

NR

NR

NR

62

Lundin

[44]

2002

Predom.lefthem

iontransit

28

17

NR

NR

NR

NR

50

067

46

(d)Mixed

procedures

Kam

m[23]

1988

IRA

/APCRA

44

NR

NR

NR

NR

39

14

71

45

45

11

Vasilevsky[24]

1988

IRA

/ISA

(predom)

52

NR

19.6

NR

NR

NR

2NR

20

NR

NR

Yoshioka&

Keighley[25]

1989

IRA

/ISA

/IPCRA

40

0.3

21.0

NR

NR

33

NR

39

NR

NR

NR

Platell[30]

1996

IRA

/IPCRA

96

NR

NR

NR

NR

NR

52

55

NR

NR

NR

Hasegaw

a[37]

1999

IRA,ISA,IPCRA

48

NR

NR

NR

NR

NR

NR

NR

NR

NR

33

NR,notreported

;BF,Bowel

freq

uen

cy/week;

CCS,ClevelandClinic

Constipationscore;D,diarrhoea;I,

incontinen

ce;AP,abdominal

pain;L,laxatives;

B,bloating;RC,recurren

t

constipation.

*If

associated

gen

eralized

intestinal

disorder

(GID

).†5withrectopexy.

‡Includes

onesegmen

talresection.

§Values

ifSTC

associated

withconcomitantRED;values

forlaparoscopic

wherethesediffered.

**In

2/24patients

undergoingcaecorectal

anastomosis.

††Age65–8

0(compared

to21–6

1years).

‡‡Includes

oneen

dileo

stomy.

§§Based

on12patients

infollow

up.

Studiesnotreportingacohort

average,

i.e.

only

subgroupswereexcluded

from

themeta-analysis.




2 Data on efficacy were inconsistently reported and

heterogeneous in findings, thus estimates were tenta-

tive and imprecise. Studies varied in their follow-up

of patients, the mean follow-up in studies was

4.3 years (range 1–11 years) (level IV).

3 Colectomy (based on the global rating of success)

benefits the majority of patients with slow transit

constipation: overall mean 85.6% (95% CI: 81.4–89.3%) at > 12 months follow up (level IV).

4 Negative long term functional outcomes persist in a

minority of patients: diarrhoea and incontinence in

about 5–15% of patients; abdominal pain in 30–50%of patients; recurrent constipation in 10–30% of

patients and bloating in 10–40% (level IV).

5 Tailoring of segmental resections using specialist

regional transit measurements provides uncertain

benefit (level IV).

6 There are insufficient data to conclude: (a) that alter-

native procedures (subtotal or segmental) perform

better than CIRA; (b) that one type of subtotal

resection (caecorectal vs ileosigmoid) or anastomosis

(iso- or anti-peristaltic) is superior to another; (c)

that laparoscopic approach has benefit over open sur-

gery (level IV).

7 Subtotal colectomy may reduce long-term rates of

diarrhoea compared to CIRA although this finding is

tentative and should be verified with better designed

studies (level IV).

Patient selection

While clinical experience suggests careful patient selec-

tion for procedures is important, few studies systemati-

cally addressed this issue [12]. Main findings from

studies that stratified outcomes based on baseline phe-

notype are included in Table 6. These studies provide

some information on clinical characteristics but more so

on results of specialist physiological testing.

Pikarsky et al. [39] studied whether colectomy can

be performed in elderly patients (defined 65–80 years in

their series). Although overall success was diminished

on the older age group (64% vs 95%, P = 0.01), the

authors concluded that the results were acceptable and

that the procedure was safe based on no increase in

observed morbidity. The question of whether the pres-

ence of severe psychological problems adversely influ-

ences outcome has been discussed by studies that noted

both poor outcomes and a number of post-operative

psychological problems including suicide [23]. Others

have made post-hoc correlations between prior psychi-

atric disease and poor outcome [31]. This factor was only

addressed as a stated aim by Hasegawa et al. [37], who


long-term diarrhoea (percentage of

patients) after colectomy by procedure

type. CIRA, colectomy and ileorectalanastomosis; lap, laparoscopic; ISA,

ileosigmoid anastomosis; IPCRA,

isoperistaltic caecorectal anastomosis;APCRA, antiperistaltic caecorectal

anastomosis; mixed, mix of resection

types reported in each case series.




Table

6Summaryofprognostic

findings.

Author

Year

Factorstudied

Op

NFU

Mainfindings:

perioperative

Mainfindings:functional

Mainfindings:long-

term

morbidity

Red

mond[21]

1995

GID

CIR

A34

90

Increasedperioperative

morbidity(44%vs

24%)withGID

and

increasedLOS:13.1

vs

12.1

days

GRA

12.5%vs

90%satisfied

withoutcomein

GID

group;

at2years:BH

5vs

28p.w,rec.

constipation&

pain56%

inGID

vs5%in

noGID

group.Sim

ilar

findingsfor

bloating,abdominal

painandlaxative

requirem

ents

at

2yearsandworseat

5years

1death

inboth

groups:

GID

secondaryto

TPN

catheter

Nyam

[33]

1997

RED

CIR

A74

56

NR

Resultssimilar

(nos.d)betweenRED

andnoRED

forall

studied

NR

Hasegaw

a[37]

1999

RED

&psych

Mix

61

84

NR

Failure

in11%withoutvs

39%withRED;failure

in70%

withpsychological

problems(incs-fold

increase

in

admissions,further

surgery,

and5fold

increase

in

even

tual

stoma

Bernini[36]

1998

RED

CIR

A106

78

NR

GRA

decreased

ifRED:56vs

78%;weeklyBF14.7

vs

19.6;nodiffin

other

symptoms

SBO

only

inCIgroup-

23vs

0%

Pikarsky[39]

2001

Age<or>65years

CIR

A59

105

SBO

21%in

ageover

65vs

7%in

younger

patientgroup

WeeklyBFhigher

(n.s)in

older

group(26.6

vs20.3);

excellen

toutcomein

64%older

vs95%;increasedFIin

older

(36%vs

17%)

1/14older

group

required

stoma

Hassan[46]

2006

RED

CIR

A104

68

NR

Nodiffin

KESSandSF-12withorwithoutRED

Reshef

[56]

2013

RED

CIR

A144

43

LOSlonger

withRED

9.7

vs7.8

days;overall

morbidityotherwise

similar

61vs

54%POI;

re-operation41vs

26%

Inc.

laxuse

inRED

group(26vs

13%)other

variables

similar

inc.

overallsatisfaction:GRA

89vs

85

Nodiffin

ileo

stomy

rates(5%both

groups)

orre-admissions(30%

both

groups)

RED,rectal

evacuation

disorder;GID

,gen

eralized

intestinal

disorder;BF,biofeed

back;

CIR

A,colectomyand

ileo

rectal

anastomosis;

KESS,Knowles-Eccesley-Scott

score;LOS,

length

ofstay.




reported a statistically significant prejudicial influence of

‘severe psychological disorder’.

Outcomes of colectomy are improved by selection of

patients with proof of slow colonic transit. Although it

could be argued that other factors may have also influ-

enced outcomes (e.g. mix of surgical approaches, surgi-

cal technique and equipment), this statement is

corroborated by comparing outcome data from an era

when specialist investigations of transit were variably

applied [23–25,37] with subsequent studies that always

performed transit studies and used these as a selection

criteria. Most contemporary studies also evaluated

anorectal physiology especially in relation to the diagno-

sis of a combined slow-transit and defaecatory disorder

phenotype. The management of this patient group

remains contentious. Bernini et al. [36] in a study of

106 patients demonstrated that despite preoperative

biofeedback training, patients with non-relaxing pelvic

floor (n = 16) had significantly higher rates of recurrent

defaecatory difficulty (38 vs 4%), and lower rates of sat-

isfaction after colectomy (56 vs 78%). However, three

other studies (Table 6) found little effect on functional

outcome or complication rates when functional or

structural defects were addressed prior to colectomy.

These studies included the contemporary Cleveland

Clinic experience of 144 patients where obstructed

defaecation (n = 41) had no influence on outcome from

laparoscopic or open colectomy [56].

It is generally accepted that some patients with slow

colonic transit also manifest upper GI symptoms (espe-

cially nausea and vomiting). Abnormalities of oesopha-

geal, gastric and small bowel function can be

demonstrated in a proportion of patients by a variety of

methods [18]. Ghosh et al. [32] showed that the high

proportion of patients undergoing colectomy who sub-

sequently developed SBO episodes (71% with 42%

requiring surgery in their series) were more likely to

have non-colonic visceral and autonomic nervous system

abnormalities on post-operative testing. This observa-

tion has been considerably strengthened by the prospec-

tive cohort study of Redmond et al. [21]. A significant

fall in long-term success rate (to 10 years) as a result of

persistent constipation, abdominal pain and distension)

was observed in patients defined as having a generalized

intestinal disorder (GID) on the basis of having both

upper and lower GI dysmotility using a battery of intra-

luminal tests. Successful outcome was observed in only

12.5% patients with GID vs 90%: without.

Summary evidence statements: patient selection

1 Outcomes of colectomy may be poorer in patients

with significant psychological disorder (level IV).

2 Outcomes of colectomy may be improved by selec-

tion of patients with definitive proof of slow colonic

transit (level IV).

3 Outcomes of colectomy are inconsistently influenced

by concomitant rectal evacuation disorder although

data suggest that structural and functional defecation

disorders, if evident, should be treated prior to colec-

tomy (level IV).

4 Outcomes of colectomy may be prejudiced by pre-

operative evidence of upper gastrointestinal dysmotil-

ity (level IV).

Conclusions

A systematic review of evidence for the perioperative

and long-term benefits and harms of colectomy identi-

fied no high quality studies. The evidence base is char-

acterised by observational studies of variable and often

uncertain methodological quality. Current data suggest

a balance of harms against efficacy with evidence that

outcomes are at best variable. Future studies should

provide high quality evidence for clinicians to support

patient decision making, both in terms of the incremen-

tal benefits and harms of colectomy and in understand-

ing the effects of prognostic factors upon treatment

success.

Acknowledgments


relation to the NIHR CapaCiTY working group: Mr

Steven Brown, Sheffield Teaching Hospitals NHS

Foundation Trust; Mr Kenneth Campbell, The Univer-

sity of Dundee, NHS Education for Scotland; Mr Mark

Chapman, Heart of England NHS Trust; Mr Andrew

Clarke, Poole Hospital NHS Foundation Trust; Mr Neil

Cruickshank, Sandwell and West Birmingham Hospitals

NHS Trust; Mr Anthony Dixon, University of Bristol,

Bristol, UK; Dr Christopher Emmett, County Durham

and Darlington NHS Foundation Trust; Mr Ugo

Grossi, Queen Mary University of London; Dr Richard

Hooper, PCTU, Queen Mary University of London;

Miss Emma Horrocks, University Hospital Southamp-

ton NHS Foundation Trust; Professor Charles Knowles,

Queen Mary University of London; Mr Jon Lacy-Col-

son, Shrewsbury and Telford Hospital NHS Trust; Mr

Ian Lindsey, Oxford University Hospitals NHS Trust;

Professor James Mason, University of Warwick, Coven-

try; Mr Mark Mercer-Jones, Gateshead Health NHS

Foundation Trust; Mr Andrew Miller, University

Hospitals of Leicester NHS Trust; Mr David Pares,

Hospital Germans Trias i Pujol, Barcelona, Spain; Miss

Sophie Pilkington, University Hospital Southampton




NHS Foundation Trust; Mr Neil Smart, Royal Devon

& Exeter NHS Foundation Trust; Ms Natasha Stevens,

PCTU, Queen Mary University of London; Professor

Douglas Tincello, University Hospitals of Leicester

NHS Trust; Miss Karen Telford, South Manchester

NHS Foundation Trust; Mr Paul Vollebregt, Queen

Mary University of London; Mr Andrew Williams,

Guy’s and Thomas’ NHS Foundation Trust; Professor

Yan Yiannakou, County Durham and Darlington NHS

Foundation Trust.

Conflict of interest

All authors have no conflict of interest in relation to the

content of the manuscript. In the last 2 years, C.H.

Knowles has received speaker fees and consultancy pay-

ments from Medtronic Inc. Mark Chapman has received

funding to attend courses from Medtronic Inc.

Funding



Research (RP-PG-0612-20001). The views and opinions

expressed in this report are those of the authors and are not

those of the PGfAR Programme, NIHR, the UK National

Health Service, or the UKDepartment of Health.

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Results II: Hitching procedures for the rectum (rectal suspension)

U. Grossi*, C. H. Knowles*, J. Mason†, J. Lacy-Colson‡ and S. R. Brown§ on behalf of the NIHR

CapaCiTY working group¶ and Pelvic floor Society**

*National Bowel Research Centre, Blizard Institute, Queen Mary University London, London, UK, †University of Warwick, Coventry, UK, ‡RoyalShrewsbury Hospital, Shrewsbury, UK, §Sheffield Teaching Hospitals, Sheffield, UK, ¶National Institute for Health Research: Chronic Constipation

Treatment Pathway, London, UK, and **Affiliate section of the Association of Coloproctology of Great Britain and Ireland, London, UK

Abstract

Aim To assess the outcomes of rectal suspension proce-

dures (forms of rectopexy) in adults with chronic con-

stipation.





with a summative Oxford Centre for Evidence-Based

Medicine (2009) level.

Results Eighteen articles were identified, providing data

on outcomes in 1238 patients. All studies reported only

on laparoscopic approaches. Length of procedures ran-

ged between 1.5 to 3.5 h, and length of stay between 4

to 5 days. Data on harms were inconsistently reported

and heterogeneous, making estimates of harm tentative

and imprecise. Morbidity rates ranged between 5–15%,with mesh complications accounting for 0.5% of

patients overall. No mortality was reported after any

procedures in a total of 1044 patients. Although

inconsistently reported, good or satisfactory outcome

occurred in 83% (74–91%) of patients; 86% (20–97%)of patients reported improvements in constipation after

laparoscopic ventral mesh rectopexy (LVMR). About 2–7% of patients developed anatomical recurrence. Patient

selection was inconsistently documented. As most com-

mon indication, high grade rectal intussusception was

corrected in 80–100% of cases after robotic or LVMR.

Healing of prolapse-associated solitary rectal ulcer syn-

drome occurred in around 80% of patients after LVMR.

Conclusion Evidence supporting rectal suspension pro-

cedures is currently derived from poor quality studies.

Methodologically robust trials are needed to inform

future clinical decision making.

Keywords Rectopexy, chronic constipation, laparo-

scopic ventral mesh rectopexy (LVMR), robotic ventral

mesh rectopexy (RVMR), laparoscopic resection recto-

pexy (LRR), open rectopexy (OR)

Introduction


Constipation, in a proportion of patients and in the broad

sense of the term, is related to an inability to evacuate the

rectum. This obstructed defaecation or rectal evacuation

disorder is characterized by excessive straining, the feeling

of incomplete evacuation, post-defaecatory seepage and

often mucous discharge and pelvic pain [1]. In some of

these patients there is clinical and proctographic evidence

of a rectocoele and/or intussusception. These anatomical

variants are considered to cause obstructed defaecation by

a process of loss of force vector (ballooning of the rectum

into a rectocoele or invagination of the rectum into an

intussusception rather than evacuation of stool on strain-

ing) or mucosal obstruction (in the case of an intussus-

ception) [1]. It follows that clinical resolution of

symptoms could be achieved by restoration of normal

anatomy by surgery. Resuspension of the rectum aims to

hitch the prolapsing or redundant rectal wall thus

straightening the intussusception and/or effacing the rec-

tocoele. This concept while anatomically rational remains

clinically controversial for a number of reasons. First, such

anatomical variants are common and are often found in

healthy individuals with no symptoms of obstructed

defaecation [2]. Secondly, resuspension operations when

employed to patients with full thickness rectal prolapse,

Correspondence to: Mr Steven Brown, Consultant Colorectal and General

Surgeon, Department of Surgery, Northern General Hospital, Herries Road,

Sheffield S5 7AU, UK.








may themselves cause increasing constipatory symptoms

[3]. Such procedures include posterior rectopexy [4].

The potential for worsening constipation is thought to

relate to fibrosis caused by insertion of foreign material or

mobilization of the lateral ligaments of the rectum. These

ligaments contain nerves to the rectal wall and the resul-

tant denervation may be the cause. In the process of

developing alternative resuspending procedures, surgeons

have attempted to limit the effect of the foreign material

by using sutures only [5], added a resection of the sig-

moid colon to the rectopexy [6–8] or more recently, lim-

iting the dissection of the rectum to the ventral surface by

supporting the rectum with mesh [9–23]. In addition,

laparoscopy has become the favoured approach procedu-

rally, not only allowing a more rapid recovery but also

easing access to, and visibility in the pelvis.

Scope

The purpose of the overall CapaCiTY review process is to

assess the efficacy and harms of surgical procedures for

chronic constipation in adults. Thus, the aim of this

review is to assess the outcomes of rectal suspension pro-

cedures in adults presenting with chronic constipation

symptoms. In effect, this is however limited to patients

with obstructed defaecation and internal prolapse (intus-

susception). Procedures considered beyond the scope of

systematic review included rectal excisional procedures,

e.g. STARR [9], rectal reinforcement procedures, e.g.

transanal/transperineal repair of rectocele [10], and

uncommon variant of suspension procedures, e.g. laparo-

scopic promonto-fixation [11]. Studies where outcomes

could not be segregated by eligible procedure were also

excluded due to a mixed patient population with internal

and external rectal prolapse [12–19], mixed indications

including numerous pelvic floor abnormalities [20] or

limited postoperative outcomes [21].

Previous reviews

Seven systematic [3, 22–27] and 4 narrative [28–31]reviews have focused on the outcome of rectal suspen-

sion. Of the systematic reviews, 3 [3,23,26] focused on

full thickness external rectal prolapse, 2 included both

full-thickness prolapse and constipation participants, and

2 [22,25] analysed outcomes of robotic surgery.


The search yielded a total of 47 manuscripts for full text

review (Fig. 1). From these, 18 articles published

between 1995 and 2015 contributed to the systematic

review, providing data on outcomes in a total of 1238

patients (range 20–233 patients per study) based on 18

defined patient cohorts (Table 1). Specific exclusions

after full-text review (and after exclusion of non-English

language publications) included 4 studies where the pop-

ulation sample was confirmed to be less than 20 patients

[5,36–38], 4 studies of out-of-scope procedures [9–11,39], 2 studies where data were considered a duplicate

Figure 1 PRISMA diagram of search results.



Rectal suspension for constipation U. Grossi et al.

[34,40], and 10 studies where outcomes could not be

segregated by eligible procedure; [12–21] other exclusioncriteria were: constipation not representing an indication

(n = 2) [32,41], follow-up less than 12 months (n = 5)

[8,33,35,42,43], and lack of primary patient data (one

international survey on 391 surgeons) [44].


quate description of methods. The 18 included studies

were all observational with no randomised controlled

trials. These comprised two good quality prospective

cohort studies [45,46] (level IIB), and 16 (level IV)

studies comprising two poor quality case-control studies

[34,47], eight prospective case series [6,7,48–53], andsix retrospective case series [4,54–58]. Mean patient fol-

low-up ranged from 12 to 72 months (median

25 months). Fifteen studies derived from European

centres, with one each from Australia, Iran and Japan.

Perioperative data

Perioperative data were reported by all 18 studies

(Table 2). Reporting of procedure duration was incon-

sistent but median procedural duration for laparoscopic

ventral mesh rectopexy (LVMR) was 159 (range 75–198) min; for robotic ventral mesh rectopexy (RVMR),

205 (range 191–218) min; for laparoscopic resection

rectopexy (LRR), 123 min (one study) [45,46].

Although robotic procedures appeared to take longer,

substantial non-reporting of other procedures

precluded a clear finding. The two papers on RVMR

were from the same centre. It is interesting to note a

decrease in duration of operation, which may indicate a

learning curve. Conversion to laparotomy was rare (me-

dian 2%, range 0–8%) (Table 2), with the most com-

mon reason being adhesions. The median length of

stay (LOS) was similar for procedures: LVMR, median

3.3 (range 1.0–7.1) days; RVMR, median 4.3 (range

4.0–4.6) days (data from one centre via two reports)

[45,46]; LRR, 4 days (data from one study) [7]. LOS

possibly reflected local policy rather than clinical need,

since day case procedures have been shown to be feasi-

ble [59,60]. The reason to keep patients in hospital for

up to 1 week was not documented. Only one paper

commented on LOS after open rectopexy (OR)

(8.5 days) [54].


1 Procedures are reported to take from 1.5 to 3.5 h,

with consequent typical LOS of 4–5 days (level IV).

2 There was no clear variation between procedures in

perioperative measures, although non-reporting by

studies may have concealed differences (level IV).

Harms

There was a considerable heterogeneity in surgical

morbidity reported as well as in overall procedural



van Tets[4] 1995 Groot Netherlands 37 72 RCS IV

Tsiaoussis [6] 2005 Heraklion Greece 27 45 PCH IV

Vermeulen [54] 2005 Rotterdam Netherlands 20 18 RCS IV

Von Papen [7] 2006 Herston Australia 56 44 PCS IV

Collinson [48] 2009 Oxford UK 75 12 PCS IV

Kargar [55] 2011 Shaid Sadoughi Iran 39 32 RCS IV

Portier [49] 2011 Toulouse France 40 22 PCS IV

Wong [45] 2011 Nantes France 41 12 PCH IIB

Wong [50] 2011 Nantes France 84 29 PCH IV

Sileri [51] 2012 Rome Italy 34 12 PCS IV

Wahed [52] 2012 Gateshead UK 65 12 PCS IV

Evans [34] 2013 Oxford UK 30 36 PCS IV

Formijne Jonkers [56] 2013 Amersfoort Netherlands 233 30 RCS IV

Gosselink [57] 2013 Oxford UK 151 12 RCS IV

Mantoo [46] 2013 Nantes France 128 16 PCH IIB

Borie [58] 2014 Montpellier France 52 18 RCS IV

Franceschilli [53] 2015 Rome Italy 100 20 PCS IV

Tsunoda [47] 2015 Kamogawa City Japan 26 16 PCS IV

PCH, prospective cohort study; RCS, retrospective case series; PCS, prospective case series study.

*Mean follow up in months.

†Oxford CEBM [34]. A median time follow up time was not provided.



U. Grossi et al. Rectal suspension for constipation

Table

2Perioperativedatabyprocedure.(a)Laparoscopic

ventral

meshrectopexy(L

VMR).(b)Roboticventral

meshrectopexy(R

VMR).(c)Laparoscopic

resectionrectopexy

(LRR).(d)Open

rectopexy(O

R).

(a)

Author

Year

N

Duration,

mins

LOS

Totalcx,%

Re-op,%

Mesh

comps,%

Conv,%

Stoma,

%Mort,%

Collinson[48]

2009

75

NR

24

00

1.3

00

Kargar

[55]

2011

39

NR

NR

NR

NR

NR

NR

NR

NR

Portier[49]

2011

17(40*)

NR

NR

7.5

00

NR

00

Wong[45]

2011

25

159

4.6

NR

00

80

0

Wong[50]

2011

84

NR

58.3

1.2

1.2

3.6

00

Sileri[51]

2012

34

110

223.5

2.9

00

00

Wahed

[52]

2012

65

NR

27.6

1.5

01.5

00

Form

ijneJonkers

[56]

2013

233

NR

54.7

0.4

0.9

2.5

0.4

0

Gosselink[57]

2013

151

NR

NR

NR

NR

NR

NR

NR

NR

Mantoo[46]

2013

74

163

511

00

40

0

Borie[58]

2014

25

NR

7.1

24

0NR

80

0

Evans[34]

2015

30

NR

NR

10

03.4

NR

00

Franceschilli[53]

2015

100

75

216

10

10

0

Tsunoda[47]

2015

26

198

17.6

00

00

0

(b)

Wong[45]

2011

16

218

4.6

10.5

00

6.3

00

Mantoo[46]

2013

44

191

40

00

50

0

(c)

Tsiaoussis[6]

2005

23(27)‡

NR

NR

22

NR

NA

NR

NR

0

VonPapen

[7]

2007

56

123

413

70

20

0

(d)

Author

Year

Operation

NDuration,mins

LOS

Totalcx,%

Re-op%

Meshcomps,%

Conv,

%Stoma,

%Mort,%

vanTets[4]

1995

Posteriormeshrectopexy

37

NR

NR

NR

NR

NR

NA

NR

NR

Vermeu

len[54]

2005

Anteriormeshrectopexy

20

NR

8.5

15

00

NR

00

Portier[49]

2011


23(40)*

NR

NR

7.5

00

NR

00

LOS,length

ofstay;Cx,

complications;Re-op,reoperation;Conv,

conversion;Mort,mortality;

NR,notreported

.

*17werelaparoscopic,23open

.

‡4open

.




complication rates (Fig. 2), with individual study rates

varying from 0.0% to 23.5% (Table 2). Such hetero-

geneity may reflect different inclusion, thresholds or

conventions for recording complications. Complica-

tions typically occurred in about 5–15% of patients.

Pooled findings suggest that LRR might be associated

with higher morbidity (total complications 15% for

LRR vs 10% LVMR) although the findings were not

statistically significant (Z-test, P = 0.30), and absolute

patient numbers were small for LRR. The majority of

complications were minor and included urinary tract

infections (the most common reported), wound infec-

tions, haematoma formation, persistent pain and uri-

nary retention. There were some more serious

complications including port-site hernia, small bowel

obstruction (usually after conversion but also related

to mesh or suture adhesions), osteomyelitis and blad-

der injury (often when associated to bladder prolapse

surgery). Specific mesh complication rates were rare,

with only five occurrences after 939 procedures

(0.53%). Overall, procedures were safe: conversion to

laparotomy was rare (median 2%, range 0–8%)(Table 2), with the most common reason being adhe-

sions; stoma was only reported in one study; no peri-

operative deaths were reported. Two open rectopexy

procedures (posterior mesh) were described, but data

concerning post-operative complications were limited.

There was no mortality recorded after any resuspension

procedures.


1 Data on harms were inconsistently reported and

heterogeneous, making estimates of harm tentative

and imprecise (level IV).

2 Complications typically occurred in about 5–15% of

procedures (level IV).

3 Mesh complications were reported in a minority of

studies and occurred in about 0.5% (range 0–3.9%)of patients overall (level IV).

4 No mortality was recorded after any resuspension

procedure, in a total of 1044 patients reporting this

outcome (level IV).

Efficacy

Measurement of clinical outcomes was inconsistent and

included the variable use of validated and un-validated

scoring instruments for symptoms, such as Patient

Assessment of Constipation Quality of Life (PAC-


total procedural complications

(percentage of patients) after rectopexy

by procedure type. KEY: LVMR,laparoscopic ventral mesh rectopexy;

RVMR, robotic ventral mesh rectopexy;

LRR, laparoscopic resection rectopexy;OR, open rectopexy.




QOL) and Patient Assessment of Constipation-Symp-

toms (PAC-SYM) scores (one study only) [57], Cleve-

land Clinic Constipation score [34,47,48,50,51,53,56],

obstructed defecation syndrome (ODS) score

[46,50,56,58], Knowles-Eccersley-Scott score (KESS)

[48], Cleveland Clinic Incontinence score [46,49,56],

Faecal Incontinence Severity Index (FISI) [47,48,51–53,56–58] and St Marks Incontinence score [48]. Glo-

bal ‘success’ or ‘satisfaction’ ratings (GSR) were

obtained via a variety of methods in 7 studies (where

‘satisfied’ or ‘very satisfied’, ‘good’, ‘very good’, and

‘excellent’ were interpreted as a positive outcome or

overall improvement). Further studies also reported

individual symptoms. No study reported acquiring data

objectively using personnel not involved in the surgical

care of the patient or data collection blinded to inter-

vention status. Average reported studies follow-up was

31 months (range 12–72 months).

Accepting these methodological limitations, several

reports assert that most patients undergoing rectal sus-

pension procedures were satisfied. Meta-analysis of stud-

ies reporting a summary measure found considerable

heterogeneity, which may reflect variation in measure-

ments, patients or procedures. Overall improvement (a

good or satisfactory outcome) was reported in 83%

(95%CI: 74–91%, I2 = 77%) of cases, based on 328

patients (Table 3; Fig. 3). Similar levels of improvement

were recorded for LVMR and OR; only one small study

reported improvement after LRR, and data were not

available for RVMR.

The initial aim of ‘suspension’ procedures is to

treat symptoms. Functional assessment of constipation

is therefore the most important outcome. However,

many patients also suffer from incontinence, typically

post-defaecatory seepage. The various scoring instru-

ments and functional outcomes employed are reported

in Table 4. Generally, measures are too sparsely

reported to be informative. For LVMR, Cleveland

Clinic Constipation score improved from a median of

14 (range 7–18) to a median of 5 (range 4–7) in 6

studies providing pre- and post-operative data.

Improvement in constipation was highly heteroge-

neous and only reported in a minority of studies,

varying from 20% to 97%. By pooling data for LVMR,

the reported improvement in constipation was 86%

(95%CI: 20–97%).While the clinical outcome has primacy, the most

immediate visible consequence of surgery is to correct

anatomy. Therefore, an assessment of anatomical recur-

rence is also important (although necessarily represent-

ing only a surrogate outcome). Anatomical recurrence

rates varied between 0 to 21% (Fig. 4), but typically

occurred in 2–7% of patients in most studies. Functional

outcome data on robotic surgery and LRR were rarely

available, but again anatomical correction was very likely

achieved with both procedures. No conclusions about

functional or anatomical outcomes could be made for

the other rectopexy procedures.

Table 3 Overall improvement based on global satisfaction rat-

ings (GSR). (a) Laparoscopic ventral mesh rectopexy (LVMR).

(b) Robotic ventral mesh rectopexy (RVMR). (c) Laparoscopic

resection rectopexy (LRR). d) Open rectopexy (OR).

(a)

Author Year

Follow

up

(months) N

%

success

Collinson [48] 2009 12 75 NR

Kargar [55] 2011 22 39 74

Portier [49] 2011 32 40 (17*) 97

Wong [45] 2011 12 25 NR

Wong [50] 2011 29 84 NR

Sileri [51] 2012 12 34 NR

Wahed [52] 2012 12 65 71

Formijne

Jonkers [56]

2013 30 233 NR

Gosselink [57] 2013 12 151 NR

Mantoo [46] 2013 16 74 NR

Borie [58] 2014 NA 25 NR

Evans [34] 2015 36 30 NR

Franceschilli [53] 2015 20 100 89

Tsunoda [47] 2015 16 26 NR

(b)

Wong [45] 2011 12 16 NR

Mantoo [46] 2013 16 44 NR

(c)

Tsiaoussis [6] 2005 45 23 (27)‡ 93

Von Papen [7] 2007 44 56 NR

(d)

Author Year Operation

Follow

up

(months) N

%

success

van Tets [4] 1995 Posterior

mesh

rectopexy

72 37 70

Vermeulen

[54]

2005 Anterior

mesh

rectopexy

18 20 63

Portier [49] 2011 Anterior

mesh

rectopexy

22 40 (23*) 97

Cx, complications; NR, not reported.

*17 were laparoscopic, 23 open.

‡4 open.





1 Data on efficacy were inconsistently reported and

findings heterogeneous, making estimates tentative


2 Although inconsistent, patient GSR suggest that a

good or satisfactory outcome typically occurs in 83%

(74–91%) of patients (level IV).3 Similar levels of satisfaction were recorded for all pro-

cedures where data were available (LVMR, OR,

LRR) (Level IV).

4 Patient-reported improvements in constipation

occurred in 86% (95%CI: 20–97%) of patients after

LVMR (Level IV).

5 Limited evidence found consistently improved Cleve-

land Clinic Constipation scores for patients undergo-

ing LVMR (level IV).

6 Anatomical recurrence typically occurred in about 2–7% of patients (level IV).

Patient selection

Patient selection is perceived by many experts as extre-

mely important when choosing the surgical approach.

Whilst these procedures may be efficient at correcting

normal anatomy (median 95%, range 79–100%), many

underlying functional and organic pathologies may

jeopardize the success of surgery in the attempt of ‘cur-

ing’ the patient [61]. Fifteen of 18 papers highlight the

fact that all patients had undergone a period of conser-

vative management. Other than this common feature,

selection was inconsistent. Even the diagnosis of abnor-

mal anatomy varied throughout the literature. Studies

described interventions for patients with: ungraded

intussusception [7,54]; ‘rectoanal’ intussusception

[6,47]; ‘high grade’ intussusception [57]; ‘grade 3 or 40

intussusception [48,49,51,53,56]; ‘anterior or circum-

ferential’ intussusception [4]; rectocoele +/- intussus-

ception [52,54,58] or +/- cystocoele [13]; complex

rectocoele of above 2–3 cm [50]; multi-compartment

pelvic floor disorders [46]; solitary rectal ulcer syn-

drome (SRUS) [34,55]. Thus, it was difficult to draw

any conclusions as to which group could benefit from

intervention. When summarising the data, the most

common theme regarding patient selection is a high

grade intussusception (i.e. rectoanal or Oxford grade

≥ 3). Table 5 lists the papers where this inclusion crite-

rion has been adopted and one of the primary indica-

tions along with a summary of the outcome measures

reported (if given in more than one paper). The conclu-

sions from this sub-analysis resemble those described in

the whole review.

SRUS deserves specific mention as two papers

included patients specifically diagnosed with this condi-

tion [34,55]. Patients report passage of mucus and

bloody liquid on defaecation, with an ulcer seen within

the rectum. Treatment is conservative, initially using

biofeedback and behavioral intervention. A proportion

of patients present an element of internal intussuscep-

tion, which may reflect the ulcerated area as the apex of

the intussusception, repetitively traumatised with strain-

ing. The surgical correction of a prolapse (when


overall improvement (percentage of

patients) after rectopexy by proceduretype. KEY: LVMR, laparoscopic ventral

mesh rectopexy; LRR, laparoscopic

resection rectopexy; OR, open rectopexy.




Table

4Functional

andclinical

outcomes

byprocedure.(a)Laparoscopic

ventral

meshrectopexy(L

VMR).(b)Roboticventral

meshrectopexy(R

VMR).(c)Laparoscopic

resection

rectopexy(L

RR).(d)Open

rectopexy(O

R).

(a)

Author

Year

NCCSpre

CCSpost

ODS

pre

ODS

post

FISIpre

FISIpost

Constipation

improved%

Anatomical

recurren

ce%

Collinson[48]

2009

75

12

5NR

NR

28

886

5

Kargar

[55]

2011

39

NR

NR

NR

NR

NR

NR

NR

NR

Portier[49]

2011

40

NR

NR

NR

NR

NR

NR

Worse

2.5

Wong[45]

2011

25

NR

NR

NR

NR

NR

NR

NR

0

Wong[50]

2011

84

75

NR*

NR*

NR

NR

Improved

6.3

Sileri[51]

2012

34

16

7NR

NR

93

NR

5.9

Wahed

[52]

2012

65

NR*

NR*

NR

NR

NR*

NR*

97

3.7

Form

ijne

Jonkers

[56]

2013

233

NR

8.1

NR*

NR*

NR*

NR*

81

2.6

Gosselink[57]

2013

151

NR

NR

NR

NR

NR*

NR*

NR

NR

Mantoo[46]

2013

74

NR

NR

NR†

NR†

NR

NR

NR

8

Borie[58]

2014

25

NR

NR

16

7.6

24

220

NR

Evans[34]

2015

30

17

6NR

NR

19

NR

NR

21

Franceschilli[53]

2015

100

18.4

5.5

NR

NR

NR*

NR*

89

14

Tsunoda[47]

2015

26

11

4NR

NR

30

6NR

3.8

(b)

Wong[45]

2011

16

NR

NR

NR

NR

NR

NR

NR

NR

Mantoo[46]

2013

44

NR

NR

NR

NR

NR

NR

NR†

8

(c)

Tsiaoussis[6]

2005

23(27)‡

NR

NR

NR

NR

NR

NR

NR

0

VonPapen

[7]

2007

56

NR

NR

NR

NR

NR

NR

53

3.6

(d)

Author

Year

Operation

NCCSpre

CCS

post

ODS

pre

ODSpost

FISI

pre

FISI

post

Constipation

improved%

Anatomical

recurren

ce%

vanTets[4]

1995

Posteriormeshrectopexy

37

NR

NR

NR

NR

NR

NR

NR

NR

Vermeu

len[54]

2005


20

NR

NR

NR

NR

NR

NR

NR

NR

Portier[49]

2011


40(23�)

NR

NR

NR

NR

NR

NR

Worse

2.5

NR,notreported

;CCS,ClevelandClinic

Constipationscore.

*significantim

provemen

t(nodatagiven

).

†decreased

orim

provedbutnotsignificantly(nodatagiven

).

‡4open

;�23open

procedures.




detected) may be reasonable in the hope of resolving

the ulcer. Data on a total of 75 patients with SRUS

who have undergone LVMR are available from the two

papers. Healing of the ulcer occurred in 78% of patients

after surgery.


1 Although patient selection is perceived as vital in pre-

dicting outcome, it was inconsistently documented

(level IV).


anatomical recurrence (percentage of

patients) after rectopexy by proceduretype. KEY: LVMR, laparoscopic ventral

mesh rectopexy; RVMR, robotic ventral

mesh rectopexy; LRR, laparoscopic

resection rectopexy; OR, open rectopexy.

Table 5 Summary of papers where participants had a high grade internal intussusception (rectoanal, Oxford grade ≥ 3).

Author Year Op N FU % success

CCS

pre

CCS

post

FISI

pre

FISI

post

Constipation

improved

Anatomical

recurrence

Tsiaoussis [6] 2005 † 27 45 93 NR NR NR NR NR 0

Collinson [48] 2009 LVMR 75 12 NR 12 5 28 8 86 5

Portier [49] 2011 * 40 22 97 NR NR NR NR Worse 2.5

Wong [45] 2011 ‡ 41 12 NR NR NR NR NR NR 6.3

Sileri [51] 2012 LVMR 34 12 NR 16 7 9 3 NR 5.9

Formijne

Jonkers [56]

2013 LVMR 233 30 NR 8.1 NR NR NR NR 2.6

Gosselink [57] 2013 LVMR 151 12 NR NR NR NR NR NR NR

Borie [58] 2014 LVMR 52 1–18 NR NR NR 24 2 20 NR

Evans [34] 2015 LVMR 30 36 NR 17 6 19 NR NR 21

Franceschilli [53] 2015 LVMR 100 20 89 18.4 5.5 NR NR 89 14

Tsunoda [47] 2015 LVMR 26 16 NR 11 4 30 6 NR 3.8

*Lap and Open Ant mesh rectopexy.

†Lap resection rectopexy.

‡LVMR and RVMR.




2 One common indication appears to be high grade

rectal intussusception (level IV).

3 For high grade intussusception, LVMR, RVMR and

resection rectopexy typically correct anatomy in

about 80–100% of cases (level IV).

4 If SRUS is associated with prolapse, a LVMR typi-

cally results in healing of the ulcer in around 80% of

patients (level IV).

Discussion


and long terms benefits and harms of rectal suspension

procedures identified no high quality studies. The evi-

dence base is characterised by observational studies of

variable and often uncertain methodological quality.

Definitions are poor, e.g. grading of complications was

inconsistent. Future studies should provide robust and

comparative evidence for clinicians to support patient

decision making, in terms both of the incremental bene-

fits and harms of suspension procedures. A Clavien-

Dindo (or equivalent) classification is essential. Greater

understanding is required of the mediating effects of

prognostic factors particularly preoperative definition of

both functional and radiological parameters that impact

upon treatment success. Relevant to future research

would be to define a minimum set of outcomes for

reporting future studies. Finally, and most obviously,

the evidence base requires urgent augmentation with

some high quality studies focused on having at least

one well powered randomized controlled trial to inform

future clinical decision making.

Acknowledgments


































Foundation Trust.


The authors declare no conflict of interest.

Funding



Research (RP-PG-0612-20001). The views and opin-

ions expressed in this report are those of the authors

and are not those of the PGfAR Programme, NIHR,

the UK National Health Service, or the UK Depart-

ment of Health.

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Results III: Rectal wall excisional procedures (Rectal Excision)

M. Mercer-Jones*, U. Grossi†, D. Pares‡, P. F. Vollebregt†, J. Mason§, C. H. Knowles†, on behalf

of the NIHR CapaCiTY working group¶ and the Pelvic floor Society**

*Queen Elizabeth Hospital, Gateshead NHS Trust, Gateshead, UK, †National Bowel Research Centre, Blizard Institute, Queen Mary, University London,

London, UK, ‡Hospital Germans Tr�ıas i Pujol, Barcelona, Spain, §University of Warwick, Coventry, UK, ¶National Institute for Health Research: Chronic

Constipation Treatment Pathway, London, UK and **Affiliate section of the Association of Coloproctology of Great Britain and Ireland

Abstract

Aim To assess the outcomes of rectal excisional proce-

dures in adults with chronic constipation.







Results Forty-seven studies were identified, providing

data on outcomes in 8340 patients. Average length of

procedures was 44 min and length of stay (LOS) was

3 days. There was inadequate evidence to determine vari-

ations in procedural duration or LOS by type of proce-

dure. Overall morbidity rate was 16.9% (0–61%), with

lower rates observed after Contour Transtar procedure

(8.9%). No mortality was reported after any procedures in

a total of 5896 patients. Although inconsistently

reported, good or satisfactory outcome occurred in 73–80% of patients; a reduction of 53–91% in Longo scoring

system for obstructive defecation syndrome (ODS)

occurred in about 68–76% of patients. The most common

long-term adverse outcome is faecal urgency, typically

occurring in up to 10% of patients. Recurrent prolapse

occurred in 4.3% of patients. Patients with at least 3 ODS

symptoms together with a rectocoele with or without an

intussusception, who have failed conservative manage-

ment, may benefit from a rectal excisional procedure.

Conclusion Rectal excisional procedures are safe with

little major morbidity. It is not possible to advise which

excisional technique is superior from the point of view

of efficacy, peri-operative variables, or harms. Future

study is required.

Keywords surgery, constipation, rectal excision,

STARR, TRANSTAR

Introduction


Chronic constipation is related to an inability to evacu-

ate the rectum in over half of all adults presenting for

specialist advice. This phenomenon, which may be vari-

ably described as obstructed defaecation or rectal evacu-

ation disorder (and many other terms) is characterized

by excessive straining, the feeling of incomplete evacua-

tion, post-defaecatory seepage and often mucous dis-

charge and pelvic pain [1]. In some of these patients,

there is clinical and radiological (usually proctographic)

evidence of a dynamic structural abnormality, leading

to physical impediment to emptying during defaecation.

The most common abnormalities are rectocoele and/or

intussusception. Theoretically, these anatomical variants

could lead to the features of obstructed defaecation by

a process of loss of force vector (ballooning of the rec-

tum into a rectocoele or invagination of the rectum

into an intussusception, rather than evacuation of stool

on straining) or mucosal obstruction (in the case of an

intussusception) [1]. Correction of these variants can

be carried out by surgically excising the redundant rec-

tal wall, i.e. that ballooning out or prolapsing in, thus

restoring ‘normal’ anatomy.

Techniques

The stapled transanal rectal resection (STARR) proce-

dure uses two circular procedure for prolapsing

Correspondence to: Mr Mark Mercer-Jones, Queen Elizabeth Hospital, NE9

6SX Gateshead NHS Trust, Gateshead, UK.

E-mail: [email protected].







haemorrhoids (PPH)01 stapling devices (Ethicon Endo-

surgery, INC., Cincinnati, Ohio, USA), or at times,

two circular PPH03 devices. They are used sequentially

to remove the anterior rectal wall prolapse and then the

posterior rectal wall prolapse. These full thickness rectal

wall excisions result in defects that are anastomosed

with staples contained within the device. The STARR

procedure was derived from the technique of stapled

haemorrhoidopexy and was introduced into clinical

practice by Antonio Longo using the PPH01 device

[2]. Initially, most STARR procedures were performed

with PPH01; however, subsequently the PPH03 device

was developed, essentially for haemorrhoidopexies, to

reduce intra-operative staple line bleeding. The two

devices, PPH01 and PPH03, differ only with respect to

the closed staple height, which varies between 1–2.5 mm and 0.75–1.5 mm, respectively. The PPH03

device is no longer licensed for use for STARR because

of concerns that the staple line height was insufficient

for the thickness of tissue that was resected and anasto-

mosed. As with all new techniques, in order to ensure

that safety and efficacy concerns were addressed, a num-

ber of initiatives were put in place by the manufacturer.

The procedure could only be performed by trained sur-

geons who then mentored other surgeons. In the UK,

the PPH01 device is no longer used for haemor-

rhoidopexies, and consequently Ethicon will only per-

mit the sale of this device to institutions with surgeons

trained in the STARR technique. The European

STARR registry was established through collaboration

between Ethicon Endosurgery and the colorectal soci-

eties in the UK, France, Germany and Italy. Outcomes

from this registry have been published and, in response,

the National Institute for Health and Care Excellence

(NICE) issued interventional procedure guidance in

2010. The NICE guidance concluded that ‘the current

evidence on safety and efficacy of stapled transanal rec-

tal resection (STARR) for obstructed defaecation syn-

drome (ODS) is adequate . . . . . . the procedure may

therefore be used with normal arrangements for clinical

governance, consent and audit.’ [www.nice.org.uk/

ipg351].

Despite its proven safety and efficacy, the STARR

procedure still had limitations. These were primarily

related to the stapling device itself. The two biggest

concerns were that the rectal resection was performed

‘blind’ within the low rectum and that the volume of

the resected tissue was entirely dependent upon the

capacity of the stapling device housing, rather than the

extent of the prolapse. As such, the surgeon was

unable to modify the extent of resection in relation to

the size of the prolapse. Consequently, a new stapling

device, the Contour Transtar curved cutter stapler

(Ethicon Endosurgery, INC.), was introduced [3] in

order to allow a tailored correction of the prolapse by

removing more tissue. It would also allow this resec-

tion to be performed under direct vision. The Contour

Transtar stapler utilises replaceable staple cartridges

allowing multiple firings with a single device.

Although STARR has been heavily popularized, it is

not the first procedure to use of rectal excision as a

means of treating prolapse. Edward Delorme originally

described his procedure for full-thickness external rectal

prolapse in 1900 [4]. There have been several modifica-

tions, one being an intra-anal Delorme’s procedure for

the treatment of recto-anal intussusception [5]. Unlike

STARR and Contour Transtar, there is no full-thickness

rectal wall excision and only the redundant mucosa is

excised. The mucosa is stripped cephalad, and the

underlying muscle is plicated together with sutures to

concertina the prolapse.

Scope

The purpose of this review was to assess the efficacy

and harms of rectal excisional procedures for internal

prolapse and/or rectocoele in adults. Procedures con-

sidered beyond the scope of systematic review included:

(i) those where ‘tightening’ is effected without excision

(covered in rectovaginal reinforcement systematic

review); (ii) those where only mucosa is excised (muco-

sectomy) and there is no plication of the muscular wall;

(iii) those where a mucosectomy and plication are lim-

ited to the anterior wall (covered in rectovaginal rein-

forcement systematic review); (iv) those where the

whole rectum is resected rather than a component of

the wall, i.e. as occasionally performed for megarectum

[6]. Studies where outcomes could not be segregated

by eligible procedure were also excluded, due to a

mixed patient population with internal and external rec-

tal prolapse, mixed indications, including numerous pel-

vic floor abnormalities or limited postoperative

outcomes, transanal endocopic microsurgery proce-

dures, technical reports, or cost analyses only.

Previous reviews

One previous meta-analysis including 26 studies [7]

addressed the outcome of rectal excisional procedures

for constipation.

Summary of search results and studyquality

The search yielded a total of 84 articles for full text

review (Fig. 1). From these, 47 published between



Rectal excision for constipation M. Mercer-Jones et al.

http://www.nice.org.uk/ipg351

http://www.nice.org.uk/ipg351

2000 and 2014 contributed to the systematic review,

providing data on outcomes in a total of 8340 patients

(range 20–2224 patients per study) (Table 1). Specific

exclusions after full-text review (and after exclusion of

non-English language publications) included nine stud-

ies where the population sample was confirmed to be

< 20 patients, eight where follow-up was < 12 months;

five studies with out of scope procedures [8–11], threestudies where data were considered duplicate [12,13],

and three where outcomes could not be segregated by

eligible procedure. Other exclusion criteria were: indica-

tion not constipation (n = 1) and lack of extractable

outcome data (n = 5).

The quality of studies varied. The 47 included stud-

ies (Table 1) included 42 observational studies and five

randomised controlled trials (RCTs). The latter

included three good quality RCTs (level IB) with low

levels of predicted bias, and two with less well described

methodology (level IIB). The remaining 42 observa-

tional studies encompassed several good quality

prospective cohort studies with low levels of bias includ-

ing four prospectively maintained funded registries

(level IIB). Other studies were a mix of prospective and

retrospective case series. Mean study follow-up was

1.9 years (range 1.0–5.5 years); 36 studies originated

from European centres, three from the USA and eight

from other countries.

Perioperative data

Perioperative data were reported by 47 studies reporting

55 procedures (Tables 2 and 3). Measures of variation

of continuous measures included ranges or standard

deviations but were inconsistently reported. Average

procedural duration and length of stay (LOS) varied

between procedures but design heterogeneity, small

numbers of studies and large range of values precluded

any clear conclusions (Table 3). The overall average

duration of procedures reported by cohorts was 44

(range 23–95) min, and the overall average LOS was

3.0 (range 1.0–8.0) days (Figs 2 and 3). In one RCT

of 100 patients (STARR vs Contour Transtar) [37],

Contour Transtar took significantly longer to perform

(52.2 vs 42.4 minutes P = 0.008). However this reduc-

tion was not apparent more broadly within the pooled

findings (Fig. 2). While LOS for intra-anal Delorme’s

procedure was shorter (2 days) this was based on only

one study reporting this outcome in 34 patients.




M. Mercer-Jones et al. Rectal excision for constipation



Liberman [14] 2000 Omaha USA 34 43 RCS IV

Boccasanta [15] 2004 Milan Italy 50 23 RCT IB

Boccasanta [16] 2004 Milan Italy 90 16 PCH IIB

Pescatori [17] 2006 Rome Italy 26 36 RCS IV

Arroyo [18] 2007 Elche Spain 37 24 PCH IIB

Gagliardi [19] 2008 Multicentre Italy 85‡ 17 RCS IV

Dindo [20] 2008 Zurich Switzerland 24 18 PCH IIB

Lehur [21] 2008 Multicentre France, Italy, UK 119 12 RCT IIB

Arroyo [22] 2008 Multicentre Spain 104 26 PCH IIB

Lenisa [3] 2009 Multicentre Europe 75 12 PCH IIB

Harris [23] 2009 Orlando USA 75 12 RCH IV

Jayne [24] 2009 Multicentre UK, Germany, Italy 2224§ 12 PCH IIB

Reboa [25] 2009 Genoa Italy 33 18 PCH IIB

Boccasanta [26] 2010 Milan Italy 142 24 PCH IIB

Isbert [27] 2010 Nuremberg Germany 150 12 RCH IIB

Zhang [28] 2010 Beijing China 50 12 PCH IIB

Madbouly [29] 2010 Alexandria Egypt 46 42 PCH IIB

Schwandner [30] 2010 Regensburg Germany 379 12 PCH IIB

Ram [31] 2010 Ramat Aviv Israel 30 26 PCS IV

Zehler [32] 2010 Hamburg Germany 20 66 PCS IV

Goede [33] 2011 Bristol UK 344 12 PCS IV

Meurette [34] 2011 Nantes France 30 48 PCS IV

Martellucci [35] 2011 Siena Italy 133 19 PCS IV

Patel [36] 2011 Houston Texas 37 20 PCH IIB

Boccasanta [37] 2011 Milan Italy 100 36 RCT IB

Stuto [38] 2011 Pordenone Italy 2171 12 PCH IIB

Song [39] 2011 Seoul South Korea 58 34 RCH IV

Ding [40] 2011 Beijing China 86 12 PCH IIB

Renzi [41] 2011 Naples Italy 61 24 RCT IB

Reibetanz [42] 2011 Wuerzburg Germany 170 18 RCH IIB

Naldini [43] 2011 Pisa Italy 30 24 PCH IIB

Biviano [8] 2011 Rome Italy 60 38 PCH IIB

Savastano [44] 2012 Vicenza Italy 64 27 PCH IIB

Jiang [45] 2012 Wuhan China 43 12 RCS IV

Boenicke [46] 2012 Wuerzburg Germany 181 19 PCH IIB

Kohler [47] 2012 Dresden Germany 80 39 PCS IV

Hasan [48] 2012 Cairo Egypt 40 12 PCH IIB

Ganio [49] 2013 Vercelli Italy 167 36 RCS IV

Adams [50] 2013 London UK 37 13 RCS IV

Masoni [51] 2013 Rome Italy 187 12 RCS IV

Bock [52] 2013 St Gallen Switzerland 70 48 RCS IV

Zhang [53] 2013 Beijing China 75 30 PCH IIB

Panicucci [54] 2014 Pisa Italy 54 12 PCH IIB

Borie [55] 2014 Nimes France 52 18 RCH IV

Ribaric [56] 2014 Multicenter Europe 100 12 PCH IIB

Gentile [57] 2014 Naples Italy 66 12 RCT IIB

Leardi [58] 2014 L’Aquila Italy 51 36 PCS IV

RCS, retrospective cohort study; PCS, prospective case series; RCT, randomised controlled trial; PCH, prospective cohort study.


†Oxford CEBM [13].

‡Report on 123 patients, but only 85 operated on.

§Report on 2838 patients for complications, 2224 reached 12 months follow-up.




Table 2 Perioperative data by procedure.

Author Year N

Time

(minutes) LOS (days)

Post-op

bleed

Req.

Treatment %

Sepsis

%

Post-op

anastomotic

dehiscence

%

Total

complications

%

Mortality

%

(a) PPH-01

Boccasanta [15] 2004 25 41.8 � 6 2.1 � 0.8 4 0 0 40 0

Boccasanta [16] 2004 90 43.3 � 9 2.1 � 0.8 4.4 0 0 16.5 0

Arroyo [18] 2007 17 45.9 (9.8) NR 6 0 0 NR 0

Gagliardi [19] 2008 85 † NR NR 2.3 3 0 18 0

Dindo [20] 2008 24 60 (40–110) 3 (1–10) 4.1 0 0 25 0

Lehur [21] 2008 119 40 (15–56) 2.1 (1–6) 1.8 1.8 0 15 0

Arroyo [22] 2008 37‡‡ 46.7 (9.3) 2.2 (0.7) 2.8 0 0 NR 0

Boccasanta [26] 2010 74 35.8 � 6.1 2.6 � 0.5 4 0 0 28.3 0

Harris [23] 2009 36 52.7 2.6 19.4§§ 2.8 0 61.1¶¶ 0

Isbert [27] 2010 68 57 � 15.4 3.4 � 1.6 3 0 2 7.3 0

Jayne [24] 2009 2224‡ 44 (15–210) 3.7 (1–36) 5 4.4 3.5* 36 0

Reboa [25] 2009 33 37 � 7 1.5 � 0.6 0 0 0 15.1 0

Zhang [28] 2010 50 28 NR 0 0 0 NR 0

Madbouly [29] 2010 46 48.4 � 9.6 1 0 0 0 15.2 0

Schwandner [30] 2010 379 40 5.5 2.9 1.6 7.1* 21.2 0

Ram [31] 2010 30 40 (35–80) 2 (1–4) 0 0 NR 36.7 0

Zehler [32] 2010 20 53.5 (45–65) 8 (3–22) 15 0 0 20 0

Goede [33] 2011 344 NR NR 2.7 NR NR 16.3 0

Meurette [34] 2011 30 40 � 8 3 � 1 NR NR NR 27 0

Patel [36] 2011 37 NR 1 0 NR NR 35.1 0

Boccasanta [37] 2011 50 42.4 (6.9) 3.2 (0.6) 2 0 0 4 0

Stuto [38] 2011 2171¶ 95 (15–230) 3.6 (1–21) NR NR NR NR NR

Song [39] 2011 58 35.1 � 11.3 3.91 � 0.84 4 0 NR NR 0

Ding [40] 2011 86 30 � 7 5 � 1.8 0 0 0 NR 0

Renzi [41] 2011 30 28.1 (11.5) 1.2 (0.5) 6.6 0 NR NR 0

Reibetanz [42] 2011 170§ NR NR 0 0 0.6 7 0

Naldini [43] 2011 15 NR 3.4 (3–6) 0 NR NR 0 0

Biviano [8] 2011 30 NR NR 0 0 0 6 0

Savastano [44] 2012 32 28 (20–45) 2 (1–3) 13 0 0 NR 0

Boenicke [46] 2012 181** NR NR 1 0 0.5 8.2 0

Kohler [47] 2012 80 67 (34–182) NR 6 1 1 22.5 0

Hasan [48] 2012 40 35 � 10 1.7 � 2.3 0 0 0 NR 0

Adams [50] 2013 37 NR 1 (0–8) 5.4 2.7 0 32 0

Zhang [53] 2013 75 NR NR 0 0 0 NR 0

Panicucci [54] 2014 54 †† NR NR NR NR NR NR NR

Borie [55] 2014 25 NR 5.6 � 2.1 0 0 0 24 0

Leardi [58] 2014 51 NR 3 2 0 0 2 0

(b) PPH03

Arroyo [18] 2007 20 40.1 (10.4) NR 0 0 0 NR 0

Arroyo [22] 2008 67*** 46.7 (9.3) 2.2 (0.7) 2.8 0 0 NR 0

Jiang [45] 2012 43 23 � 4 5 (4–6) 0 0 0 NR 0

Gentile [57] 2014 30 40 NR NR NR NR 20 NR

(c) Contour Transtar

Lenisa [3] 2009 75 45 (24–90) 4 (1–16) 2.6 0 0 7 0

Isbert [27] 2010 82 51 � 18.2 3.6 � 2.3 3 0 0 7.5 0

Martellucci [35] 2011 133 42 (26–71) NR 1.5 NR 1.5 15.7 0

Boccasanta [37] 2011 50 52.2 (8.7) 3.5 (1.0) 2 0 0 2 0

Renzi [41] 2011 31 33.1 (15.7) 1.25 (0.5) 3.2 0 NR NR 0





1 The average duration of procedures was 44 min,

although this ranged widely between studies from 23

to 95 min (level II).

2 The average length of stay was 3 days although this

ranged widely between studies from 1 to 8 days

(level II).

3 There was inadequate evidence to determine varia-

tions in procedural duration or length of stay by type

of procedure (level IV).

Harms

Perioperative complications

Five measures of perioperative harm were reported by a

majority of studies within the review. In general, there was

considerable heterogeneity between cohort findings. This

heterogeneity may have reflected (for example) differing

inclusion, procedural content, context of care, or thresh-

olds or conventions for recording complications.

Overall procedural complication rates varied between

cohorts from 0% to 61% Fig. 4. Random effects meta-

analysis found the overall complication rate to be 16.9%

(95% CI: 12.7–21.5%), I2 = 93%. The Contour Transtar

procedure reported a lower overall complication rate of

8.9% (95% CI: 5.1–13.5%), I2 = 70%, although cohort

findings within this category were heterogeneous and

non-comparative. The two RCTs (IB) comparing STARR

to Contour Transtar reported no difference in periopera-

tive complication rates [37,41], although these included

only 161 patients in total and six events. A more general-

isable estimate of the overall complication rate may come

from the European STARR registry which reported an

overall morbidity rate of 36% from 2838 patients [24].

The inclusion criteria for morbidity in this registry incor-

porated urgency (20%), but this was not universally

applied in most other studies, explaining its discrepancy

from the pooled findings.

Rates of post-operative bleeding requiring treatment

varied between cohorts from 0% to 19% (Fig. 5). Ran-

dom effects meta-analysis found the pooled bleed rate

to be 1.6% (95% CI: 0.9–2.5%), I2 = 63%. Regarding

Table 2 (Continued).

Author Year N

Time

(minutes) LOS (days)

Post-op

bleed

Req.

Treatment %

Sepsis

%

Post-op

anastomotic

dehiscence

%

Total

complications

%

Mortality

%

Naldini [43] 2011 15 NR 3.1 (2–5) 3.3 NR NR 3.3 0

Savastano [44] 2012 32 43 (32–65) 4 (3–7) 6 0 9.3 NR 0

Masoni [51] 2013 187 48 (32–78) < 3 0 0 0 7.4 0

Bock [52] 2013 70 NR NR 0 0 0 23 0

Ribaric [56] 2014 100 43.8 � 13.9 4.36 � 2.75 1 0 0 11 0

(d) Intra-anal Delorme’s procedure

Liberman [14] 2000 34 NR 1.8 (2.4) 3 8.8 0 35.3 0

Pescatori [17] 2006 26 NR NR 15.4 16††† 12.5††† 45††† 0

Ganio [49] 2013 167‡‡‡ NR NR 0 1.2 1.8 10.2 0

Gentile [57] 2014 36 65 NR NR NR NR 19.4 0

NR, not recorded.

All PPH03, except Jiang [45] translinear stapler.

*Reported as staple line complications, including dehiscence.

†Report on 123 patients, but only 85 operated on.

‡Report on 2838 patients for complications, 2224 reached 12 months follow-up.

§101 patients had Countour Transtar.

¶208 patients had Contour Transtar.

**Some patients had Contour Transtar.

††18 patients had Contour Transtar.

‡‡Complications are reported for 104 patients (67 had PPH03).

§§It is uncertain if this required intervention as recorded as ‘rectal bleeding’.

¶¶Total complications included tenesmus, diarrhoea, faecal incontinence, and pruritis ani.

***Complications are reported for 104 patients (37 had PPH01); NR: not recorded.

†††These percentages are based upon analysis of 40 patients (14 patients having had PPH01 or PPH01 with manual mucosectomy).

‡‡‡91 patients also had levatoroplasty.




intra-operative bleeding from staple lines, results from

one prospective cohort study (IIB) showed that less

intraoperative staple line sutures were required with

PPH03 compared with PPH01 [18]. Details of treat-

ments provided (e.g. transfusion or re-operation) were

unclear in many instances.

Sepsis rates varied from 0% to 16%, but were consis-

tently low, occurring in no patients in 78% of cohorts

reported. Random effects meta-analysis found the sepsis

rate to be 0.2% (95% CI: 0.0–0.7%), I2 = 63%. Septic

complications were mostly related to urinary tract

infections, C. difficile infection, or more rarely, pneu-

monia. Sepsis rates for Delorme’s procedure appeared

high at 6.2% (95% CI: 0.0–19.4%), I2 = 82%, but find-

ings from the three studies were highly heterogeneous

and the only moderately large study [49] reported a

1.2% sepsis rate. The rate of post-operative anastomotic

dehiscence (wound rupture) varied between cohorts

from 0% to 13% but was consistently low, occurring in

no patients in 76% of cohorts reported. Random effects

meta-analysis found the pooled rate of anastomotic

dehiscence to be 0.3% (95% CI: 0.0–0.8%), I2 = 62%.

Table 3 Procedural data.

Procedure

Procedure duration (mins) Length of stay (days) Follow-up (months)

N Mean Range N Mean Range N Mean Range

PPH-01 25 44.6 (28.0–95.0) 25 2.9 (1.0–8.0) 37 23.0 (12.0–66.0)

PPH-03 4 37.5 (23.0–46.7) 2 3.6 (2.2–5.0) 4 18.5 (12.0–26.0)

Contour Transtar 8 44.8 (33.1–52.2) 7 3.4 (1.3–4.4) 10 22.6 (12.0–48.0)

Delorme’s 1 65.0 – 1 1.8 – 3 38.3 (36.0–43.0)

Total 37 43.8 (23.0–95.0) 35 3.0 (1.0–8.0) 54 23.5 (12.0–66.0)

Figure 2 Forest plot showing procedureduration by operation type.




There was inadequate evidence to select between proce-

dures on the basis of individual complications.

No deaths were reported in any cohort of patients

reporting mortality, which included a total of 5896

patients (Table 3). Incidences of serious complications

were reported but these were rare. These included: one

case of sepsis with retropneumoperitoneum [19], two

cases of intra-operatively recognized rectal perforation

requiring diverting colostomy [32,35], one case of rec-

tovaginal abscess requiring diversion [50], one case of

suture line disruption requiring diversion [30], and one

case of rectal necrosis requiring a colostomy [24]. There

were no cases of inadvertent small bowel injury as a

result of peritoneal inclusion with anterior rectal wall

excision and enterocoele excision. This is despite the

fact that in one study [42], 84 of 101 patients who had

Contour Transtar, and 14 of 69 patients who had

PPH01, had peritoneum present in the resected tissue.

Long-term adverse outcomes

Although obstructed defecation is a benign condition,

it may have a significant impact on a patient’s quality

of life. Studies have consistently reported a number of

long-term conditions and symptoms occurring after

stapled rectal excision procedures that may have a fur-

ther negative impact upon quality of life. Measures

reported by more than half of cohorts include: rectal

stenosis (83% of cohorts), recto-vaginal fistula (76%),

pain/proctalgia (70%), and urgency after defaecation

(72%); those less consistently reported include recur-

rent prolapse (46%) and dyspareunia (33%) (Table 4).

Random effects meta-analysis found that reported

rectal stenosis rates were 0.2% (95% CI: 0.0–0.6%),I2 = 30%, although individual cohorts varied from 0.0%

to 7.4%, with no stenosis reported in 67% of cohorts.

Recto-vaginal fistula was a very rare outcome, occurring

in just 3 of 4851 patients (0.062%) studied. Rectal pain

or proctalgia lasting > 6 months post-procedure was

reported by 0.7% of patients (95% CI: 0.1–1.6%),I2 = 79%, although individual cohorts varied from 0%

to 17%, with no proctalgia reported in 53% of cohorts.

Similarly to pooled findings, there was no difference in

pain comparing STARR and Contour Transtar in the

two level 1B RCTs [37,41]; at 36 months, the inci-

dence of pain was significantly less compared with pre-

Figure 3 Forest plot showing length of

stay by operation type.




operative values in both groups [37]. The two studies

with the highest reported incidence of proctalgia were

both PCHs (IIB). At 38 � 18 months post-STARR

(n = 30), 17% complained of intermittent anal pain,

however despite the fact that pre-operative Cleveland

Clinic Constipation scores were recorded, there was no

analysis about de novo pain [8]. At 12 months post-

STARR (n = 2838), 7.1% complained of persistent pain

[24]. Again there was no analysis regarding the de novo

nature of this pain.

Urgency of defecation, at least one year post-proce-

dure, was reported by 5.2% of patients (95% CI: 2.7–8.2%), I2 = 92%, although findings were heterogeneous

and individual cohorts varied from 0% to 34% (Fig. 6).

The European STARR registry reported higher urgency

rates of 20% at 12 months [24] and the German

STARR registry reported rates of 25% at 12 months

[30]. Both groups of authors pointed to poor record-

ing of pre-operative urgency symptoms, relying on the

subset scores from patients’ Symptom Severity Score

(SSS). Schwander et al.[30] suggest that this high

incidence reflected numbers with new onset urgency

with a score of > 1 in SSS, 5.5% had score > 3, and

8% of patients observed a reduction in urgency com-

pared with pre-op. Jayne et al. [24] acknowledged in a

subsequent reply to an invited expert’s analysis of their

paper, that de novo urgency was not recorded in their

registry but 20% of patients reported this as a compli-

cation. Analysis of the subset question in their SSS

suggested that 39.9% of patients experienced urgency

pre-operatively and this fell to 26.8% at 12 months

post-STARR. The highest reported incidence of

urgency came from an RCT (IB) comparing STARR/

PPH01 (34% at 3 years) with Contour Transtar (14%

at 3 years) (P = 0.035) [37]. Urgency was reported as

being de novo in both groups. However, the text in

the results reports that the symptoms resolved in all

but one patient (it is probable that this refers to tenes-

mus which is reported for one patient post-op). The

other RCT (level IB) comparing STARR/PPH01 with

Contour Transtar showed no difference in urgency

rates after 24 months [41].


complications by operation type.





1 Evidence is largely drawn from observational stud-

ies and comparisons. Findings were heteroge-

neous, making estimates tentative and imprecise

(level IV).

2 Overall procedural complication rates ranged from 0%

to 61%. However, these complications may typically

occur in about 13–22% of procedures (level II).

3 The Contour Transtar procedure may feature a

lower overall complication rate although this needs

to be confirmed with better research (level IV).

4 Post-operative bleeding requiring treatment may

typically occur in 1–3% of patients (level II).

5 Post-operative sepsis and anastomotic dehiscence

are rare complications rare typically occurring in less

than 1% of patients (level II).

6 Serious acute post-operative complications are very

rare occurring in about one in a thousand patients

(level II).

7 In the longer term (12 months or more), rectal

stenosis is a rare complication typically occurring in

less than 1% of patients (level II).

8 The most common longer term adverse outcome is

urgency of defaecation, typically occurring in up to

10% of patients (level II).

9 Longer term pain is experienced typically by less

than 2% of patients (level II).

Figure 5 Forest plot showing rates ofbleeding by operation type.




Table 4 Long-term adverse outcomes after rectal excisional procedures.

Author Year N Stenosis

Recto

vaginal

fistula

Recurrent

Prolapse

Pain/

proctalgia > 6

months Dyspareunia

Urgency

after 12

months

(a) PPH01

Boccasanta [15] 2004 25 4 0 0 0 0 0

Boccasanta [16] 2004 90 3.3 0 0 0 0 1.1

Arroyo [18] 2007 17 6 0 6 0 NR 0

Gagliardi [19] 2008 85* 0 0 9.4 1.1 1.1 8.2

Dindo [20] 2008 24 0 0 NR 4.1 0 NR

Lehur [21] 2008 119 0 0 NR 1.8 0 NR

Arroyo [22] 2008 37†† 0 0 5.7 0.9 NR 5.8

Harris [23] 2009 36 0 0 2.7 2.7 10.5 16.7E

Jayne [24] 2009 2224† 0.6 0.04 NR 7.1 0.1 20

Reboa [25] 2009 33 0 0 NR 0 NR 6

Boccasanta [26] 2010 74 1.3 0 0 0 0 2.7

Isbert [27] 2010 68 0 0 2.9 3 NR 4.4

Zhang [28] 2010 50 0 0 2 2 0 2

Madbouly [29] 2010 46 6.5 0 NR 0 NR 0

Schwandner [30] 2010 379 2.1 NR NR 0.5 NR 25.3§§

Ram [31] 2010 30 NR NR NR 0 NR NR

Zehler [32] 2010 20 0 0 NR NR NR NR

Goede [33] 2011 344 2.9 NR NR NR NR 11.5***

Meurette [34] 2011 30 NS NR NR 0 NR 6.8

Patel [36] 2011 37 2.7 NR NR NR 5.4 NR

Boccasanta [37] 2011 50 0 0 12 0 NR 34¶¶

Stuto [38] 2011 2171§ NR NR NR NR NR NR

Song [39] 2011 58 1.7 NR NR 0 NR 0

Ding [40] 2011 86 0 0 NR 0 NR 0

Renzi [41] 2011 30 NR 0 NR NR 3.3 10

Reibetanz [42] 2011 170‡ 0 0 NR 0 NR NR

Naldini [43] 2011 15 NR NR NR NR NR 20

Biviano [8] 2011 30 0 0 3 17 0 6

Savastano [44] 2012 32 6.25 0 NR 0 0 0

Boenicke [46] 2012 181¶ 0 0 NR 0 NR NR

Kohler [47] 2012 80 0 0 5 0 NR 12.5

Hasan [48] 2012 40 0 0 0 2.5 NR 2.5

Adams [50] 2013 37 2.7 0 5.4 NR NR NR

Zhang [53] 2013 75 0 0 4 NR NR 1.3†††

Panicucci [54] 2014 54** NR NR NR NR NR 7.4

Borie [55] 2014 25 0 0 NR NR 12‡‡ NR

Leardi [58] 2014 51 0 0 2 NR NR 0

(b) PPH03

Arroyo [18] 2007 20 0 0 5 0 NR 0

Arroyo [22] 2008 67‡‡‡ 0 0 5.7 0.9 NR 5.8

Jiang [45] 2012 43 0 0 NR 2 NR NR

Gentile [57] 2014 30 NR NR NR NR 16.6 NR


Lenisa [3] 2009 75 0 0 NR 0 NR 13

Isbert [27] 2010 82 0 0 0 3 NR 4.8

Martellucci [35] 2011 133 0 0.8 NR 1.5 NR 6.8

Boccasanta [37] 2011 50 0 0 0 0 0 14

Renzi [41] 2011 31 NR NR NR NR 0 9.6

Naldini [43] 2011 15 NR NR NR NR NR 13




10 Rectovaginal fistula is a very rare longer term

complication, occurring in about one in about one

in every one thousand six hundred patients (level

II).

11 There was insufficient evidence to establish whether

specific post-operative or longer term complications

varied between procedures (level IV).

12 In all studies where mortality was recorded, there

were no deaths in a total of 5896 patients studied

(level II).

Efficacy

Measurement of clinical outcome was consistently

recorded in many studies using a variety of the available

subjective summative scoring instruments for constipa-

tion symptoms (Table 6). These included the Cleveland

Clinic Constipation Score (21 studies), obstructed defe-

cation syndrome (ODS) score (30 studies), Symptom

Severity Score (SSS) (eight studies).

The Longo scoring system for ODS was reported for

56% of cohorts. Reduction in ODS occurred in 72.2%

of patients (95% CI: 68.5–75.8%), I2 = 83% (Fig. 7).

There was considerable heterogeneity between findings,

which varied from 53–91% and may reflect multiple

causes. Although findings are imprecise, there was no

robust evidence that one procedure produced greater

score reductions than another. Improvement in consti-

pation was reported in all studies where it was recorded.

In many publications regarding surgical treatment of

constipation, success has been defined as > 50%

improvement in objective scores. A total of 18/21 stud-

ies reported > 50% improvement in CCS; all studies

(30/30) reported > 50% improvement in ODS; 5/8

studies reported > 50% improvement in SSS. Significant

improvement in ODS was seen in both arms of the two

RCTs (IB) comparing STARR (PPH01) and Contour

Transtar [37,41] and in the other level IB RCT com-

paring STARR with PPH01 and mucosectomy (with

PPH01) together with levatoroplasty [15]. Whilst this


Author Year N Stenosis

Recto

vaginal

fistula

Recurrent

Prolapse

Pain/

proctalgia > 6

months Dyspareunia

Urgency

after 12

months

Savastano [44] 2012 32 0 0 NR 0 0 3.2

Masoni [51] 2013 187 0 0.5 NR NR NR 0

Bock [52] 2013 70 0 NR 8.6 NR NR 0

Ribaric [56] 2014 100 0 0 NR 1 NR 3


Liberman [14] 2000 34 3 0 3 0 NR NR

Pescatori §§§ [17] 2006 26 7.5 0 35 2.5 NR NR

Ganio [49] 2013 167 ¶¶¶ 1.8 0 5.4 2.4 NR NR

Gentile [57] 2014 36 NR NR NR NR 11.1 NR

NR, not recorded.


*Report on 123 patients, but only 85 operated on.

†Report on 2838 patients for complications, 2224 reached 12 months follow-up.

‡101 patients had Countour Transtar.

§208 patients had Contour Transtar

¶Some patients had Contour Transtar

**18 patients had Contour Transtar.

††Complications are reported for 104 patients (67 had PPH03).

‡‡Not stated if de novo.

§§This reflects numbers with score of > 1 in Symptom Severity score, 5.5% had score > 3, and 8% of patients observed a reduction

in urgency compared with pre-op.¶¶Table refers to this incidence at 3 years, however text reports that all urgency resolved in all but one patient.

***Authors report that 74% of patients had pre-op urgency.

†††Uncertain if this is de novo.

‡‡‡Complications are reported for 104 patients (37 had PPH01).

§§§These percentages are based upon analysis of 40 patients (14 patients having had PPH01 or PPH01 with manual mucosec-

tomy).

¶¶¶91 patients also had levatoroplasty.




improvement was maintained at three years, without

difference between procedures in one trial [37], in the

other at 24 months the improvement was maintained in

the Contour Transtar group but not in the STARR

group and there was a significant difference in scores

between the two groups [41]. In the other two RCTs

of lesser quality (IIB), STARR (PPH01) was shown to

be significantly better for functional outcome compared

with biofeedback (although there was > 50% attrition

rate in the biofeedback group) [21], and STARR

(PPH01) was shown to give similar functional results

compared with Intra-anal Delorme’s with levatoroplasty

[57]. In other non-randomised (level IIB) comparisons

of STARR (PPH01) vs Contour Transtar [8,27,43]

there was no difference in functional outcome. One

prospective cohort study (level IIB) compared PPH01

with PPH03 [18] and showed no difference in func-

tional outcome, and a further compared STARR with

macrogol therapy [8]. There was no difference in out-

come when looking at response rates, however it was

unclear if groups were matched and no report on differ-

ent laxative use was included in inclusion criteria. One

would normally assume that macrogol or other medical

management would have been tried before selecting a

patient for a rectal excisional procedure.

The effect of time post-procedure and efficacy was

examined in the four level I/IIB studies with a follow-

up of > 30 months [8,37,53,57]. Three studies showed

greater than 75% reduction in subjective scores

[8,37,57] and the other greater than 50% reduction,

regardless of the procedure provided.

Global ‘success’ or ‘satisfaction’ ratings (GSR) were

obtained via a variety of methods in 28 of 55 cohorts

(Table 5), where ‘satisfied’ or ‘very satisfied’, ‘good’,

‘very good’ and ‘excellent’ were interpreted as positive

outcomes. Further studies also reported individual

symptoms. No study reported acquiring data objectively

using personnel not involved in the surgical care of the

patient or data collection blind to intervention status.

Most reports assert that the majority of patients

Figure 6 Forest plot showing rates ofrectal urgency after 12 months by

operation type.




undergoing PPH01, PPH03, Contour Transtar, and

intra-anal Delorme’s procedure were satisfied. Random

effects meta-analysis found the global satisfaction rating

to be 76.3% (95% CI: 72.8–79.5%), I2 = 59% (Fig. 8).

There was considerable heterogeneity between findings,

which varied from 51% to 90% and may reflect multiple

causes. Although findings are imprecise there was no

evidence that one procedure produced higher levels of

satisfaction than another.

Disease-specific and generic QoL scoring instruments

were used less often including PAC QoL (11 studies,

data not shown), EQ-VAS (six studies, data not

shown), EQ-5D (two studies, data not shown), FIQL

(one study, data not shown). Using such instruments,

improvements in QoL were associated with symptom

improvements in most studies except for Ribaric et al.

[56] who showed non-significant improvements in EQ-

5D and EQ VAS in 100 patients 12 months after Con-

tour Transtar and Madbouly et al. [29] who, reporting

on 46 patients after PPH01, showed significant

improvements in PAC QoL at 18 months but not at

42 months.

The aim of rectal excision procedures is to enable

normal evacuation and assessment of constipation symp-

toms is therefore the most important outcome. How-

ever, many patients also suffer from incontinence, either

as a result of neurogenic/traumatic sphincter patholo-

gies or from the effects of a high grade recto-anal intus-

susception. Instrumented excisional procedures are

postulated to increase the risk of faecal incontinence by

their very nature. Indeed one of the exclusion criteria in

many studies was greater than minor faecal incontinence

(Table S1). Objective scores (Wexner or St Marks

incontinence score, FISI) when reported (Table 6)

showed either no change or reduction in scores other

than in one study where an increase was reported [47].

In this study after PPH01, the median Wexner inconti-

nence score rose from 3.3 to 5.5 after 2–3 years. It was

reported that a third of patients developed incontinence

symptoms 1–4 years after the procedure.

While anatomical outcome is necessarily only a surro-

gate of clinical outcomes, recurrent prolapse was

reported for less than half of cohorts and occurred in

4.3% of patients (95% CI: 2.0–7.3%), I2 = 78%. Again

findings were heterogeneous and there was no robust

evidence that one procedure was associated with higher

long term adverse outcomes than another. One RCT

comparing STARR with Contour Transtar reported that

at three years post-procedure 12% of STARR patients

had a clinical recurrence compared with none of the

Contour Transtar patients (P = 0.035) [37]. The

weight of resected tissue was significantly greater in the

Transtar group.


1 Data on efficacy were inconsistently measured and



2 Although inconsistent, patient global satisfaction rat-

ings typically suggest (at least) satisfactory outcome

in about 73–80% of patients (level II).

3 Although inconsistent, a reduction of 53–91% in

Longo scoring system for obstructive defecation syn-

drome occurred in about 68–76% of patients (level II).

Table 5 Percentage success based on global satisfaction ratings

(GSR).

Author Year N FU mean GSR %*

(a) PPH01

Boccasanta [15] 2004 25 23 88

Boccasanta [16] 2004 90 16 90

Dindo [20] 2008 24 18 83

Isbert [27] 2010 68 12 80

Reboa [25] 2009 33 18 75.7

Zehler [32] 2010 20 66 80

Goede [33] 2011 344 12 81

Patel [36] 2011 37 20 71.9

Boccasanta [37] 2011 50 36 66

Song [39] 2011 58 34 63.4

Renzi [41] 2011 30 36 60

Biviano [8] 2011 30 38 60

Kohler [47] 2012 80 39 77.5

Hasan [48] 2012 40 12 75

Adams [50] 2013 37 13 50

Zhang [53] 2013 75 30 64

Panicucci [54] 2014 54 † 12 87

Borie [55] 2014 25 18 84

Leardi [58] 2014 51 36 81

(b) PPH03

Jiang [45] 2012 43‡ 12 72

Gentile [57] 2014 30 12 73§


Lenisa [3] 2009 75 12 77.3

Isbert [27] 2010 82 12 81.5

Martellucci [35] 2011 133 19 69.8

Bock [52] 2013 70 48 87


Liberman [14] 2000 34 43 76.4

Ganio [49] 2013 167 36 78.2¶

Gentile [57] 2014 36 12 73**

*Proportion good or excellent.

†18 patients had Contour Transtar.

‡linear stapler.

§GSR is based on 66 patients (36 had intra-anal Delorme’s).

¶91 patients also had levatoroplasty.

**GSR is based on 66 patients (30 had PPH03).




Table 6 Functional outcomes by procedure.

Author Year N FU‡‡

% reduction

in CCS

% reduction

in Longo/

ODS score

% reduction

in SSS score

Any significant

increase or

decrease in

FI scores

(a) PPH01

Boccasanta [15] 2004 25 23 68.6 \ \ N

Boccasanta [16] 2004 90 16 65.3 \ \ N

Arroyo [18] 2007 17 24 \ \ 68 \

Gagliardi [19] 2008 85 * 17 \ \ \ \

Dindo [20] 2008 24 18 54.5 \ \ \

Lehur [21] 2008 119 12 \ 71 \ \

Arroyo [22] 2008 37†† 26 62.3 \ \ \

Boccasanta [26] 2010 74 24 \ 88.4 \ \

Harris [23] 2009 36 12 \ 88 \ \

Isbert [27] 2010 68 12 46.8 65.5 \ N

Jayne [24] 2009 2224† 12 \ 67.3 76.1 Decrease

Reboa [25] 2009 33 18 72.4 \ \ \

Zhang [28] 2010 50 12 63.5 66.3 70.3 \

Madbouly [29] 2010 46 42 \ 75.3 \ \

Schwandner [30] 2010 379 12 \ \ 49.4 N

Ram [31] 2010 30 26 \ \ \ \

Zehler [32] 2010 20 66 \ 65 40 Decrease

Goede [33] 2011 344 12 \ 89 \ Decrease

Meurette [34] 2011 30 48 \ 58.6 \ N

Patel [36] 2011 37 20 \ 58.6 \ \

Boccasanta [37] 2011 50 20 \ 83 \ N

Stuto [38] 2011 2171§ 12 \ 70 \ Decrease

Song [39] 2011 58 34 58.5 \ \ \

Ding [40] 2011 86 12 \ 60.5 \ N

Renzi [41] 2011 30 36 \ 59.6 \ \

Reibetanz [42] 2011 170‡ 18 47 \ \ \

Naldini [43] 2011 15 24 \ 73.4 \ \

Biviano [8] 2011 30 38 76.1 \ \ \

Savastano [44] 2012 32 27 \ 87 \ \

Boenicke [46] 2012 181¶ 19 58.9 \ \ N

Kohler [47] 2012 80 39 54.8 \ \ Increase

Hasan [48] 2012 40 12 83.8 \ \ \

Adams [50] 2013 37 13 \ \ \ \

Zhang [53] 2013 75 30 54.6 53.5 \ N

Panicucci [54] 2014 54 ** 12 68.5 74.4 \ \

Borie [55] 2014 25 18 \ 59 \ \

Leardi [58] 2014 51 36 \ 76 \ Decrease

(b) PPH03

Arroyo [18] 2007 20 24 \ \ 68 \

Arroyo [22] 2008 67R 26 62.3 \ \ \

Jiang [45] 2012 43 12 62.9 \ \ \

Gentile [57] 2014 30 12 \ \ \ \


Lenisa [3] 2009 75 12 \ 83 50.2 N

Isbert [27] 2010 82 12 50 68 \ N

Martellucci [35] 2011 133 19 48 \ \ \

Boccasanta [37] 2011 50 36 \ 85 \ N

Renzi [41] 2011 31 24 \ 64.5 \ \




4 Evidence for longer term benefits persisting from

procedures is sparse but suggests improvements may

be maintained (level II).

5 Findings from efficacy measures provided insufficient

evidence to recommend one type of procedure over

another (level IV).

6 The use of Contour Transtar increases the amount of

resected tissue and may reduce recurrence rates

although this requires further study (level IV).

7 There is no evidence that rectal excisional procedures

contribute towards post-operative faecal incontinence

(level II).

8 Recurrent prolapse occurred in 4.3% of patients con-

sidering all studies (level IV); rates were lower (1.7%)

in higher quality studies (level II).

Variation in outcomes by level of evidence

Meta-analytic findings are reported for each of the out-

comes reported, subdivided by level of evidence

(Table 7). Recurrent prolapse was the only adverse out-

come where findings varied by grade of evidence: grade

IB/IIB: 1.7% of patients (95% CI: 0.4–3.7%), I2 = 54%,

and grade IV: 9.2% of patients (95% CI: 4.1–15.9%),I2 = 78%.

Patient selection

Patient selection is generally perceived to be essential

when choosing a surgical approach. Whilst rectal exci-

sion procedures may be efficient at correcting normal

anatomy, there may be many underlying functional and

organic pathologies that mean surgery is unsuccessful at

‘curing’ the patient [59]. It is advised when contem-

plating a surgical approach to exhaust first all forms of

conservative or medical management. Forty-one out of

55 cohorts studied highlight the fact that all patients

had undergone a period of conservative management

(Table 7).

Many of the current studies reference inclusion and

exclusion criteria based upon a previous consensus con-

ference [60], namely that patients should be selected on

the basis of recognized symptoms of ODS with evi-

dence of anatomical defects on defaecography (recto-

coele and/or internal rectal prolapse) and adequate anal

sphincter function (at least assessed by digital rectal


Author Year N FU‡‡

% reduction

in CCS

% reduction

in Longo/

ODS score

% reduction

in SSS score

Any significant

increase or

decrease in

FI scores

Naldini [43] 2011 15 24 \ 69.9 \ \

Savastano [44] 2012 32 27 \ 90.3 \ \

Masoni [51] 2013 187 12 67 \ \ \

Bock [52] 2013 70 48 \ 56.3 46.7 N

Ribaric [56] 2014 100 12 \ 64.7 \ N


Liberman [14] 2000 34 43 \¶¶ \ \ N

Pescatori [17] 2006 26 36 \ \ \ \

Ganio [49] 2013 167 *** 36 66.7 63.5 \ N

Gentile [57] 2014 36 12 \ \ \ \

N, no change; \, not recorded; FI, faecal incontinence.



†Report on 2838 patients, but 2224 reached 12 months follow-up; complete data for ODS score (41%), complete data for SSS (57%).


§208 patients had Contour Transtar, 1485 patients completed 12 months follow-up.

¶Some patients had Contour Transtar.


††Complications are reported for 104 patients (67 had PPH03).

‡‡Mean follow-up in months.

§§This study also showed a significant improvement in the Knowles-Eccersley-Scott-Symptom (KESS) score.

¶¶67–93% of patients showed improvement in 4 of CCS domains.

***91 patients also had levatoroplasty.




examination). In 42 out of the 55 cohorts studied,

patients had at least 3 ODS symptoms (Table 8). In

general when selecting patients for functional surgery it

has also been advised to select patients with a high

symptom load [61]. A criticism made to the authors of

the European STARR Registry (n = 2224) was that the

median ODS score was low (15.7 out of a possible 40)

and that the range was high (1–31) [24]. The two level

I RCTs reported inclusion criteria of an ODS score

> 12 in one [41] and 15 in the other [37]. The major-

ity of studies reported an inclusion criterion of rectal

intussusception and/or rectocoele, (38 out of 55 study

groups). Thirty-two out of the 55 study groups

reported a rectocoele > 2 cm, and in 26 of these, more

than 75% of patients had a rectocele > 2 cm. Thirty-

seven out of the 55 study groups reported on recto-rec-

tal or recto-anal intussusception, and in 28 of these

more than 60% of patients had an intussusception. Mul-

tiple classifications were used for diagnosing an intussus-

ception including Pescatori [62], Shorvon [63], and

Oxford [64]. Other studies stated that inclusion

required a rectal intussusception greater than 10 mm

[41] or recto-anal intussusception > 10 mm [31]. One

study reported on outcome at five years following

PPH01 for patients with a symptomatic rectocoele

when the authors specifically excluded intussusception

[32]. This study found an 80% satisfaction rate at one

year, which remained at five years. It was not possible

to draw conclusions regarding efficacy according to

either the presence of an intussusception (whichever

grade/stage) or rectocoele size.

It is pertinent to discuss exclusion criteria as this may

influence the surgeon in their choice of procedure (rein-

forcement/suspension/excision). Reference was again

made in many studies to the consensus statement [60]

and a decision making algorithm for STARR [65] when

defining exclusion criteria. Specifically, external rectal

prolapse, solitary rectal ulcer syndrome (SRUS),

anatomical enterocele, and ‘significant gynaecological

pelvic floor abnormality requiring treatment’ were

Figure 7 Forest plot showing reduction

in Longo’s obstructed defacation

syndrome (ODS) score by operation

type.




stated as exclusions. Less than 50% of the reviewed

studies excluded external rectal prolapse or other pelvic

organ prolapse, and no study excluded SRUS

(Table S1). Only one study graded pelvic organ pro-

lapse (rectocoele, cystocoele, vault, uterine) with a stan-

dardized grading system e.g. POP-Q (data not shown)

[26]. Whilst it is sensible to exclude patients with exter-

nal rectal prolapse, no conclusion can be made regard-

ing excluding patients with SRUS, or concomitant

pelvic organ prolapse.

Anatomical enterocoele is generally regarded as a

contraindication to an anterior rectal wall excision

[60,65], however many studies did not exclude this

(Table S1). Irrespective of this, there were no cases of

iatrogenic small bowel injury reported. One study

examined the outcome with respect to harms in

patients with a functional enterocoele, and those with-

out [42]. All patients had either PPH01 or Contour

Transtar and outcomes with respect to harms were

similar.


1 Patient selection, although perceived as vital in pre-

dicting outcome, is inconsistently documented and

poorly informed by current evidence (level IV).

2 Patients with at least three ODS symptoms together

with a rectocoele with or without an intussusception,

who have failed conservative management may bene-

fit from a rectal excisional procedure (level II).

3 It is not possible to advise on excluding patients with

concomitant pelvic organ prolapse or SRUS when

considering a rectal excisional procedure (level IV).

Conclusions


and long term benefits and harms of rectal excisional

procedures identified a modest number of high quality

studies together with a larger number of observational

lesser quality studies. Whilst the evidence is superior to

the level of evidence for other procedures for

Figure 8 Forest plot showing global

satisfaction rating (%) by operation type.




constipation it is still rather poor in the field of medi-

cine systematic reviews. Notwithstanding this, certain

conclusions can be drawn:

1 In the presence of a rectocoele with or without an

intussusception, together with at least three symp-

toms of ODS, a rectal excisional procedure may ben-

efit the patient after all conservative measures have

been exhausted.

2 Reliance on proving efficacy using GSR and unvali-

dated scoring systems (Longo) is not satisfactory and

greater emphasis should be placed in future studies

on the use of disease-specific and generic QoL scor-

ing instruments.

3 It is not possible to advise which excisional technique

is superior from the point of view of efficacy, peri-

operative variables, or harms (peri-operative or long

term adverse outcomes). Future study is required.

4 Both short- and long-term harms may have been

exaggerated in previous reports. Rectal excisional

procedures appear to be safe with little major mor-

bidity. Rectal urgency appears to be a problem, but

findings are inconsistent because of poor reporting.

5 Despite evidence of mixed grade (IB, IIB and IV)

being available for rectal excision procedures, there

was little evidence that outcomes varied by grade of

evidence. Recurrent prolapse was the only adverse

outcome where findings varied by grade of evidence

and thus may be a chance finding in the absence of

any systematic pattern across outcomes.

Acknowledgements




























Table 7 Outcomes by level of evidence.

IB/IIB IV Combined

IB/IIB

vs IV

Effect size (95%CI), I2 Effect size (95%CI), I2 Effect size (95%CI), I2 p

Perioperative data

Procedure duration (mins) 44.3 (39.9–48.7), 99.2% 44.4 (35.4–53.5), 99.5% 44.3 (40.5–48.1), 99.5% 0.98

Length of stay (days) 2.8 (2.5–3.2), 98.1% 3.6 (2.5–4.7), 98.7% 3.0 (2.6–3.4), 98.8% 0.18

Total complication rate (%) 13.5% (8.3–19.6%), 94.0% 22.0% (15.9–28.7%), 85.5% 16.9% (12.7–21.5%), 92.6% 0.052

Perioperative harm

Bleeding rate (%) 1.5% (0.7–2.4%), 52.7% 2.2% (0.6–4.3%), 72.4% 1.6% (0.9–2.5%), 63.0% 0.56

Sepsis rate (%) 0.0% (0.0–0.5%), 67.1% 0.8% (0.0–2.2%), 48.8% 0.2% (0.0–0.7%), 62.6% 0.090

Anastomotic

dehiscence rate (%)

0.2% (0.0–0.9%), 67.3% 0.2% (0.0–0.9%), 11.2% 0.3% (0.0–0.8%), 61.6% 0.98

Long term adverse outcomes

Rectal stenosis (%) 0.1% (0.0–0.5%), 24.4% 0.4% (0.0–1.2%), 36.4% 0.2% (0.0–0.6%), 30.3% 0.52

Rectal pain (%) 0.6% (0.0–1.9%), 83.6% 0.8% (0.1–1.8%), 0.0% 0.7% (0.1–1.6%), 78.7% 0.76

Rectal urgency (%) 5.6% (2.7–9.3%), 90.7% 4.2% (0.9–9.2%), 89.1% 5.2% (2.7–8.2%), 91.8% 0.51

Rectal prolapse (%) 1.7% (0.4–3.7%), 53.9% 9.2% (4.1–15.9%), 82.0% 4.3% (2.0–7.3%), 78.7% 0.006

Efficacy

Global satisfaction

rating (%)

76.4% (71.3–81.1%), 59.0% 76.0% (71.1–80.7%), 62.4% 76.3% (72.8–79.5%), 59.0% 0.94

Longo ODS (%) 71.9% (68.5–75.1%), 70.7% 71.3% (58.0–83.0%), 90.9% 72.2% (68.5–75.8%), 83.2% 0.93




Table 8 Inclusion criteria for procedures.

Author Year N

Rectocele

> 2 cm %

Recto-rectal /

Recto-anal

Intussusception %

Rectocele +

Intussusception %

Failure of

conservative RX

At least 3

ODS symptoms

(a) PPH01

Boccasanta [15] 2004 25 100 100 100 Yes Yes


Arroyo [18] 2007 17 92 27 NR Yes Yes

Gagliardi [19] 2008 85* 80 93 73 Yes Yes

Dindo [20] 2008 24 79 83 NR Yes Yes

Lehur [21] 2008 119 92 61 NR No Yes

Arroyo [22] 2008 37†† NR NR NR Yes Yes


Harris [23] 2009 36 81 39 39 No Yes

Isbert [27] 2010 68 100 80 80 Yes Yes

Jayne [24] 2009 2224† 99 80 NR Yes Yes

Reboa [25] 2009 33 67 97 NR Yes Yes

Zhang [28] 2010 50 NR NR NR No No

Madbouly [29] 2010 46 59 41 NR Yes Yes

Schwandner [30] 2010 379 NR NR NR No Yes

Ram [31] 2010 30 67 13 67 No Yes

Zehler [32] 2010 20 100 0 0 Yes Yes

Goede [33] 2011 344 NR 100 NR No Yes

Meurette [34] 2011 30 100 100 100 Yes No

Patel [36] 2011 37 100 81 81 Yes Yes

Boccasanta [37] 2011 50 100 100 100 No Yes

Stuto [38] 2011 2171§ 82 95 NR No Yes

Song [39] 2011 58 62 80 NR Yes Yes

Ding [40] 2011 86 90 94 77 Yes Yes

Renzi [41] 2011 30 NR NR NR Yes Yes

Reibetanz [42] 2011 170‡ NR NR NR No No

Naldini [43] 2011 15 NR NR NR Yes Yes

Biviano [8] 2011 30 77 50 NR Yes Yes

Savastano [44] 2012 32 NR NR NR No No

Boenicke [46] 2012 181¶ NR NR 100 Yes Yes

Kohler [47] 2012 80 100 100 NR No Yes

Hasan [48] 2012 40 90 55 NR Yes Yes

Adams [50] 2013 37 NR NR NR Yes Yes

Zhang [53] 2013 75 NR 87 NR Yes No

Panicucci [54] 2014 54 ** NR NR NR Yes Yes

Borie [55] 2014 25 100 65 65 Yes Yes

Leardi [58] 2014 51 43 57 0 Yes No

(b) PPH03

Arroyo [18] 2007 20 92 27 NR Yes Yes

Arroyo [22] 2008 67§§ NR NR NR Yes Yes

Jiang [45] 2012 43 100 56 56 Yes Yes

Gentile [57] 2014 30 NR NR NR Yes No


Lenisa [3] 2009 75 NR NR NR Yes Yes

Isbert [27] 2010 82 100 65 65 Yes Yes

Martellucci [35] 2011 133 NR NR NR Yes Yes

Boccasanta [37] 2011 50 100 100 100 No Yes

Renzi [41] 2011 31 NR NR NR Yes Yes










Foundation Trust.

Funding







ment of Health.


M Mercer-Jones has no conflict of interest in relation

to the content of the manuscript. In the last 2 years

he has received fees as a preceptor for Medtronic Inc.

C.H.Knowles has no conflict of interest in relation to

the content of the manuscript. In the last 2 years he

has recieved speaker fees and consultancy payments

from Medtronic Inc. remaining authors no conflict.

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Supporting Information

Additional Supporting Information may be found in the

online version of this article:

Figure S1. Forest plot showing rates of sepsis by opera-

tion type.

Figure S2. Forest plot showing rates of anastomotic

dehiscence by operation type.

Table S1. Exclusion tables. (a) PPH-01; (b) PPH03;

(c) Contour Transtar; (d) Intra-anal.





Results IV: Recto-vaginal reinforcement procedures

U. Grossi*, E. J. Horrocks*, J. Mason†, C. H. Knowles*, A. B. Williams‡, on behalf of the NIHR

CapaCiTY working group§ and The Pelvic floor Society¶*National Bowel Research Centre, Blizard Institute, Queen Mary University of London, London, UK, †Health Economics, University of Warwick,

Coventry, UK, ‡Guy’s and St Thomas’ NHS Foundation Trust, London, UK, §National Institute for Health Research: Chronic Constipation Treatment

Pathway, London, UK, and ¶Affiliate section of the Association of Coloproctology of Great Britain and Ireland, London, UK

Abstract

Aim To assess the outcomes of recto-vaginal reinforce-

ment procedures in adults with chronic constipation.







Results Forty-three articles were identified, providing

data on outcomes in 3346 patients. Average length of

procedures ranged between 20 and 169 min, and

length of stay between 1 and 15 days. Complications

typically occurred after 7–17% of procedures (range 0–61%). Post-operative bleeding was uncommon (0–4%)as well as haematoma or sepsis (0–2%). Fistulation did

not occur in most studies. Two procedure-related

deaths were observed for 3209 patients. Although

inconsistent, 78% of patients reported a satisfactory or

good outcome, with 30–50% experiencing reduced

symptoms of straining, incomplete emptying or reduced

vaginal digitation. About 17% of patients developed

anatomical recurrence. Considering measures of harm

and global satisfaction rating scales, there was insuffi-

cient evidence to prefer one type of procedure over

another. There was no evidence to support better out-

comes based on selection of patients with a particular

size or grade of rectocoele.

Conclusion Evidence supporting recto-vaginal rein-

forcement procedures is currently derived from observa-

tional studies and comparisons, with only one high

quality study. Large trials are needed to inform future

clinical decision making.

Keywords Recto-vaginal reinforcement, constipation,

rectocele, STARR, transvaginal repair, transanal repair

Introduction


Chronic constipation is related to an inability to evacu-

ate the rectum in over half of all adults presenting for

specialist advice. This phenomenon, which may be vari-

ably described as obstructed defaecation or rectal evacu-

ation disorder (and many other terms), is characterised

by excessive straining, the feeling of incomplete evacua-

tion, post-defaecatory seepage and often mucous dis-

charge, and pelvic pain [1]. In some of these patients

there is clinical and radiological (usually proctographic)

evidence of a dynamic structural abnormality leading to

physical impediment to emptying during defaecation.

By far away, the way most common abnormalities are

rectocoele and/or intussusception.

Traditionally a rectocoele may be considered either a

bulge into the vagina, giving vaginal prolapse symp-

toms, or the sensation of a lump or mass. Also, a herni-

ation of the rectum into the vagina preventing complete

evacuation may lead to ‘trapping’ of faeces in the

‘pocket’ and subsequent incomplete evacuation (bal-

looning may also lead to loss of vector forces along the

anorectal axis). This process can lead to dissatisfaction

with emptying and repeated visits to the toilet, post-

defaecatory soiling and the need to apply pressure to

the posterior vaginal wall or perineum to splint the rec-

tocoele and maximise emptying. Many women will also

‘digitate’ or manually assist emptying using a finger

Correspondence to: Andrew B. Williams, Consultant Colorectal and General

Surgeon, Guy’s and St Thomas’ NHS Foundation Trust, St Thomas’ Hospital,

Westminster Bridge Road London, SE1 7EH UK.








either in the rectocoele via the anus to aid with com-

plete emptying or in the vagina to splint against the

posterior vagina to prevent trapping and direct evacua-

tory forces down along the axis of the anus.

It follows that strategies have been employed to

anatomically correct a rectocele by reinforcing the barrier

between the rectum and vagina (rectovaginal septum).

Access for rectovaginal reinforcement varies with three

main approaches described: the posterior vagina (poste-

rior repair [2]), the perineum (transperineal repair [3]),

or via the anus (transanal repair [4,5]). Vaginal repairs all

involve an incision in the posterior wall either longitudi-

nally to open the entire length of the rectocoele or trans-

versely to produce a broad based flap and expose the

entirety of the rectocoele, or a combination of the two

incisions in the shape of an inverted ‘T’. In most repairs

the redundant rectal wall is plicated outside the bowel

wall. The vaginal wall is then reconstructed with resec-

tion of any excess vaginal mucosa. Many repairs include

some degree of approximation of the levator ani and pel-

vic side wall muscles to formally reinforce the reconstruc-

tion of the rectovaginal septum, although with the

reputed higher risk of dyspareunia. More recently

attempts have been made to localise specific defects in

the rectovaginal septum. This has led to ‘site specific’

repairs [6,7], where the individual defects are repaired

before the vaginal wall is closed. All of these types of

repairs may be augmented by mesh reinforcement, usu-

ally using one of a variety of collagen meshes.

The rectovaginal septum may be entered through a

transperineal route. A transverse or curved incision is

made in the perineal body towards the vagina and the dis-

section extended anterior to the sphincter complex to gain

access to the rectovaginal septum. Having gained expo-

sure, a repair is made in the same way as in a transvaginal

approach. The potential advantage to this route is that it

may be combined with a sphincteroplasty in those women

with a deficient sphincter and a concurrent rectocoele.

Finally, a rectocoele can be considered as a redundant

pocket of rectum, rather than a weakness in the rectovagi-

nal septum leading to herniation of the rectum. A transa-

nal repair addresses the rectal redundancy with either an

anterior Delorme’s style repair (Sarle’s repair [5]) or with

a sutured pexy of the anterior rectal wall (Block repair

[4]). In the former repair, the mucosa is dissected free

from the rectal muscle and excised. Following this, the

rectal muscle coat is plicated longitudinally to obliterate

the rectocoele pocket and the mucosa is re-approximated

to close the defect. In the Block repair, full thickness lon-

gitudinal sutures are placed anteriorly to draw together

the redundant anterior rectal pocket and close the recto-

coele. It is evident that these procedures necessitate a

degree of rectal wall excision or suspension respectively.

Scope

The overall purpose of the CapaCiTY review series is to

assess the efficacy and harms of procedures for chronic

constipation in adults. The focus is therefore directed to

a population presenting with symptoms of obstructed

defecation, rather than women with only prolapse, uri-

nary symptoms or both (see overview and methods

paper). One group of procedures considered beyond

the scope of this systematic review included those where

excision is effected without reinforcement, e.g. rectal

excision only, such as stapled transanal resection of the

rectum (STARR). As is noted above, anterior Delorme’s

or Sarle’s procedures are included, which include a

degree of resection, but also have an significant element

of reinforcement with muscle wall plication (targeted at

the rectovaginal plane), which is not present in pure

resection. This noted, a small number of studies have

specifically focused stapled resection to the obliteration

of a rectocele by anterior deployment of a stapler to

exact mucosal excision (much like stapled haemor-

rhoidopexy). In a sense, these reinforce the RV septum

by tightening tissue and have been included for comple-

tion in this review. Further, most compare this

approach with one of the other approaches also covered

in this review. The separate review covering rectal exci-

sion includes numerous studies of STARR in which the

device is used to excise circumferential full-thickness

excision and the reviews overlap in only one study [8].

Circumferential Delorme’s procedures are excluded

from this review as their focus is not on reinforcement

of the rectovaginal septum but rather on general resec-

tion for prolapse (covered in rectal suspension review).

Studies where outcomes could not be segregated by eli-

gible procedure were also excluded, due to a mixed

patient population with internal and external rectal pro-

lapse, mixed indications including numerous pelvic floor

abnormalities or limited postoperative outcomes.

Previous reviews

There have been no systematic reviews of the results of

rectocoele repair for the treatment of obstructed defae-

cation or constipation. There has been a systematic

Cochrane review (with updates) on the surgical man-

agement of pelvic organ prolapse in women [9–13],which includes review of posterior vaginal repair for rec-

tocoele. This review included seven randomised trials

on women with posterior vaginal wall prolapse [3,14–19], three trials comparing vaginal and transanal

approaches [3,14,18]. In addition, another trial pro-

vided data for women with rectocele undergoing poste-

rior repair with and without absorbable mesh [16].



Recto-vaginal reinforcement for constipation U. Grossi et al.

There has been one systematic review of the use of bio-

logics in urogynaecological repairs [20]. In addition,

the International Continence Society, 5th International

Consultation on Incontinence, Paris, February 2012,

pages 1411–1414 [21], covers posterior repair. Neither

this, nor the Cochrane process focussed on the specific

management of patients with constipation.


The search yielded a total of 72 citations for full text

review (Fig. 1). From these, 44 articles published

between 1990 and 2016 contributed 43 studies to the

systematic review (one cohort was spread across two

publications with a focus on perioperative morbidity

[22] and clinical outcomes [23], respectively). Data on

outcomes were provided for a total of 3346 patients

(study mean: 78, range 13–307) (Table 1). Specific

exclusions after full-text review (and after exclusion of

five non-English language publications) included: four

studies where the population sample was confirmed to

be <20 patients; eight studies where follow up was less

than 12 months; two studies of out of scope proce-

dures; four studies where data were considered as dupli-

cate; three studies where outcomes could not be

segregated by eligible procedure; and two studies with

no relevant outcome data.

The quality of studies varied. The 43 included stud-

ies included three randomised controlled trials (RCTs)

and 40 observational studies. The former included one

good quality RCT (level IB) with a low level of suscep-

tibility to bias and two with less well described method-

ology (level IIB). The 40 observational studies included

eight good quality cohort studies with low susceptibility

to bias (level IIB). Other studies were a mix of prospec-

tive and retrospective case series. Mean study follow-up

was 2.1 years (range 0.7–6.2 years); 19 studies origi-

nated from European centres, 12 from the USA and 12

from other countries. The studies covered the full spec-

trum of types of repair and are shown in Fig. 2.

Results

Perioperative data

The 43 studies included 62 patient cohorts receiving one

of eight procedures (Table 2). Perioperative data were

reported inconsistently by studies, with 24 (39%) cohorts

reporting average procedural duration and 29 (47%)

reporting average length of stay (Tables 2 and 3). There

was considerable variation in these measures when com-

paring procedures: design heterogeneity, small numbers

of studies and large range of values precludes any clear

pattern. The overall average duration of procedures was

67 (range 20–169) minutes, and the overall average

length of stay was 3.9 (range 1–15) days.


• The average duration of procedures was about one

hour, although this is inconsistently reported and ran-

ged widely between studies from 20 to 169 min

(level IV).

• The average length of stay was about 4 days although

this is inconsistently reported and ranged widely

between studies from 1 to 15 days (level IV).

• There was inadequate evidence to determine varia-

tions in procedural duration or length of stay by type

of procedure (level IV).

Figure 1 PRISMA diagram of searchresults.



U. Grossi et al. Recto-vaginal reinforcement for constipation


Authors Year Centre Country N FU (months) Design Grade*

Arnold [24] 1990 Columbus, OH USA 64 24 RCS IV

Janssen [25] 1994 Utrecht Netherlands 76 12 PCS IV

Infantino [26] 1995 Padova Italy 21 24 RCS IV

Murthy [27] 1996 Washington DC USA 33 31 RCS IV

van Dam [22,23]† 1996/2000 Rotterdam Netherlands 75 and 89 14 and 52 PCH IIB

Kahn [18] 1997 London UK 231 72 RCS IV

Khubchandani [28] 1997 Allentown, PA USA 123 38 RCS IV

Cundiff [29] 1998 Durham, NC USA 69 12 RCS IV

Tjandra [30] 1999 Melbourne Australia 59 19 RCH IV

Van Laarhoven [31] 1999 London, St Marks UK 22 27 RCS IV

Boccasanta [32] 2001 Milan‡ Italy 267 24 RCS IV

Lopez [33] 2001 Stockholm Sweden 25 61 PCH IV

Ayabaca [34] 2002 Rome Italy 60 48 RCS IV

Ayav [35] 2004 Nancy France 21 58 RCS IV

Heriot [36] 2004 London UK 45 24 RCS IV

Maher [37] 2004 Brisbane Australia 38 12.5 PCS IV

Mercer-Jones [38] 2004 Newcastle UK 22§ 12.5 PCS IV

Nieminen [14] 2004 Tampere Finland 30 12 RCT IIB

Abramov [7] 2005 Evanston, IL USA 307 12 PCH IIB

Dippolito [39] 2005 Bethlehem, PA USA 13 16 RCS IV

Milani [40] 2005 Milan Italy 63 17 PCS IV

Roman [41] 2005 Rouen France 71 74 RCS IV

Thornton [42] 2005 Sydney Australia 82 44 RCH IIB

Altman [43] 2006 Stockholm Sweden 23 36 PCS IV

Paraiso [15] 2006 Cleveland, OH USA 105 24 RCT IB

Yamana [44] 2006 Tokyo Japan 30 38 PCS IV

Gustilo-Ashby [45] 2007 Cleveland, OH USA 99 12 RCT IIB

Lim [46] 2007 Melbourne Australia 53 36 RCS IV

Puigdollers [47] 2007 Barcelona Spain 35 12 PCS IV

Sardeli [48] 2007 Aarhus Denmark 51 27 RCS IV

Tsujinaka [49] 2007 Chiba Japan 111 12 PCH IIB

Biehl [50] 2008 Atlanta, GA USA 195 13.8 RCS IV

Harris [8] 2009 Orlando, FL USA 73 14 RCH IV

Schwandner [51] 2009 Giessen Germany 102 18 RCS IV

Leal [52] 2010 Teresina Brazil 35 12 PCS IV

Cruz [53] 2011 Brazil Brazil 75 21 PCS IV

Chung [54] 2012 Seoul S Korea 50 12 RCH IIB

Mahmoud [55] 2012 Mansoura Egypt 45 12 PCH IIB

Sung [17] 2012 Providence, RI USA 160 12 PCH IIB

van der Hagen [56] 2012 Stadskanaal Netherlands 27 12 RCS IV

Guzman Rojas [57] 2015 ‡ Australia/Chile 137 16 PCH IIB

Shafik [58] 2015 Cairo Egypt 84 12 PCS IV

Melich [59] 2016 Chicago, IL USA 23 12 PCS IV

N, Number of patients; PCS, Prospective Case Series; PCH, Prospective Cohort Study; RCS, Retrospective Case Series; RCH,

Retrospective Cohort Study; RCT, Randomised Controlled Trial.

*Oxford CEBM [60].

†Same cohort of patients, study from 1996 used for peri-operative data and study from 2000 long term outcome data.

‡Multicentre study.

§Twenty-four patients entered study: two were excluded due to rectal injury and so no mesh implanted.




Harms

Perioperative complicationsFour measures of harm were reported by a majority of

studies within the review: overall complications, bleed-

ing, fistulation and haematoma/sepsis. There was con-

siderable heterogeneity in surgical morbidity, reported

as overall procedural complication rates; with individual

study rates varying from 0% to 61% (see Table 2). This

heterogeneity may have reflected (for example) differ-

ing inclusion, procedural content, context of care, or

thresholds or conventions for recording complications.

Random effects meta-analysis found the overall compli-

cation rate to be 11.5% (95% CI: 7.2–16.6%),I2 = 87% (Fig. 3). Overall complication rates varied

within and between procedures without evidence to

favour one or more procedures. Although variable, the

bleeding complication rate was generally low being

reported as zero in 50% of cohorts of procedures. Ran-

dom effects meta-analysis found the pooled bleed rate

to be 2.0% (95% CI: 0.7–3.6%), I2 = 68%. The

reported fistulation rate was consistently low (0% in

80% of cohorts). Random effects meta-analysis found

the fistulation rate to be 0.0% (95% CI: 0.0–0.1%),I2 = 0%. The rate of haematoma or sepsis varied

between studies but was generally low (0% in 56% of

cohorts). Random effects meta-analysis found the

pooled rate of haematoma or sepsis to be 0.9% (95%

CI: 0.2–2.0%), I2 = 54% (Fig. 4). Although there was

some evidence of variation by procedure, sub-group

findings are based on selective reporting of relatively

few and small studies and should be viewed with cau-

tion.

Other measures of short term harm were less consis-

tently reported: perioperative pain (37% of cohorts),

urine retention (6%) and UTIs (10%).

Long term adverse outcomesMeasures of long term harm were poorly reported:

urgency (19%) and anal stenosis (13%). Although 37

cohorts (60%) made some assessment of dyspareunia,

these assessments were not made in an adequately com-

parable fashion. Wide variations between studies may

reflect inconsistency in the studies when reporting

improvement, deterioration or de novo dyspareunia. Rates

of mesh erosion were as high as 30% but were only

reported in two studies [40,46]. This adverse outcome is

devastating for the female sufferer and is rightly receiving

extensive media coverage, focus by some regulatory bod-

ies (e.g. Scottish Government) and much interest by sur-

geons themselves. It is thus unfortunate that in the

narrowly defined context of this systematic review, evi-

dence regarding this outcome was of poor quality.


• Evidence is drawn from observational studies and

comparisons. Most comparisons featured considerable

heterogeneity, which may have multiple causes (level

IV).

• Overall procedural complication rates ranged from 0%

to 61%. However, these complications typically

occurred in about 7–17% of procedures (level IV).

• Post-operative bleeding rates were low, typically rang-

ing from 0% to 4% (level IV).

• Fistulation was a very rare complication, not occur-

ring at all in most studies (level IV).

• Mesh erosion was a common complication, but only

reported in two studies (level IV).

• The occurrence of haematoma or sepsis was typically

low at around 0–2% (level IV).

• Considering measures of harm, there was insufficient

evidence to prefer one type of procedure over another

(level IV).

• Long term adverse outcomes were poorly reported

(level IV).

• Dyspareunia was reported too inconsistently to make

meaningful comparisons between procedures,

although it may be central to patient decision making

(level IV).

• Only two procedure-related deaths were reported for

3209 patients included in studies (level IV).

Efficacy

Most studies used ad hoc questionnaire assessment of

symptoms (n = 27) to assess efficacy; other tools used

included Cleveland Clinic Constipation score (n = 2),

Wexner constipation score (n = 3), obstructed defaeca-

tion score (n = 4) with single studies using the follow-

ing: PAC QOL; Short Form-36 (SF-36); St Mark’s

Figure 2 Venn diagram showing the distribution of studies

between different types of repair. KEY: Box denotes number of

studies in each category. *includes only one Level IB RCT

[15].




Table

2Perioperativedatabyprocedure.

Author

Year

N

Len

gth

of

procedure*

Len

gth

ofstay

†TotalCx

rate

Bleed

ing

Fistulation

Pain

Haematoma/

Sepsis

Urgen

cy

Anal

sten

osis

Urine

retention

UTI

Dyspareu

nia

(new

)Other

(a)Transvaginalrepa

ir:standard

Arnold

[24]

1990

29

NR

5.6

(3–1

4)

34

00

17

3NR

NR

NR

NR

23

NR

Infantino[26]

1995

8NR

NR

12.5

00

012.5

NR

NR

NR

NR

NR

NR

Kahn[18]

1997

231

NR

NR

NR

NR

NR

22

NR

13

NR

NR

NR

9NR

Cundiff[29]

1998

69

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

�10

NR

Lopez

[33]

2001

25

NR

6.3

(3–1

6)

28

00

020

0NR

4%

4%

13§

NR

Maher

[37]

2004

38

52(10–1

25)

4.3

(3–1

0)

7.9

00

02.6

0NR

NR

2.6%

�32

2.6%inadverten

t

proctotomy

Nieminen

[14]

2004

15

35(20–5

0)

NR

00

00

00

NR

NR

NR

0NR

Abramov[7]

2005

183

NR

NR

5.4

30

NR

0NR

NR

NR

NR

33

NR

Paraiso

[15]

2006

37

150(SD68)

2(1–1

9)

43.2

50

NR

14

NR

NR

NR

11%

01ileu

s

Yam

ana[44]

2006

30

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

7NR

Gustilo-A

shby

[45]

2007

33

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Tsujinaka[49]

2007

40

63.5

(19–1

23)

15(10–2

2)

NR

50

17.5

0NR

NR

NR

NR

NR

NR

Harris[8]

2009

37

85.5

318.9

2.7

00

5.4

NR

NR

NR

NR

12

NR

Schwandner

[51]

2009

102

36.5

(29–6

7)

4.1

(2–7

)11

20

NR

2NR

NR

NR

2%

NR

NR

Chung[54]

2012

24

74

212.5

00

00

0NR

NR

NR

8NR

Sung[17]

2012

81

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Shafik[58]

2015

84

45(35–5

5)

4.2

(3.1–5

.6)

NR

01.2

00

8.3

NR

NR

NR

2.4

6%constipation

(b)Transvaginalrepa

ir:site-specific

Abramov[7]

2005

124

NR

NR

6.4

30

NR

0NR

NR

NR

NR

33

0%

Paraiso

[15]

2006

37

151(69)

2(1–7

)30

00

NR

0NR

NR

NR

NR

0

Gustilo-A

shby

[45]

2007

37

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Sardeli[48]

2007

51

32.5

(15–9

0)

2.1

(1–1

4)

24

12

2NR

4NR

NR

NR

NR

4Urinary

incontinen

ce2%

Guzm

anRojas[57]

2015

137

NR

NR

00

0NR

0NR

NR

NR

NR

15

NR

(c)Transanalrepa

ir:blocksuturedrepa

ir

Arnold

[24]

1990

35

NR

5.6

(3–1

4)

34

00

17

3NR

NR

NR

NR

21

NR

Infantino[26]

1995

13

NR

NR

00

00

0NR

NR

NR

NR

NR

0

Van

Laarhoven

[31]

1999

7NR

NR

14

4.5

NR

NR

NR

NR

NR

NR

NR

NR

NR

Boccasanta

[32]

2001

44

79.6

4.5

1.5

25

5NR

0NR

NR

NR

NR

00

Tsujinaka[49]

2007

71

30.5

(16–9

7)

9(6–1

7)

NR

5.6

011

0NR

NR

NR

NR

0NR

(d)Transanalrepa

ir:stapled

transanalresection

Boccasanta

[32]

2001

15

79.6

4.5

1.5

00

00

NR

7NR

NR

0NR

Ayav[35]

2004

21

NA

3.3

(2–5

)0

00

00

00

NR

NR

�4.7

NR




Table

2(C

ontinued

).

Author

Year

N

Len

gth

of

procedure*

Len

gth

ofstay

†TotalCx

rate

Bleed

ing

Fistulation

Pain

Haematoma/

Sepsis

Urgen

cy

Anal

sten

osis

Urine

retention

UTI

Dyspareu

nia

(new

)Other

Harris[8]

2009

36

52.7

2.6

61

19

02.7

0NR

NR

NR

NR

10.5

NR

Leal[52]

2010

35

45(33–7

0)

114

23

00

08.5

8.5

NR

NR

NR

NR

Cruz[53]

2011

75

42

113

17

04

0NR

9.3

NR

NR

NR

NR

Mahmoud[55]

2012

22

20(sd5)

2.0

(0.8)

NR

NR

NR

NR

NR

NR

NR

NR

NR

�58

4.4%overall

denovoFI

(e)Transanalrepa

ir:Delorme’sor

Sarle’sStyle

Janssen

[25]

1994

76

NR

NR

2.6

1.3

01.3

0NR

0NR

NR

NR

Murthy[27]

1996

33

NR

3.7

(1–8

)21

NR

3NR

NR

NR

NR

18

NR

NR

NR

Khubchandani[28]

1997

123

NR

NR

NR

NR

1NR

NR

NR

NR

NR

NR

NR

2.8%flap

retraction

Tjandra

[30]

1999

59

NA

NR

3.4

1.7

0NR

0NR

NR

2NR

NR

NR

Boccasanta

[32]

2001

82

79.6

4.5

1.5

81

NR

NR

NR

2.1

3.5

NR

0NR

Ayabaca[34]

2002

13

NR

NR

30

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Nieminen

[14]

2004

15

35(6)

NR

13

00

00

0NR

NR

NR

70

Dippolito

[39]

2005

13

NR

1.9

30

NR

NR

NR

NR

0NR

NR

NR

NR

Minor

complication

Roman

[41]

2005

71

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Thornton[42]

2005

40

NA

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Puigdollers[47]

2007

11

NA

NR

NR

00

NR

NR

NR

NR

NR

NR

NR

NR

Chung[54]

2012

26

61.5

20

00

00

0NR

NR

NR

00

Mahmoud[55]

2012

23

45(6)

4.0

(1.6)

NR

NR

NR

NR

NR

NR

NR

NR

NR

�58

4.4%de

novoFI

(f)Com

bined

transvaginalandtransanalDelormes/Sarlesstyle

vanDam

[22]

1996

75

NR

NR

NR

NR

4NR

5.30

NR

NR

NR

20

NR

NR

(g)Transperinealrepa

ir

Boccasanta

[32]

2001

126

73.4

5.2

00

0NR

NR

NR

NR

NR

NR

17

1Death

Ayabaca[34]

2002

11

NR

NR

30

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

Puigdollers[47]

2007

24

NR

NR

8.3

00

NR

8.3

NR

NR

NR

NR

NR

NR




Author

Year

N

Len

gth

of

procedure*

Len

gth

of

stay

†Total

Cxrate

Bleed

ing

Fistulation

Pain

Haematoma/

Sepsis

Urgen

cy

Anal

sten

osis

Urine

retention

UTI

Dyspareu

nia

(new

)Other

Repair

type

Mesh

type

(h)Meshrepa

irs

Van Laarhoven

[31]

1999

15

NR

NR

14

4.5

NR

NR

9.1

NR

NR

NR

NR

NR

NR

TP

Syn

thetic

marlex

Mercer-Jones

[38]

2004

24

NR

2(1–6

)14

00

014

0NR

NR

NR

4.5

TP

Syn

thetic

prolene/

Vipro

II

Milani[40]

2005

63

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

18%

19.5%mesh

erosion

TV

Syn

thetic

prolene

Altman

[43]

2006

23

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

VAS‡2

pre

1,6

post

NR

TV

PX

Paraiso

[15]

2006

31

169(62)

2(1–6

)42

30

NR

6NR

NR

NR

19

0NR

TV

PX

Gustilo-

Ashby[45]

2007

29

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

TV

PX

Lim

[46]

2007

53

39

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

26%

19%vaginal

discharge;

30%

mesherosion;

63%atrophic

vaginitis

TV

Syn

thetic

vipro

II

Biehl[50]

2008

95

NR

NR

NR

11

NR

1NR

3–

NR

NR

25

11%incision

deh

iscence

TV

PDX

Biehl[50]

2008

100

NR

NR

NR

10

NR

NR

NR

7.4

–NR

NR

36

5.3

incision

deh

iscence

TV

HDA

Sung[17]

201

79

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NR

NA

NA

TV

PSS

vander

Hagen

[56]

2012

27

56(50–6

8)

3(2–6

)7.4

NR

NR

NR

NR

NR

NR

NR

NR

3.70%

7.4%port

site

infection

TV

Syn

thetic

prolene

Melich[59]

2016

23

NR

NR

40

00

4NR

NR

NR

NR

11%

NR

TV

PDX

strattice

Allratesarepercentages

wherenegativevalues

indicatereductionfrom

preoperativestate;

Cx,

complication;NR,Notrecorded

;TV,transvaginal

repair;

TP,transperinealrepair;

PX,

porcinexenograft;PDX,porcinedermal

xenograft;HAD,human

dermal

allograft;PSS,porcinesub-intestinal

submucosa.

*Meanminutes(range).

†Mean(range)

days.

‡Visual

analoguescore

2pre,1.6

post.

§Twen

ty-seven

percentageat

5yearsfollow

up.

¶Vaginal

sten

osis.

Table

2(C

ontinued

).




Table 3 Summary of selected data from Table 2.

Procedure

Procedure duration (min) Length of stay (days) Follow-up (months)

N Mean Range N Mean Range N Mean Range

Standard TVR 8 67.6 (35.0–150.0) 9 5.2 (2.0–15.0) 17 22.9 (8.0–72.0)

Site-specific TVR 2 91.8 (32.5–151.0) 2 2.1 (2.0–2.1) 5 18.2 (12.0–27.0)

Block sutured TAR 2 55.1 (30.5–79.6) 3 6.4 (4.5–9.0) 5 22.2 (12.0–27.0)

Delormes/Sarles TAR 3 62.0 (45.0–79.6) 5 3.2 (1.9–4.5) 13 27.2 (12.0–74.0)

Delormes/Sarles TAR + TVR 0 – – – – (0.0–0.0) 1 52.0 –

Stapled transanal resection 5 47.9 (20.0–79.6) 6 2.4 (1.0–4.5) 6 20.4 (8.0–58.0)

Transperineal repair 1 73.4 – 1 5.2 – 3 28.0 (12.0–48.0)

Mesh repair 3 88.0 (39.0–169.0) 3 2.3 (2.0–3.0) 12 19.0 (12.0–36.0)

All procedures 24 66.6 (20.0–169.0) 29 3.9 (1.0–15.0) 62 23.1 (8.0–74.0)

Figure 3 Forest plot showing rates oftotal procedural complications

(percentage of patients) by procedure

type. KEY: TVR, transvaginal repair;TAR, transanal repair; TV, transvaginal;TP, transperineal.




incontinence score; Pelvic Floor Distress Inventory-20

(PFDI-20) questionnaire; Pelvic Floor Impact-7 (PFI-

7) questionnaire; Pelvic Organ Prolapse/Urinary Incon-

tinence Sexual Questionnaire (PISQ-12). Global ‘suc-

cess’ or ‘satisfaction’ ratings (GSR) were obtained via a

variety of methods for 47 of the 62 cohorts (where ‘sat-

isfied’ or ‘very satisfied’, ‘good’, ‘very good’ and ‘excel-

lent’ were interpreted as positive outcomes) (Table 4).

Further, some studies also reported individual symp-

toms. No study reported acquiring data objectively

using personnel not involved in the surgical care of the

patient or data collection blind to intervention status

(RCTs were not observer-blinded).

Data were too inconsistently reported to usefully

analyse efficacy outcomes either in their natural units or

after standardisation. Instead a binary response of global

improvement (yes/no) was derived for each cohort of

patients. Reported in 76% of procedures, random effects

meta-analysis found global improvement to be 72.8%

(95% CI: 66.8–78.3%), I2 = 86% (Fig. 5); again there

was considerable heterogeneity between findings. Given

the crudeness and imprecision of estimates, as well as

small numbers of studies/patients for some procedures,

there is insufficient evidence that particular procedures

provide higher levels of improvement.

For individual symptoms, changes in percentage of

patients experiencing each symptom were not reported

for a majority of studies. Straining was reported for

45% of total procedures; incomplete emptying for 47%;

vaginal digitation for 50%. Other symptoms were less

frequently reported. All symptom measures featured

considerable heterogeneity and selective reporting by

(generally) small studies limiting any comparison

between procedures. These caveats accepted, the overall

Figure 4 Forest plot showing rates ofhaematoma or sepsis (percentage of

patients) by procedure type. KEY: TVR,

transvaginal repair; TAR, transanal repair;

TV, transvaginal; TP, transperineal.




Table 4 Percentage success based on global satisfaction ratings and individual recorded symptoms.

Authors Year N FU

Global %

improved

% Reduction in symptom

Straining

Incomplete

empty

Vaginal

digitation

Anal

digitation

Perineal

digitation

(a) Transvaginal repairs (including site specific repair)

Transvaginal

Arnold [24] 1990 29 24 77 NR NR NR NR NR

Infantino [26] 1995 8 36 75 88 75 75 NR NR

Kahn [18] 1997 231 72 NR �11 �11 67 77 77

Cundiff [29] 1998 69 12 * 30 NR NR NR NR

Lopez [33] 2001 25 61 NR NR 91 48 NR NR

Maher [37] 2004 38 12.5 97 60 NR 84 NR 84

Nieminen [14] 2004 15 12 93 NR NR 66 66 66

Abramov [7] 2005 183 12 NR 18 NR NR NR NR

Paraiso [15] 2006 37 24 74 32 17 24 NR 24

Yamana [44] 2006 30 38 90 90 60 42 NR NR

Gustilo-Ashby [45] 2007 33 12 48 31 28 34 NR 34

Tsujinaka [49] 2007 40 12 80 NR NR 35 NR 35

Harris [8] 2009 37 8 78 † NR NR NR NR

Schwandner [51] 2009 102 18 70 NR 83 67 NR 67

Chung [54] 2012 24 12 75 NR NR NR NR NR

Sung [17] 2012 81 12 NR 9 30 18 NR 18

Shafik [58] 2015 84 12 94 NR NR NR NR NR

Site specific

Abramov [7] 2005 124 12 NR 20 NR NR NR NR

Paraiso [15] 2006 37 24 88 35 18 37 NR 37

Gustilo-Ashby [45] 2007 37 12 50 31 28 34 NR 34

Sardeli [48] 2007 51 27 NR NR 14 NR NR NR

Guzman Rojas [57] 2015 137 16 85 36 NR NR NR NR

(b) Transanal repairs

Block sutured

Arnold [24] 1990 35 NR 83 80 NR NR NR NR

Infantino [26] 1995 13 24 85 92 77 86 NR NR

Van Laarhoven [31] 1999 7 27 43 NR 0 17 NR NR

Boccasanta [32] 2001 44 24 42 NR NR NR NR NR

Tsujinaka [49] 2007 71 12 83 NR NR 34 NR 34

Stapled

Boccasanta [32] 2001 15 11.3 42 NR NR NR NR NR

Ayav [35] 2004 21 58 76 NR 76 67 NR NR

Harris [8] 2009 36 8 83 † NR NR

Leal [52] 2010 35 12 88 ‡ NR NR NR NR

Cruz [53] 2011 75 21 NR NR NR NR NR NR

Mahmoud [55] 2012 22 12 78 51 45 45 NR NR

Delorme’s style

Janssen [25] 1994 76 12 84 56 41 21 NA NA

Murthy [27] 1996 33 31 62 19 19 NR NR NR

Khubchandani [28] 1997 123 38 82 NR NR NR NR NR

Tjandra [30] 1999 59 19 NR NR 78 39 39 NR


Ayabaca [34] 2002 13 48 69 68 NR NR NR NR

Nieminen [14] 2004 15 12 73 NR NR 39 39 39

Dippolito [39] 2005 13 16 92 NR 86 NR NR NR




pooled finding for reduction in strain was 38.0% (95%

CI: 27.1–49.6%), I2 = 94%; reduction in incomplete

emptying was 44.4% (95% CI: 30.2–58.9%), I2 = 96%;

and reduction in vaginal digitation was 42.7% (95% CI:

34.9–50.6%), I2 = 86%.

The aim of reinforcing the rectovaginal septum is

to restore normal anatomy which theoretically will

enable normal evacuation. Given the underlying aim of

surgery is to correct anatomy, an assessment of

anatomical recurrence is also important (although this

is necessarily only a surrogate of clinical outcome).

Studies variously and inconsistently reported clinical,

radiological and symptom recurrence (Table 5). Clini-

cal recurrence was reported for 44% of cohorts

(Fig. 6). The overall clinical recurrence rate was 17.1%

(95% CI: 11.7–23.3%), I2 = 89%, with individual

findings for procedures varying from 0% to 55%. There

is a suggestion that site specific TVR features a higher

clinical recurrence rate that other procedures, based on

four studies and 349 patients, although this may be a

chance finding given the selective reporting by studies

(Fig. 6). One study showed that the results of a site

specific repair are further compromised by the concur-

rent use of collagen mesh [15].


• Data on efficacy were inconsistently measured and



• Although inconsistent, assessments of patient global

improvement typically suggest a good outcome in

about 67–78% of patients (level IV).


Authors Year N FU

Global %

improved

% Reduction in symptom

Straining

Incomplete

empty

Vaginal

digitation

Anal

digitation

Perineal

digitation

Roman [41] 2005 71 74 29.6 NA 50.7 42.30 42.3 NA

Thornton [42] 2005 40 44 28 NR NR NR NR NR

Puigdollers [47] 2007 11 12 66 52 74 52 NR 52

Chung [54] 2012 26 12 77 NR NR NR NR NR

Mahmoud [55] 2012 23 12 78 51 45 45 NR NR

Combined TV and TA

van Dam [22] 2000 89 52 69 NR NR NR NR NR

(c) Transperineal repairs


Ayabaca [34] 2002 11 48 73 NR NR NR NR NR

Puigdollers [47] 2007 24 12 66 52 74 52 NR 52

(d) Mesh repairs

Mesh

Van Laarhoven [31] 1999 15 27 87 NA 67 47 NA NA

Mercer-Jones [38] 2004 22 12.5 55 30 50 23 NA NA

Milani [40] 2005 63 17 NA NA NA NA NA NA

Altman [43] 2006 23 36 NA 16 6 15 �6 NA

Paraiso [15] 2006 31 24 90 27 65 44 NA 44

Gustilo-Ashby [45] 2007 29 12 76 31 28 34 NA 34

Lim [46] 2007 53 36 47 31 NA NA NA NA

Biehl [50] 2008 95 13.8 NA NA NA NA NA NA

Biehl [50] 2008 100 13.8 NA NA NA NA NA NA

Sung [17] 2012 79 12 NA 9.2 30 18 NA 18

van der Hagen [56] 2012 27 12 NA NA NA NA NA NA

Melich [59] 2016 23 12 NA NA NA NA NA NA

Negative values indicate increase in symptoms.

*Global improvement over all studied = 8.6 (scale from 0 to 10).

†ODS score Post 1.86 (no data pre).

‡Cleveland Clinic Constipation score Pre 15.2 vs Post 4.4 (P = 0.001).




• Findings for global improvement, derived from global

satisfaction rating scales, provide insufficient evidence

to prefer one type of procedure over another (level

IV).

• Other patient symptom scores were inconsistently

reported (level IV).

• Approximately 30–50% of patients may experience

reduced symptoms of straining, incomplete empty-

ing or reduced vaginal digitation (level IV).

• Anatomical recurrence (as judged by a variety of mea-

sures) occurred in approximately 17% patients at

mean follow up of 23.4 months (range 12–74) (level

IV).

Patient selection

Patient selection is generally perceived by experts as impor-

tant when choosing a surgical approach. There was a vast

variation in the preoperative investigation of patients in the

studies. Most studies included evacuation imaging (33 out

of the total 43) where defaecation proctography was used

in all but one (which used isotope imaging) [36]. There

was selective use of anal ultrasound, anorectal physiological

assessment, with colonic transit studies being recorded in

12 studies. There was however little correlation between

the results of surgery and preoperative investigation results.

Key features include the presence of a symptomatic

Figure 5 Forest plot showing rates ofglobal rating of satisfaction (percentage

of patients) by procedure type. KEY:

TVR, transvaginal repair; TAR, transanalrepair; TV, transvaginal; TP,

transperineal.




Table 5 Recurrence rates by type of operation

Authors Year N FU

Recurrence rate %

Clinical Radiological Symptoms

(a) Vaginal repairs

Transvaginal

Arnold [24] 1990 29 NR NR NR NR

Infantino [26] 1995 8 36 13 NR NR

Kahn [18] 1997 231 72 11 NR NR

Cundiff [29] 1998 69 12 NR NR NR

Lopez [33] 2001 25 61 NR NR NR

Maher [37] 2004 38 12.5 NR NR NR

Nieminen [14] 2004 15 12 7 7 7

Abramov [7] 2005 183 12 18 NR 4

Paraiso [15] 2006 37 24 25 NR NR

Yamana [44] 2006 30 38 0 3.3 0

Gustilo-Ashby [45] 2007 33 12 NR NR NR

Tsujinaka [49] 2007 40 12 NR NR NR

Harris [8] 2009 37 8 11 NR NR

Schwandner [51] 2009 102 18 NR NR 53

Chung [54] 2012 24 12 NR NR NR

Sung [17] 2012 81 12 39 NR 35

Shafik [58] 2015 84 12 NR NR 6

Site specific

Abramov [7] 2005 124 12 44 NR 11

Paraiso [15] 2006 37 24 40 NR NR

Gustilo-Ashby [45] 2007 37 12 NR NR NR

Sardeli [48] 2007 51 27 41 NR NR

Guzman Rojas [57] 2015 137 16 25 20 34

(b) Transanal repairs

Block suture

Arnold [24] 1990 35 NR NR NR NR

Infantino [26] 1995 13 24 7.6 NR NR

Van Laarhoven [31] 1999 7 27 NR NR NR

Boccasanta [32] 2001 44 24 13 NR 5.9

Tsujinaka [49] 2007 71 12 NR NR NR

Stapled

Boccasanta [32] 2001 15 11.3 13 NR 5.9

Ayav [35] 2004 21 58 NR 57 NR

Harris [8] 2009 36 8 2.7 NR NR

Leal [52] 2010 35 12 NR NR NR

Cruz [53] 2011 75 21 NR 11 NR

Mahmoud [55] 2012 22 12 NR NR NR

Delorme’s style

Janssen [25] 1994 76 12 84 56 41

Murthy [27] 1996 33 31 NR NR NR

Khubchandani [28] 1997 123 38 8.9 NR 8.9

Tjandra [30] 1999 59 19 NR NR 1.7

Boccasanta [32] 2001 82 24 13 NR 5.9

Ayabaca [34] 2002 13 48 NR NR NR

Nieminen [14] 2004 15 12 40 40 33

Dippolito [39] 2005 13 16 92 NR 86

Roman [41] 2005 71 74 29.6 NA 50.7




rectocoele greater than 2 cm on proctography with evi-

dence of contrast trapping at the end of maximal evacua-

tion. Where graded, generally rectocoeles operated upon

were grade 2 or 3. Only one study measured the rectocoele

clinically with POPQ assessment [37]. Other than medical

co-morbidity precluding surgery there were very few con-

sistent exclusion criteria in any of the studies, although sev-

eral excluded those women with slow transit constipation.

Furthermore, in the few studies that related preoperative

assessment to outcome, none could show an association

between baseline symptoms or size of rectocoele and func-

tional outcome. The need to digitate to assist evacuation

did not appear to predict outcome following surgery, but

may predict the need to digitate postoperatively.


• Although patient selection is perceived as vital in pre-

dicting outcome it was inconsistently documented

(level IV).

• There was no evidence to support better outcomes

based on selection of patients with a particular size or

grade of rectocoele (level IV).

Conclusions


and long terms benefits and harms of recto-vaginal rein-

forcement procedures to treat symptoms of constipation

identified only one high quality study. Two further ran-

domized controlled trials were identified although these

were small and had methodological limitations. The evi-

dence base was therefore characterised almost exclu-

sively by observational studies of variable and often

uncertain methodological quality. Future studies should

provide robust and comparative evidence for clinicians

to support patient decision making, both in terms of

the incremental benefits and harms of procedures.


Authors Year N FU

Recurrence rate %

Clinical Radiological Symptoms

Thornton [42] 2005 40 44 NR NR 56

Puigdollers [47] 2007 11 12 NR NR NR

Chung [54] 2012 26 12 NR NR NR

Mahmoud [55] 2012 23 12 NR NR NR

Combined TV and TA

van Dam [22] 2000 89 52 NR NR 29

(c) Transperineal repairs

Boccasanta [32] 2001 50 24 13 11 6.40

Ayabaca [34] 2002 11 48 NR NR NR

Puigdollers [47] 2007 24 12 NR NR NR

Authors Year N FU

Recurrence rate %

Repair type Mesh typeClinical Radiological Symptoms

(d) Mesh repair

Van Laarhoven [31] 1999 15 27 NA NA NA TP/TA Synthetic marlex

Mercer-Jones [38] 2004 24 12.5 4.50 NA NA TP Synthetic prolene/Vipro II

Milani [40] 2005 63 17 NA NA NA TV Synthetic prolene

Altman [43] 2006 23 36 NA NA NA TV Porcine xenograft

Paraiso [15] 2006 31 24 55 NA NA Site specific Porcine xenograft

Gustilo-Ashby [45] 2007 29 12 NA NA NA TV Porcine xenograft

Lim [46] 2007 53 36 22 NA NA TV Synthetic vipro II

Biehl [50] 2008 95 13.8 1 NA NA Site specific Porcine dermal xenograft

Biehl [50] 2008 100 13.8 7 NA 3 Site specific Human dermal allograft

Sung [17] 2012 79 12 38.9 NA 34.8 TV Porcine subintestinal submucosa

van der Hagen [56] 2012 27 12 NA NA NA TV Synthetic prolene

Melich [59] 2016 23 12 4 4 4 TV Porcine dermal xenograft strattice




Greater understanding is required of the mediating

effects of prognostic factors particularly preoperative

definition of both functional and radiological parame-

ters that impact upon treatment success.

Acknowledgements






















Figure 6 Forest plot showing rates of clinical recurrence (percentage of patients) by procedure type. KEY: TVR, transvaginal repair;TAR, transanal repair; TV, transvaginal; TP, transperineal.







NHS Foundation Trust; Mr Neil Smart, Royal Devon &

Exeter NHS Foundation Trust; Ms Natasha Stevens,


Douglas Tincello, University Hospitals of Leicester NHS

Trust; Miss Karen Telford, South Manchester NHS

Foundation Trust; Mr Paul Vollebregt, Queen Mary

University of London; Mr Andrew Williams, Guy’s and

Thomas’ NHS Foundation Trust; Professor Yan Yian-

nakou, County Durham and Darlington NHS Founda-

tion Trust.



Funding







ment of Health.

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Results V: Sacral Nerve Stimulation

S. A. Pilkington*, C. Emmett†, C. H. Knowles‡, J. Mason§, Y. Yiannakou†, On behalf of the

NIHR CapaCiTY working group¶ and Pelvic floor Society**

*University Hospital Southampton, Southampton, UK, †County Durham and Darlington NHS Foundation Trust, Durham, UK, ‡National Bowel

Research Centre, Blizard Institute, Queen Mary University London, London, UK, §Warwick Medical School, University of Warwick, Coventry, UK,

¶National Institute for Health Research: Chronic Constipation Treatment Pathway, London, UK, and **Affiliate section of the Association of

Coloproctology GB and Ireland, London, UK

Abstract

Aim To assess the outcomes of sacral nerve stimulation

in adults with chronic constipation.







Results Seven articles were identified, providing data on

outcomes in 375 patients. Length of procedures and

length of stay was not reported. Data on harms were

inconsistently reported and heterogeneous, making esti-

mates of harm tentative and imprecise. Morbidity rates

ranged between 13 and 34%, with overall device

removal rate between 8 and 23%. Although inconsis-

tently reported, pooled treatment success was typically

57–87% for patients receiving permanent implants,

although there was significant variation between studies.

Patient selection was inconsistently documented. No

conclusions could be drawn regarding particular pheno-

types that responded favourably or unfavourably to

sacral nerve stimulation.

Conclusion Evidence supporting sacral nerve stimula-

tion is derived from poor quality studies. Three

methodologically robust trials are have reported since

this review and all have all urged greater caution.

Keywords Constipation, sacral nerve stimulation, neu-

romodulation, slow transit constipation

Introduction


Sacral nerve stimulation (SNS) is well established for pelvic

urinary indications and for the treatment of faecal inconti-

nence when conservative measures have failed [1,2]. Its

role in the management of chronic constipation (CC) has

been studied since 2001 [3], based on a century of experi-

mental (multiple species: physiological and anatomical)

and clinical data that the sacral innervation has a prokinetic

effect on the rectum and colon via ascending colonic

nerves [4]. Brindley stimulation has exploited this effect in

small numbers of patients since the 1980s [5,6] andmech-

anistic studies from Adelaide of SNS effects on transit and

colonic contractile activity have confirmed potential to

increase anterograde contractile activity, reduce retro-

grade activity and speed transit [7]. SNS in its current

form uses chronic low amplitude stimulation of a chosen

sacral nerve root (usually S3) via a percutaneously placed

quadripolar electrode and implanted pulse generator.

There are procedural variations in terms of testing phase

(temporary wire ‘basic’ vs tined lead ‘advanced’ evalua-

tion) however the final assembly of components is uniform

reflecting a single current manufacturer (Medtronic Inc

Medtronic Limited, Watford, Herts, UK) for this clinical

indication.

Scope

The purpose of this study was to assess the efficacy and

harms of implanted SNS for adult patients whose main

presenting complaint is chronic constipation. Proce-

dures beyond the scope of this review include other

forms of neurostimulation (e.g. transcutaneous, vaginal,

Correspondence to: Miss Sophie Pilkington, Mailpoint 134, University Hospital

Southampton, Tremona Road, Southampton, SO16 6YD, UK.








transanal, pudendal) and temporary SNS (i.e. where

data are only available during the testing phase).

Previous reviews

Two systematic Cochrane reviews have focused on

SNS for constipation, although faecal incontinence

was also included. The first (2007 [8]) concluded

that SNS can reduce symptoms in selected patients

with constipation, however this was based on a single

study which included two patients [9]. The second

included two RCTs and concluded that SNS did not

improve symptoms in patients with constipation,

although it recognised that the evidence was severely

limited [10].


The search yielded a total of 20 citations for full text

review from a total of 121 abstracts found by initial

search criteria (Fig. 1: PRISMA diagram). From these,

only seven articles published between 2001 and 2015

contributed to the systematic review, providing data on

outcomes in a total of 375 patients (range 21–117patients per study) (Table 1. Specific exclusions after

full-text review (and after exclusion of non-English lan-

guage publications: n = 1) [11] included nine studies

where the population sample was confirmed to be less

than 20 patients [3,12–19], one study [20] which was a

dual publication reporting a patient cohort that over-

lapped with another study [21] and one study where

results were combined for mixed indication s [22].

Study follow up ranged from 20 to 51 months.


quate description of methods. The seven included stud-

ies were all observational and all provided uncontrolled

LEVEL IV evidence, including one low quality prospec-

tive cohort study, two prospective and four retrospec-

tive case series. Mean patient follow up ranged from 20

to 51 months (median 27 months). All studies derived

from European centres, with three from UK and one

each from Spain, The Netherlands, Italy and Sweden.

Perioperative data

There were few data concerning standard perioperative

variables. All studies failed to include data on duration

of procedure, number of cases performed as day surgery

or duration of inpatient stay. A summary of periopera-

tive data is provided in Table 2. Peculiar to SNS, data

were reported on paradigm of test stimulation i.e. there

is more than one way to perform test stimulation. The

use of a previously described ‘standard procedure’ is sta-

ted in the methods section in only three studies [23–25]. The duration of temporary SNS was reported as

2 weeks in two of the studies [25,26] and 3 weeks in

five of the studies [21,23,24,27,28]. The use of antibi-

otics during permanent SNS placement was reported by

one study only [23]. Type of anaesthesia for insertion

of temporary and permanent leads was reported in two

studies [20,27,28] and insertion of temporary wires in

the outpatient setting was described in one study [24].




S. A. Pilkington et al. Surgery for constipation

Most studies used a tined quadripolar lead for perma-

nent stimulation. Five studies used a single lead

[21,23,24,28] whilst one study used bilateral stimula-

tion [27] and another used either single or bilateral

[25]. Some additional data pertaining to the cohort of

patients in the Govaert [21] study were reported in an

earlier study by Maeda et al. [20].

Summary evidence statements: perioperative data1 Standard perioperative data (duration of procedure

and length of stay) were not reported by any study

(Level IV)

2 Where reported, general anaesthesia was used for

SNS procedures (Level IV)

3 The number of temporary unipolar SNS leads used

varied (1 or 2) between studies (Level IV)

4 Most studies used a single tined quadripolar lead for

permanent stimulation (Level IV)

Harms

Surgical morbidity, reported as overall procedural com-

plication rates, vary considerably with individual study

rates varying from zero to 39% [24] (Table 3). This

heterogeneity may have reflected (for example) differing

inclusion, procedural content, context of care, or

thresholds or conventions for recording complications.

Random effects meta-analysis found the overall compli-

cation rate to be 22.7% (95% CI: 12.9% to 34.1%),

I2 = 47% (Fig. 2). Device removal was similarly hetero-

geneous: the overall device removal rate was 14.4%

(95% CI: 7.8% to 22.5%), I2 = 47% (Fig. 3). There

were 51 re-operations: 30 for device removal although

five were replaced after resolution of pain or infection,

11 to move or replace the implant, 10 lead problems.

In addition six operations were carried out for treat-

ment of chronic constipation including three subtotal

colectomies [23,28], two stomas and one appendicos-

tomy [28]. Infection resulting in device removal was

reported in three patients. The commonest reason for

explantation was lack of effect and this was reported in

19 cases (Table 3). Two explantations were carried out

for pain associated with the implant and one for lead

migration. There appeared to be no relationship

between device explantation rate and length of follow

up (Table 1).

Patients with SNS for constipation had high levels of

reportable adverse events. Often this was resolved by

reprogramming but more than one-third required surgi-

cal intervention or discontinued therapy. Such data were

specifically reported in the sub-cohort of Govaert et al.

[21], reported separately by Maeda et al. [20] who car-

ried out a retrospective review of 38 patients who had

SNS for constipation and found that 22 patients (58%)

experienced at least one reportable event. The most

common event was lack or loss of efficacy. In 19 events

(33%), surgical intervention was required and the most

common intervention was electrode replacement (14

events). Three adverse events lead to discontinuation of

SNS. The remaining 35 patients were still using SNS

but with a variable degree of benefit.

Summary evidence statements: harms1 Data on harms were inconsistently reported and

heterogeneous (Level IV).

2 The overall procedural complication rate resulting in

reoperation was typically 13–34% (Level IV).

3 Common complications resulting in reoperation

included lack of efficacy, infection, lead problems,

pain at site of implant, unwanted effects relating to

stimulation such as pain (Level IV).

4 Infection rates varied from 0 to 7% (Level IV).

5 Overall device removal rate was typically 8–23% at

mean follow up of 31 months (Level IV)


Author Year Centre Country

Total

N

Implanted

N FU*

Number at final

follow up N (%)‡ Design Level†

Kamm [23] 2010 St Marks UK 62 45 28 38 (61) PCH IV

Sharma [26] 2011 Hull UK 21 11 34 10 (48) RCS IV

Ortiz [24] 2012 Navarra Spain 48 23 26 14 (29) RCS IV

Govaert [21] 2012 Maastricht Netherlands 117 68 37 61 (52) RCS IV

Khan [27] 2014 Durham UK 22 12 20 12 (55) PCS IV

Ratto [25] 2014 Rome Italy 61 42 51 32 (76) RCS IV

Graf [28] 2015 Uppsala Sweden 44 15 24 11 (25) PCS IV


†Oxford 2009 CEBM.

‡Based on intent to treat RCT, Randomised controlled trial; PCH, prospective cohort study; RCS, retrospective case series; PCS,

prospective case series; NR, Not recorded.



Surgery for constipation S. A. Pilkington et al.

Efficacy

Reported clinical outcomes varied in assessment tools

used across the seven studies (Table 4). Most com-

monly, these consisted of validated summative symptom

scores or questionnaires. These included the Cleveland

Clinic Constipation score [23,25], the SF-36 question-

naire [23,25], the Wexner Score [21,24], and PAC-

SYM and PAC-QOL questionnaire [27]. Additionally,

patient bowel diaries were used by several studies, either

as the principal outcome measure [26] or alongside

other measures [21,24,28]. The definition of treatment

success varied between studies. Of the two studies using

the Wexner score, one [24] defined success as a 30%

improvement in this score. The other [21] defined this

as a statistically significant reduction in score from base-

line. Kamm et al. [23] defined success as either ≥ 3

bowel motions per week or ≥ 50% improvement in

straining or ≥ 50% improvement in incomplete evacua-

tion. Other definitions of sustained treatment success

included a statistically significant reduction in Cleveland

Clinic Score and SF-36 from baseline [25], patient

reported clinical improvement [27,28] and 50%

improvement in bowel function (recorded on bowel

diaries [26]). The percentage of initial study recruits

providing data at final follow up varied between studies,

from 25 to 76% (Table 1) denoting significant attrition

in prospective studies.

Accepting variation in definitions used, random effects

meta-analysis found the overall SNS response rate (i.e. to

those beginning treatment but not necessarily implanted)

to be 56.9% (95% CI: 46.8% to 66.7%), I2 = 71%. Long

term overall treatment success was 40.1% (95% CI:

26.3% to 54.7%), I2 = 87%, considering permanently

implanted patients only, treatment success was 73.2%

(95% CI: 57.5% to 86.6%), I2 = 80% (Fig. 4).

Overall, success seemed to be dichotomised with four

studies [21,23,25,26] demonstrating higher success

rates, both in the short and long term, than others. The

largest of these, by Govaert et al. [21], is a retrospective

study at two centres in The Netherlands and Denmark,

with follow up at 1, 3, 6 and 12 months (although this is

difficult to verify for a retrospective study). It appears that

data were collected during routine clinical follow up

rather than as part of a planned research study. There was

considerable drop-out with Wexner scores available for

only 32 (47% of implanted cases) at 6 months. A multi-

centre prospective cohort study [23] demonstrated the

highest positive response rate to temporary SNS, as well

as a high long term success rate (87% of patients with per-

manent implants); the primary outcome was an improve-

ment in one of three domains; bowel frequency, straining

and incomplete evacuation, assessed using questionnairesTable

2Perioperativedatabyprocedure.

Author

Total

N

Implanted

N

Duration

temporary

SNS

(weeks)

Tem

porary

SNS

under

GA

Permanen

t

SNSunder

GA

Typeof

temporary

SNSlead

Number

of

temporary

SNSleadsused

Number

of

Permanen

t

SNSleadsused

Permanen

t

SNSusing

tined

quadripolarlead

Antibioticcover

duringpermanen

tSNS

Kam

m[23]

62

45

3NR

NR

U1

1Y

Y

Sharma[26]

21

11

2NR

NR

NR

NR

NR

NR

NR

Ortiz

[24]

48

23

30

NR

14U:34Q

11

YNR

Govaert[21]

117

68

3NR

NR

U1

1Y

NR

Khan

[27]

22

12

3Y

YU

22

YNR

Ratto

[25]

61

42

2NR

NR

U1OR

21OR

2NR

NR

Graf[28]

44

15

3Y

YU

≥2

1Y

NR

NR,notreported

;U,unipolarlead;Q,quadripolarlead;UT,untined

lead;T,tined

lead;Y,yes.




and validated symptom scores. However, treatment suc-

cess was assessed on last follow up and there was a high

drop-out rate (38% drop-out at 24 months). A further

retrospective study [26] of 21 patients in a single centre

demonstrated a 47% success rate based on patient

reported outcomes and laxative use. Ratto et al. [25]

used a retrospective study design to evaluate outcome

based on validated questionnaires. Although 32/42

(76%) of patients still had implant at the end of follow up

(and therefore considered to be responders to some

degree), only 15 (35%) had a 50% reduction of Cleveland

Clinic Score. Three studies [24,27,28] demonstrated rel-

atively poor efficacy of treatment (Table 4). Two of these

are retrospective case series while the other [27] studied

neurological constipation only.

Summary evidence statements: efficacy1 Data on efficacy were inconsistently measured with

high drop-out rates and heterogeneous findings,

making estimates tentative and imprecise [level IV]

2 Pooled treatment success was typically 57–87% for

patients receiving permanent implants, although

there was significant variation between studies [level

IV]

Patient selection

Patient selection was inconsistent between the seven

studies. There was no unifying criteria for establishing

a diagnosis of chronic constipation (Table 5). Four

studies excluded patients with neurological disease and

one study only included patients with neurological

disease. The proportion of participants with slow tran-

sit constipation (STC) was recorded in six of the

studies. There was no significant difference in

response to SNS when studies were grouped by those

with less or more than 50% of patients with STC

(Fig. 5). Defaecating proctograms were performed in

six of the studies but only used to stratify patients in

two studies (Table 5).

Figure 2 Forest plot showing rates of total procedural compli-

cations (percentage of patients).

Figure 3 Forest plot showing rates of device explantation rate

(percentage of patients).

Table 3 Harms.

Author

Total

N

Implanted

N

Total complications

resulting in

reoperation

Total adverse

events

Infection

resulting in

device removal

Explantation

(permanent

device removal)

Additional

surgery

Kamm [23] 62 45 11/45 (24%) 101 2/45 (4%) 2/45 (4%)

(7/45 exit study)

Subtotal colectomy

1

Sharma [26] 21 11 3/11 (27%) NR 0 0 NR

Ortiz [24] 48 23 9/23 (39%) NR 1/23 (4%) 6/23 (27%) NR

Govaert [21] 117 68 9/68 (13%) NR 3/68 (4.4%) 9/68 (13%) NR

Khan [27] 22 12 0 1 0 0 NR

Ratto [25] 61 42 14/42 (33%) 9 0 8/42 (19%) NR

Graf [28] 44 15 5/15 (33%) 12 PNE

5 PERM

1/15 (7%) 4/15 (27%) Stoma 2

Colectomy 2

Appendicostomy 1

NR, not reported.




Summary evidence statements: patient selection1 All studies included variable phenotypes of chronic

constipation making populations heterogeneous

(Level IV).

2 No conclusions could be drawn regarding particular

phenotypes that responded favourably or unfavour-

ably to SNS (Level IV).

Discussion

The possibility of a minimally invasive technique is a

very attractive option for the management of patients

with chronic constipation, especially as alternative

options may involve potentially hazardous major surgery

with colectomy and uncertain outcome. This systematic

review has identified a number of published series that

might suggest benefit of this treatment, with a pooled

‘success rate’ of 73% of those patients undergoing per-

manent implantation and a device removal rate of

around 12%. These findings would certainly merit fur-

ther study but must be treated with caution as the

majority of the studies were retrospective case series.

There was evidence of considerable loss to follow up,

irregular and imprecise measurement of outcomes, and

ill-defined post-hoc analysis of the data. The outcomes

were, for the most part, reported to the clinicians pro-

viding the treatment and there is a well-recognised

reporting bias here. In addition there may be a strong

publication bias [29].

Several important studies were not included in the

review but merit consideration in the discussion. A ran-

domised, double-blind, placebo-controlled, two-phase

crossover study by Dinning et al. [30] comparing sham,

subsensory and suprasensory stimulation in patients

with STC was excluded from the review due to inade-

quate follow up period (< 12 months). The primary

outcome measure was the proportion of patients who,

on more than 2 days per week for at least 2 of 3 weeks,

Figure 4 Forest plot showing rates of implant long-term suc-

cess rate (percentage of patients).

Table

4Clinical

outcomes

ofSNS.

Author

Year

Total

N

Implanted

NOutcomemeasure

used

Definitionoflong-term

success

Med

ianFU

(Months)

Response

toPNS

N(%

)

Longterm

success(T

otal)

N(%

)

Longterm

success

(Implanted)

N(%

)

Kam

m[23]

2010

62

45

ClevelandClinic

ConstipationScore,

Visual

AnalogueScale,SF-36

Oneof:≥3bowel

movemen

tsper

week;

>+50%

improvemen

tin

strainingand/or

incomplete

evacuation

28

45(73)

39(63)

39(87)

Sharma[26]

2011

21

11

Bowel

functionrecorded

inpatient

diaries.Use

oflaxatives

50%im

provemen

tin

Bowel

function

34

12(57)

10(47)

10(90)

Ortiz

[24]

2012

48

23

Wexner

score,bowel

diaries

30%im

provemen

tin

Wexner

score

26

23(48)

14(29)

14(61)

Govaert[21]

2012

117

68

Wexner

score,bowel

diaries

Retained

implant

37

68(58)

61(52)

61(90)

Khan

[27]*

2014

22

12

Patientassessmen

tofsymptoms

(Likertscale).PAC-SYM,PAC-Q

OL,EuroQoL

Clinical

assessmen

t20

12(55)

6(27)

6(50)

Ratto

[25]

2015

61

42

ClevelandClinic

ConstipationScore,SF36

Retained

implant

51

42(69)

32(52)

32(76)

Graf[28]

2015

44

15

Bowel

diaries,validated

symptom

questionnaire

Sustained

symptom

relief

(patientreported

)24

15(34)

5(11)

5(33)

*Neu

rological

constipation.

NR,NotRecorded

.




reported a bowel movement associated with a feeling of

complete evacuation. This well-conducted trial showed

no clinical effect of sub- or suprasensory stimulation

over sham in 55 patients undergoing permanent SNS

implantation. The proportion of patients who met the

primary outcome measure did not differ between

suprasensory (30%) and sham (21%) stimulations nor

between subsensory (25%) and sham (25%) stimula-

tions. In addition there was no significant change in

quality of life scores. Long term data from this study

have been reported since the systematic review was

completed noting that 88% of patients in the original

study [30] had undergone device removal at median

follow up 5.7 years [31].

A French group have presented data on 20 patients

undergoing permanent SNS after a successful 3-week

temporary test. A randomised on/off sham controlled

sub-sensory stimulation was provided (8 weeks each

cycle) with no improvement during active stimulation.

At 1 year, only 11 (55%) patients were still responding

[32]. The results of a third study have been recently pre-

sented (nationally and internationally) from a multi-cen-

tre prospective randomised study [ISRCTN44563324].

The main aim of this study was to assess the efficacy of

sham controlled tined lead stimulation as a way of iden-

tifying true responders. Thirty-nine patients were

recruited to the test phase and 27 were implanted with

all but one followed up to 6 months. The findings

showed, once again, that temporary testing has no value

in determining long term response. The response at

6 months was assessed by a reduction of at least 0.5 on

Table 5 Patient baseline phenotypic data.

Authors N Inclusion criteria STC Neurological disease Proctogram

Kamm [23] 62 < 2 bowel movements per week and/or

straining or incomplete emptying > 25%

occasions

50 (81%) Excluded Performed not stratified

Sharma [26] 21 2 or fewer bowel movements per week, failed

conservative treatment over at least

12 months from GP referral

19 (86%) Excluded Performed used to rule out obstructive

defaecation but anismus not exclusion

criterion

Ortiz [24] 48 Rome III criteria, symptoms at least 1 year,

failed conservative treatment with laxatives,

suppositories, enemas and behavioural therapy

5 (10%) Excluded Performed not stratified

Govaert [21] 117 < 2 bowel movements per week and/or

straining or incomplete emptying > 25%

occasions. Persistent symptoms 1 year and

failed conservative treatment (NB includes 26

patients from Kamm study and 38 patients

from Maeda study)

75 (64%) Not excluded Performed not stratified

Khan [27] 22 Patients with neurological disease [including

multiple sclerosis (n = 14) and spinal cord

injury (n = 5)] and severe constipation

refractory to conservative treatment

NR Inclusion criterion None

Ratto [25] 61 Rome III criteria. Patients identified from

GINS: Italian group for sacral nerve

neuromodulation (NB may include some

patients from Ortiz study although not

specifically mentioned)

17 (28%) Not excluded Performed and patients with rectocoele,

intussusception, rectal prolapse and

enterocoele excluded

Graf [28] 44 History of ‘constipation’ for at least 6 months

and failure of conservative treatment

21 (48%) Excluded spinal

cord injury

Selective

Figure 5 Forest plot showing rates of SNS response rate by

level of STC patients (percentage of patients). KEY: STC, slow

transit constipation.




PAC-SYM and this was achieved in 15(55%) of

patients.

These more recent prospective studies suggest that

the efficacy of SNS in constipation may be very limited,

but in particular, that prediction of responders using

various temporary testing regimens is poor. In view of

the cost and risk of the procedure, the inability to pre-

dict responders is likely to hamper the utility of the

treatment in the future.

There was a significant difference in the conclusions

between the largely retrospective early studies, which

supported the use of SNS, and the three recent well-

conducted prospective studies, which have all urged

greater caution. This is an example of the importance

and need for formally planned and robustly executed

studies to inform surgical practice and a warning against

over-reliance on retrospective cohort studies.

Acknowledgements

We would like to acknowledge the following people

in relation to the NIHR CapaCiTY working group:

Mr Steven Brown, Sheffield Teaching Hospitals NHS

Foundation Trust; Mr Kenneth Campbell, The

University of Dundee, NHS Education for Scotland;

Mr Mark Chapman, Heart of England NHS Trust;

Mr Andrew Clarke, Poole Hospital NHS Foundation

Trust; Mr Neil Cruickshank, Sandwell and West Birm-

ingham Hospitals NHS Trust; Mr Anthony Dixon,

University of Bristol, Bristol, UK; Dr Christopher

Emmett, County Durham and Darlington NHS

Foundation Trust; Mr Ugo Grossi, Queen Mary

University of London; Dr Richard Hooper, PCTU,

Queen Mary University of London; Miss Emma

Horrocks, University Hospital Southampton NHS

Foundation Trust; Professor Charles Knowles, Queen

Mary University of London; Mr Jon Lacy-Colson,

Shrewsbury and Telford Hospital NHS Trust; Mr Ian

Lindsey, Oxford University Hospitals NHS Trust;

Professor James Mason, University of Warwick,

Coventry; Mr Mark Mercer-Jones, Gateshead Health

NHS Foundation Trust; Mr Andrew Miller, University


Hospital Germans Trias i Pujol, Barcelona, Spain;

Miss Sophie Pilkington, University Hospital

Southampton NHS Foundation Trust; Mr Neil Smart,

Royal Devon & Exeter NHS Foundation Trust; Ms

Natasha Stevens, PCTU, Queen Mary University of

London; Professor Douglas Tincello, University

Hospitals of Leicester NHS Trust; Miss Karen Tel-

ford, South Manchester NHS Foundation Trust; Mr

Paul Vollebregt, Queen Mary University of London;

Mr Andrew Williams, Guy’s and Thomas’ NHS Foun-

dation Trust; Professor Yan Yiannakou, County

Durham and Darlington NHS Foundation Trust.



Funding







ment of Health.

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Graded practice and future research recommendations

C. H. Knowles*, U. Grossi*, E. J. Horrocks*, D. Pares†, P. F. Vollebregt*, M. Chapman‡,S. Brown§, M. Mercer-Jones¶, A. B. Williams**, Y. Yiannakou††, R. J. Hooper‡‡, N. Stevens‡‡and J. Mason§§, on behalf of the NIHR CapaCiTY working group¶¶, The Pelvic floor Society***

and European Society of Coloproctology†††*National Bowel Research Centre, Blizard Institute, Queen Mary University London, London, UK, †Hospital Germans Tr�ıas i Pujol, Barcelona, Spain,

‡Good Hope Hospital, Heart of England NHS Trust, Birmingham, UK, §Sheffield Teaching Hospitals, Sheffield, UK, ¶Queen Elizabeth Hospital,

Gateshead NHS Trust, Gateshead, UK, **Guy’s and St Thomas’ NHS Foundation Trust, London, UK, ††County Durham and Darlington NHS

Foundation Trust, Durham, UK, ‡‡NIHR Pragmatic Clinical Trials Unit, Blizard Institute, Queen Mary University of London, London, UK, §§University of

Warwick, Coventry, UK, ¶¶National Institute for Health Research: Chronic Constipation Treatment Pathway, ***Affiliate section of the Association of

Coloproctology of Great Britain and Ireland, and †††European Consensus groupa

Abstract

Aim This manuscript forms the final of seven that address

the surgical management of chronic constipation (CC) in

adults. The content coalesces results from the five system-

atic reviews that precede it and of the European Consensus

process to derive graded practice recommendations (GPR).

Methods Summary of review data, development of

GPR and future research recommendations as outlined

in detail in the ‘introduction and methods’ paper.

Results The overall quality of data in the five reviews was

poor with 113/156(72.4%) of included studies providing

only level IV evidence and only four included level I

RCTs. Coalescence of data from the five procedural

classes revealed that few firm conclusions could be drawn

regarding procedural choice or patient selection: no sin-

gle procedure dominated in addressing dynamic struc-

tural abnormalities of the anorectum and pelvic floor

with each having similar overall efficacy. Of one hundred

‘prototype’ GPRs developed by the clinical guideline

group, 85/100 were deemed ‘appropriate’ based on the

independent scoring of a panel of 18 European experts

and use of RAND-UCLA consensus methodology. The

remaining 15 were all deemed uncertain. Future research

recommendations included some potential RCTs but also

a strong emphasis on delivery of large multinational high-

quality prospective cohort studies.

Conclusion While the evidence base for surgery in CC

is poor, the widespread European consensus for GPRs

is encouraging. Professional bodies have the opportu-

nity to build on this work by supporting the efforts of

their membership to help convert the documented rec-

ommendations into clinical guidelines.

Keywords Constipation, surgery, obstructed defaecation

Introduction

This manuscript forms the final of seven that address

the surgical management of chronic constipation in

adults. The content coalesces results from the five sys-

tematic reviews that precede it and of the European

Consensus process to derive graded practice recommen-

dations.

Methods

These have been fully explained in the ‘Introduction

and Methods’ paper. Procedures have been grouped

as:

1 Colonic resection, including total colectomy, sub-

total and segmental colectomy (with some anasto-

motic variations for subtotal colectomy) by open and

laparoscopic approaches;

2 Rectal suspension procedures, including forms of

open and laparoscopic rectopexy;

3 Rectal excisional procedures, including stapled trans-

anal rectal resection (STARR) and intra-anal Delorme’s;

Correspondence to: Professor Charles H. Knowles, NBRC, 1st Floor Abernethy

Building, 2 Newark St, London E1 2AT, UK.


aEuropean Society of Coloproctology members are listed in Appendix 1.







4 Rectovaginal reinforcement procedures, including

trans-vaginal and trans-anal approaches with or with-

out mesh;

5 Sacral nerve stimulation.

Results have been presented as follows:

1 Summary tables of results where these could be com-

pared between classes of procedure based on homo-

geneous outcomes;

2 Graded practice recommendations. All prototype

GPRs have been documented with consensus statis-

tics and thence a clear indication of those that were

upheld (found to be appropriate) by consensus.

A final section addresses implications for future

research. Note: consideration was given to summarizing

all summary evidence statements in this manuscript

however these are covered in each individual review and

were omitted here for brevity.

Results


Table 1 repeats the information provided in the ‘intro-

duction and methods’ paper on overall study character-

istics by procedure. As previously noted, the overall

quality of evidence was poor with 113/156 (72.4%)

providing only level IV evidence. The best evidence was

extracted for rectal excisional procedures where the

majority of studies were level I or II.

Summary of systematic review data

In each of the five reviews, results were presented for

perioperative variables, harms (post-operative complica-

tions and long-term adverse events), efficacy and prog-

nostic factors. These data have been presented together

below.

Perioperative variablesData were available for nearly all procedure classes (except

SNS) on operation duration and length of stay (Table 2,

Figure 1). Not unsurprisingly, colectomy had the longest

operative duration and length of stay. For the three classes

of rectal procedure lengths of stay were similar, however

duration of surgery was clearly longer for rectal suspension

(rectopexy) and shortest for rectal excision - in effect for

forms of stapled trans-anal resection (STARR).

HarmsThere were large discrepancies in harm recording with

selected outcomes being based on a priori knowledge of

recognized harms for each class of procedure. Given con-

siderable heterogeneity in reporting (covered in the indi-

vidual reviews), it was only possible to summarize main

harms semi-quantitatively (Table 3). A mortality rate of

approximately 1/200 occurred after colectomy. Other pro-

cedures had no recorded mortality or a very low rate (rec-

tovaginal reinforcement procedures: 1/1600). Colectomy

was associated with substantial risks in the short and long-

term, particularly in relation to small bowel obstruction

and poor functional outcomes. Other procedures had gen-

erally fewer complications, including some where review

data reflected concerns expressed widely in the interna-

tional surgical community, notably mesh complications

after rectopexy and chronic pain � urgency after STARR.

EfficacyFew variables could be analysed across procedure classes on

the basis that, like harms, outcomes chosen tended to be

bespoke to each procedure class. It was however possible to

summarise global satisfaction ratings, i.e. the proportion of

patients self-reporting a good or excellent outcome.

Accepting the considerable limitations of such outcomes,

data in Table 4 show that all procedures are almost equally-

well received by patients with rates around 70–85% for all.

Table 1 Reviewed studies by main procedure type and evi-

dence level.

Procedure

Number of reviewed studies

by evidence level

1b 2b 3b 4 Total

Colonic resection 0 1 0 39 40

Rectal suspension procedures 0 2 0 16 18

Rectal excisional procedures 3 26 0 18 47

RV reinforcement procedures 1 10 0 33 44

Sacral nerve stimulation 0 0 0 7 7

ALL 4 39 0 113 156

RV, recto-vaginal.

Table 2 Summary of perioperative data for main classes of

procedure.

Procedure

Operation

Duration, mins

Length of Stay

(LOS), days

Mean

Range of

study means Mean

Range of

study means

Colonic resection 167 120–248 10.4 7.0–15.5

Rectal suspension 159 75–198 4.6 1.0–7.1

Rectal excision 44 23–95 3.0 1.0–8.0

RV reinforcement 67 20–169 3.9 1.0–9.0

SNS NK NK NK NK

RV, recto-vaginal; NK, not known.




Patient selectionFor most classes of procedure, some information could

be obtained about prognostic baseline characteristics

that might guide patient selection. In all instances, the

level of evidence was poor with no formal stratified

medicine studies and very few (if any) adequately pow-

ered post-hoc analyses of good quality cohort studies.

Table 5 summarizes the broad phenotypes of patients

that may most benefit from each procedure and some

negative prognostic features.

Graded practice recommendations

A series of tables (Table 6 a-e) show all GPRs proposed by

the clinical guideline group by main procedure class. The

outcomes of the consensus process have been presented as

median score (1–9) and by classification based on RAND-

UCLA methodology: appropriate; uncertain and inappro-

priate. The reader is reminded that appropriateness is not

directly extrapolated from the median score but rather the

overall data distribution (see introduction andmethods).

Discussion

This manuscript summarises the body of data from five

systematic reviews and presents new graded practice

recommendations.

Figure 1 Summary of perioperative data for main classes of

procedure, showing range of study means.

Table 3 Summary of perioperative complications and long-term adverse events

Procedure

Total perioperative

complications* Mortality† Specific adverse events*

Colonic resection 24.4% (17.8–31.7%) 6/1568 (0.4%) Small bowel obstruction: 15.2%, (RE: 10.2% to 20.9%)

Re-op: 13.3%, (RE: 8.6% to 18.7%)

Poor function: abdominal pain, bloating (20–50%),

rec. constipation (10–30%), diarrhea & incontinence (5–15%)

Rectal suspension 9.5% (6.1–13.1%) 0/1044 Minor complications predominate e.g. UTI

Some major poorly documented e.g. SBO

Mesh complications 0.5% (range 0–3.9%)

Rectal excision 16.9% (12.7–21.5%) 0/5896 PO bleeding: 1.6% (0.9% to 2.5%)

Sepsis: 0.2% (0.0% to 0.7%)

Anastomotic dehiscence: 0.3% (0.0% to 0.8%)

Rectal stenosis: 0.2% (0.0% to 0.6%)

Chronic anorectal pain: 0.7% (0.1% to 1.6%)

Chronic urgency: 5.2% (2.7% to 8.2%)

RV reinforcement 11.5% (7.2–16.6%) 2/3209(0.06%) Post-op. bleeding: 2.0% (0.7% to 3.6%)

Haematoma or sepsis: 0.9% (0.2% to 2.0%)

Dyspareunia: inadequately reported to analyse

SNS 22.7% (12.9–34.1%) 0/375 At least one reportable event: 58%

Infection: 0–7%

Device removal: 14.4% (7.8% to 22.5%)

*Pooled estimates based on random effects (RE) models with (95% CI); RV: recto-vaginal.

†denominator represents only those studies where mortality was recorded and documented.




Summary of systematic review data

The overall quality of data was poor with 113/156

(72.4%) of included studies providing only level IV evi-

dence, thus greatly limiting the number and grade of

summary evidence statements. This was a particular prob-

lem for colonic resection, rectal suspension procedures

and sacral nerve stimulation, where nearly all data were

derived from level IV studies. The limitations of such

observational data are well acknowledged and are a

source of concern when used as a basis for promoting

procedures. For instance, colectomy for slow-transit con-

stipation would, based on systematic review of 40 obser-

vational studies, appear to be an attractive prospect with

86% global satisfaction rate (the highest of any of the

studied classes of procedure). However, recently pub-

lished US retrospective cohort data on over 2000

patients [1] paint a very different picture of high compli-

cation rates and greater long-term post-procedural health

utilization (ambulatory care, hospital admissions, radiol-

ogy etc.) than before surgery. It is difficult to reconcile

such disparity [2], and the increasing rates of colectomy

for constipation in the US [1] also seem at odds with

international opinion (that promotes extreme caution).

Sacral nerve stimulation also had generally supportive

observational evidence based on seven included studies.

However, subsequent randomised studies [3,4] directly

contradict these data and most centres no longer offer

SNS for the constipation indication.

Perhaps the greatest area of academic contention in

the pelvic floor community concerns the choice of pro-

cedure to address dynamic structural abnormalities of

the pelvic floor that lead to prolapse and obstructed

defaecation symptoms. The results presented here do

little to help resolve this issue and certainly cannot help

underpin a much needed treatment algorithm for such

patients. In effect, all have similar global satisfaction rat-

ings, similar lengths of stay and complication profiles

that are to some extent procedure-specific. Based on

reviewed indications, rectal suspension and excision pro-

cedures can be applied to patients with rectal intussus-

ception and/or rectocoele and rectovaginal

reinforcement procedures to rectocoele only. Aside

from a generally longer operating time for rectopexy

(and shorter for STARR), decision making for a patient

with one or both of these abnormalities currently rests

with personal views about the acceptability of certain

complications and (possibly) surgeon enthusiasm for

Table 4 Summary of efficacy data based on global satisfaction ratings.

Procedure No studies Total No patients Follow up (mean and range of means, months) Global satisfaction*

Colonic resection 40 2045 47 (12–132) 86 (81–89)%

Rectal suspension 18 1238 25 (12–72) 83 (74–91)%

RV reinforcement 44 3499 25 (12–74) 72 (67–77)%

Rectal wall excision 47 8340 23 (12–66) 76 (73–80)%

SNS 7 375 27 (20–51) 73 (57–87)%

*Pooled estimates based on random effects models with (95% CI).

Table 5 Patient characteristics influencing selection for each class of procedure

Procedure Main positive characteristic Secondary positive characteristics Negative characteristics

Colonic resection Proven slow transit constipation Proven upper GI dysmotility

Proven psychiatric disorder

Inconsistent evidence for combined

defaecation disorder

Rectal suspension High grade intussusception

(Oxford grade III-V)

Solitary rectal ulcer syndrome

(SRUS)Rectocoele

None established

Rectal excision Minimum of 3 ODS symptoms;

Functioning rectocoele

High grade intussusception

(Oxford grade III-V)

None established

Rectovaginal

reinforcement

Functioning and significantly-

sized rectocoele

None established None established

SNS Chronic constipation None established None established

ODS, obstructed defaecation symptoms.




Table 6 (a-e) Graded practice recommendations

Evidence level Grade Median score Decision

(a)

Colonic resection

Patient selection

1. Given uncertainty of outcome and potential for harm, colectomy

should only be offered to patients when all other relevant

treatments have failed

IV C 9 Appropriate

2. Given concerns regarding outcome, the following represent

absolute or relative contra-indications to colectomy

a Concomitant upper GI symptoms (relative) V N 6 Uncertain

b Proven upper GI dysmotility (absolute) IV C 8 Uncertain

c Unproven generalised delay in colon transit (absolute) IV C 8 Appropriate

d Concomitant defecation disorder (relative) IV D 6 Uncertain

e Significant symptoms of abdominal pain and bloating, including diag-

nosis of IBS (relative)

IV D 6 Uncertain

f Faecal incontinence and/or functionally impaired anal sphincter V N 9 Appropriate

3. As a consequence of the above, colectomy should not be

considered without precision phenotyping (clinical and radio-

physiological)

IV C 9 Appropriate

4. Given concerns regarding outcome, magnitude and irreversibility

of colectomy, patients with concomitant defecation disorder

should have this treated first including surgery for structural

causes where relevant

IV D 8 Appropriate

5. All patients considered for colectomy should have specialist

multidisciplinary discussion

V N 9 Appropriate

6. Formal psychological evaluation should be undertaken in all

patients considered for colectomy for constipation

V N 7 Appropriate

7. In view of need for specialist investigations and review, patients

should only undergo colectomy for constipation in centres with

access to appropriate specialist services

V N 9 Appropriate

Procedural considerations

1. Colectomy and ileorectal anastomosis (CIRA) should be

considered the default option considering weight of evidence

compared to other procedures

IV C 8 Appropriate

2. There are insufficient data to conclude that the following provide

certain benefit in terms of clinical outcome in comparison to CIRA

• Subtotal or segmental resection IV C 8 Appropriate

• Subtypes of subtotal resection (caecorectal vs ileosigmoid) IV D 7 Appropriate

• Variations in anastomotic configuration (iso- or anti-peristaltic) IV D 7 Appropriate

• Laparoscopic vs open approach IV D 5 Uncertain

• Tailoring of segmental resections using specialist regional tran-

sit measurements

IV D 6 Uncertain

3. Laparoscopic surgery should be considered in suitable patients

because of:

• Modest reductions in length of stay IV D 8 Appropriate

• Cosmesis and other generally-perceived benefits e.g. reduced

incisional hernia

V N 8 Appropriate

• Possible reduction in long-term small bowel obstruction and

re-operation rates

IV D 8 Appropriate

Patient counselling

1. Approximately 85% patients report some benefit at follow up

greater than 1 year after colectomy

IV C 8 Appropriate






2. Total perioperative complication rates vary greatly but may occur

in approximately 20–30% of colectomy patients regardless of

procedure choice, and include serious life-threatening

complications such as anastomotic leak (5% risk) and mortality

(0.4%)

IV C 8 Appropriate

3. Rates of post-operative ileus or early post-operative adhesional

small bowel obstruction vary greatly but occur in about 5–15% of

patients and about one-third of these patients require re-operation

regardless of procedure choice

IV C 8 Appropriate

4. Long-term adverse events characterized by recurrent episodes of

small bowel obstruction occur in about 10–20% of patients and

may result in a significant burden of re-hospitalization and

frequent recourse to surgery

IV C 8 Appropriate

5. Negative long term functional outcomes persist in a proportion of

patients: diarrhoea and incontinence in about 5–15% of patients;

abdominal pain in 30–50% of patients; recurrent constipation in

10–30% of patients and bloating in 10–40%

IV C 8 Appropriate

6. As a result of immediate and long-term complications,

approximately 5% patients will have a permanent ileostomy

IV C 6 Uncertain

(b)

Rectal suspension procedures

Patient selection

1. Rectal suspension procedures should be considered only for

patients failing appropriate non-surgical treatments

IV D 9 Appropriate

2. Rectal suspension procedures should be considered for patients

with the following anatomical abnormalities in conjunction with

symptoms suggestive of rectal evacuation disorder

• High grade intussusception (recto-anal e.g. Oxford grade: 3–5) IV C 8 Appropriate

• SRUS with associated intussusception IV C 8 Appropriate

3. Diagnosis of anatomical abnormalities should be conducted to a

standard where agreement exists that observed findings can be

deemed pathological based on appropriate normative data (derived

within the department or derived elsewhere but using identical

methodology e.g. for proctographic imaging)

V N 8 Appropriate

4. Given concerns regarding outcome, the following should be

regarded as relative contraindications to rectal suspension

procedures

• Significant psychiatric disorders V N 7 Appropriate

• Significant chronic pain syndromes including IBS V N 8 Appropriate

• Morbid obesity V N 8 Appropriate

• Known hostile abdomen/pelvis V N 8 Appropriate

• Joint hypermobility syndrome (EDS3)/connective tissue disor-

ders

V N 5 Uncertain

5. Patients considered for rectal suspension procedures should have

specialist multidisciplinary discussion

V N 8 Appropriate


should only undergo rectal suspension procedures for constipation

in centres with access to appropriate specialist services

V N 8 Appropriate

7. Rectal suspension procedures (especially those employing mesh)

require special consideration in women who plan to become

pregnant

V N 8 Appropriate







1. There is insufficient current evidence to conclude that any one

rectal suspension procedure is clearly superior to another

IV C 7 Appropriate

2. Laparoscopic surgery should be considered in suitable patients

because of:

• Cosmesis and other generally perceived benefits such as

reduced incisional hernia

V N 8 Appropriate

• Possible reduction in adhesion formation V N 8 Appropriate

• Superior access to the deep pelvis V N 7 Appropriate

3. There is no current evidence to suggest superiority of robotic

surgery over a standard laparoscopic approach

IV D 8 Appropriate

4. Careful consideration should be given to the type of mesh and

fixation

V N 8 Appropriate

Patient counselling

1. Approximately 83% (73–91%) patients report some benefit at

follow up greater than 1 year after rectal suspension procedures

IV C 8 Appropriate


in approximately 5–15% of patients regardless of procedure choice

IV C 8 Appropriate

3. Serious complications such as mesh erosion occur in 0–4% of

patients however no mortality has not been reported

IV C 8 Appropriate

4. The effect on constipation symptoms is highly variable and data

are only available for lap VMR after which most patients (86%)

report an improvement in constipation symptoms

IV C 7 Appropriate

5. In patients with SRUS, ulcer healing is observed in 78% of

patients

IV C 8 Appropriate

(c)

Rectal excisional procedures

Patient selection

1. Rectal excisional procedures should be considered only for

patients failing appropriate non-surgical treatments

II B 9 Appropriate

2. Rectal excisional procedures should be considered for patients

with the following anatomical abnormalities in conjunction with

symptoms suggestive of rectal evacuation disorder

• Minimum of 3 ODS symptoms II B 7 Appropriate

• Rectorectal or rectoanal intussusception only IV D 5 Uncertain

• Rectocele only II B 5 Uncertain

• Rectocele and intussusception II B 7 Appropriate

3. Diagnosis of anatomical abnormalities should be conducted to a

standard where agreement exists that observed findings can be

deemed pathological based on appropriate normative data (derived

within the department or derived elsewhere but using identical

methodology e.g. for proctographic imaging for grade of

intussusception and size/functionality of rectocele)

V N 8 Appropriate

4. Given concerns regarding outcome, the following should be

regarded as relative contraindications to rectal excisional

procedures although none were supported by evidence in the

systematic review

• Significant psychiatric disorders V N 8 Appropriate

• Significant chronic pain syndromes (including IBS) or perceived

susceptibility to chronic post-surgical pain

V N 8 Appropriate

• Concomitant enterocele (because of perceived risk of bowel

injury

V N 9 Appropriate






• Reduced anal sphincter function (because of risk of urgency and

incontinence)

V N 7 Appropriate

• Solitary rectal ulcer syndrome V N 7 Appropriate

• Clear evidence of anal sphincter dyssynergia V N 7 Appropriate

• External rectal prolapse or other significant pelvic organ prolapse

syndrome

V N 9 Appropriate

5. Patients considered for rectal excisional procedures should have

specialist multidisciplinary discussion

V N 9 Appropriate


should only undergo rectal excisional procedures for constipation

in centres with access to appropriate specialist services

V N 8 Appropriate

Procedural consideration

1. The evidence base of procedural choice is dominated by studies of

STARR procedures and all higher quality studies report STARR

outcomes; on this basis, it is reasonable to recommend STARR as

the default excisional procedure

II B 8 Appropriate

2. There is insufficient current evidence to conclude that any one

rectal excisional procedure is clearly superior to another in terms

of efficacy or complications

IV D 7 Appropriate

Patient counselling


follow up greater than 1 year after rectal excisional procedures

II B 7 Appropriate


in approximately 13–22% of patients regardless of procedure

choice

II B 7 Appropriate

3. Significant complications such as sepsis, anastomotic dehiscence

and bleeding occur in in approximately 2% (1–4%) of patients

II B 6 Uncertain

4. Life-threatening complications occur in in approximately 1: 1000

patients however no mortality was reported in recent review of

almost 6000 patients

II B 8 Appropriate

5. The effect on constipation symptoms is highly variable although

approximately 70% patients will obtain a significant reduction in

burden of obstructed defaecation symptoms

II B 7 Appropriate

6. Patients should be warned of long-term adverse functional

outcomes; rates of urgency (10%) and of chronic pain (2%) should

be cited

II B 8 Appropriate

7. Other long-term complications e.g. stenosis (< 1%)and fistula (1

in 1600) are rare

II B 7 Appropriate

(d)

Rectovaginal reinforcement

Patient selection

1. Rectovaginal reinforcement procedures should be considered for

patients with the following anatomical abnormalities in

conjunction with typical symptoms (vaginal bulging or prolapse

and problematic rectal evacuation)

• Significant dimensions (depth) based on clinical � imaging

assessment

IV C 7 Appropriate

• Evidence of functionality (trapping) on dynamic assessment IV C 8 Appropriate






2. Diagnosis of the above should be conducted to a standard where

agreement exists that observed findings can be deemed

pathological based on appropriate normative data (derived within

the department or derived elsewhere but using identical

methodology e.g. for imaging)

V N 8 Appropriate

3. Given concerns regarding outcome the following should be

regarded as relative contraindications to all forms of rectovaginal

reinforcement procedures

• Diagnosis of major psychiatric disorders V N 7 Appropriate

• Significant chronic pain syndromes including IBS V N 7 Appropriate

• Morbid obesity V N 7 Appropriate

• High grade recto-anal intussusception V N 8 Uncertain

4. Procedure-specific relative contraindications should include:

• Vaginal repairs: smoking V N 5 Uncertain

• Transanal repairs: sphincter incompetence, rectal inflammation

or anorectal stenosis

V N 8 Appropriate

5. Patients considered for rectovaginal reinforcement procedures

should have specialist multidisciplinary discussion

V N 9 Appropriate


should only undergo rectovaginal reinforcement procedures for

constipation in centres with access to appropriate specialist services

V N 8 Appropriate

7. Rectovaginal reinforcement procedures require special

consideration in women who plan to become pregnant

V N 8 Appropriate


1. There is insufficient evidence to conclude that any one

rectovaginal reinforcement procedure is clearly superior to another

for the treatment of constipation

IV C 8 Appropriate

2. Evidence derived from other indications for rectovaginal

reinforcement procedures e.g. pelvic organ prolapse syndromes

suggests superiority of vaginal repair (although this has not been

demonstrated in the treatment of constipation)

V N 5 Uncertain

3. Limited evidence suggests that a site specific vaginal repair may

lead to a higher recurrence rate than other surgical approaches

IV C 5 Uncertain

4. There is no evidence that the use of mesh reinforcement in vaginal

or perineal surgery leads to net benefit

IV C 7 Appropriate

Patient counselling


follow up after 1 year after rectovaginal reinforcement procedures

IV C 7 Appropriate


in approximately 7–17% of patients regardless of procedural choice

IV C 8 Appropriate

3. Serious complications such as rectovaginal fistula occur rarely (< 1

in 1000 patients); mortality has been reported in 1 in 1600

patients

IV C 8 Appropriate

4. While dyspareunia may occur with any of the surgical procedures,

the particular risks of a vaginal approach should be discussed with

the patient

IV D 9 Appropriate

5. Evidence derived from other indications for rectovaginal

reinforcement procedures e.g. pelvic organ prolapse syndromes

suggests an increased risk of dyspareunia with a vaginal repair in

conjunction with levatorplasty

V N 7 Appropriate




type of approach and surgical instruments (flippantly

whether the surgeon prefers basic surgical instruments,

laparoscopy or staplers). With respect to complications,

limited reporting prevented much discussion beyond

the importance of counselling patients about established

complications (covered in GPRs). However, it is tempt-

ing to speculate that future stratification might provide

the opportunity to select patients for one or other pro-

cedure e.g. avoiding patients with certain prior pheno-

typic features or modifying risk. An example would be

chronic pain development, where perhaps STARR

should be relatively contra-indicated in patients with

preceding evidence of pain syndromes (e.g. migraine,

fibromyalgia or chronic back pain) or modified using

one of a number of available agents to prevent sensitiza-

tion during surgery e.g. pre-operative gabapentin or

intra-operative ketamine [5]. At the very least the data

provide the opportunity to appraise patients with the

options and their complication profiles where more than

one surgical option exists.

Another difficulty with interpretation was that inclu-

sion (in the review) necessarily reflected the availability

of studies, in turn reflecting the tendency to publish

studies of new techniques rather than well-established

ones. Higher quality data were available for rectal exci-

sional procedures due to several prospective cohort

studies and small RCTs of the STARR procedure (and

variations). It is well acknowledged that this body of

data, including over 8000 patients, reflects a period of

intense popularity for this procedure (nearly all pub-

lished in the decade 2004–14) with (interestingly) no

included papers arising from the final 18 months of the

review period. The large numbers are also known to

reflect industry investment in several data registries, two

of which included over 2000 patients. Anecdotal evi-

dence and expert opinion from international meetings is

that the popularity for this procedure has waned (even

in Italy – the origin of the procedure and its main pro-

ponents). Such a peak and decline in popularity was not

present for other procedures that were more evenly

spread across the review period.

Graded practice recommendations

The clinical guidelines group developed a total of 100

‘prototype’ graded practice recommendations by taking

forward summary evidence statements from the five

reviews and combining these with expert opinion and a

small number of RCTs (SNS only) published after the

extraction data (22/02/2016). These statements cov-

ered patient selection, procedural considerations and

patient counselling. The limitations in review evidence

meant that only 59/100 prototype GPRs were directly

derived from summary evidence (level II-IV; grades B-

D) with the remainder, 41/100 derived by expert opin-

ion only (level V; grade N). Of the 100 total, 85 were

deemed ‘appropriate’ based on the independent scoring

of 18 European experts and the remaining 15 were all



(e)

Sacral nerve stimulation

Patient selection

1. Recent trial data (from 2 independent RCTs) suggest no overall

benefit of SNS for chronic constipation regardless of type of

constipation; on this basis, the procedure cannot be recommended

for this indication

II B 7 Appropriate


1. Not applicable (follow manufacturer’s instructions and specific

training)

NA NA NA NA

Patient counselling

1. Patients should be counselled that the evidence base does not

support the use of SNS for chronic constipation

II B 9 Appropriate

2. If performed, patients should be warned of:

• Highly variable rates of device removal for adverse effects or

lack of efficacy

IV D 8 Appropriate

• Very high rates of reprogramming IV D 8 Appropriate

• Low eventual success rates II B 9 Appropriate




deemed uncertain, i.e. none was considered inappropri-

ate by the panel. This is a high level of consensus for a

single round of questioning and suggests that there is

reasonable European agreement as to selection of

patients for each class of procedure, which procedure to

perform and how to counsel the patient (often related

to outlining potential harms). However, this does not

signify unequivocal evidence of value for these recom-

mendations and they do not represent minimum stan-

dards, but can act as a basis for further research and

guideline development.

The 15 ‘uncertain’ GPRs were spread across proce-

dures with most in colectomy (n = 7) and least for

rectal suspension (1) and SNS (0). The majority con-

cerned patient selection (n = 8). Interestingly, only 5/

15 (33.3%) related to prototype GPRs based only on

expert opinion (level V, grade N). The remaining 10

included five where uncertainty by consensus accurately

reflected uncertainty by grade (D) (33.3%), three with

grade C summary evidence from the systematic reviews

(20.0%) and two with grade B evidence (13.3%).

There was thus no strong suggestion that grade

weighed panelist opinion. The two grade B statements

deemed uncertain both concerned rectal excision: first

that ‘rectocoele only’ was an indication in terms of

benefiting the patient; and secondly that significant

complications such as sepsis, anastomotic dehiscence

and bleeding can occur post-procedure in approxi-

mately 2% (1–4%) of patients. The panelist consensus

on these two GPRs is surprising since both would

seem to reflect widespread practice and knowledge,

respectively. Overall, while it would be possible to

have further rounds of consensus building among the

European panel, the GPRs as stands are a good start

to develop future clinical guidelines.

Future research recommendations

With the exception of rectal excision, there are clear

deficiencies in the current evidence base for all surgical

procedures directed at the management of chronic con-

stipation in adults. This was particularly true in terms of

availability of randomized controlled trials, where only

four reviewed studies met criteria for level I evidence.

The difficulties in conducting randomized trials for

complex interventions such as surgery are well rehearsed

[6], but their importance is exemplified by recent SNS

RCTs [3,4] that directly contradict observational data.

While it can be argued that sham surgery would be dif-

ficult to justify for patients with a chronic debilitating

condition, it is disappointing that no level I evidence

has been produced to compare classes of procedure

where more than one is appropriate. Such comparison

trials of different techniques may face problems of equi-

poise and interventional fidelity, and might need to

overcome a speciality divide e.g. posterior repair vs

transanal repair of rectocoele (the former performed lar-

gely by gynaecologists or urologists specializing in

female patients and the latter by colorectal surgeons).

An alternative is waiting-list designs where the wait time

for surgery can be randomized and analysis-based on

longitudinal outcomes before and after intervention [7].

An example of such a study is the CapaCiTY03

stepped-wedge randomised controlled study of laparo-

scopic ventral mesh rectopexy in adults with chronic

constipation [8].

Accepting the difficulty in performing RCTs, there is

still much opportunity to improve the evidence base by

encouraging high quality observational studies. Prospec-

tive cohort studies could benefit from incorporating

some of the scientific rigor of RCTs to limit obvious

sources of bias e.g. by multicentre recruitment and use

of blinded observers to collect outcomes. Awareness of

reporting standards by authors and journals may in turn

feed better protocol-driven research [9]. They should

incorporate the few validated patient-reported outcome

measures (PROMS) that are available e.g. PAC-QoL

and PAC-SYM, internationally-accepted HR-QoL mea-

sures e.g. EQ-5D-5L and monitor harms in a systematic

manner using established systems e.g. Clavien-Dindo

[6]. They should also consider collecting health utiliza-

tion data from patient information systems, the impor-

tance of which is illustrated by the Dudekula study [1]

of colectomy.

The CCG make the following recommendations as

research priorities:

1 Colonic resection: there is a need to determine

prospectively and robustly the risks and benefits of

this procedure. Considering its low incidence, a

prospective cohort study across Europe (or interna-

tionally) is recommended. Observer-blinded out-

comes (above) should be systematically recorded at

regular intervals to 5 years. Standardised baseline

phenotyping may permit determination of outcome

predictors if numbers are large enough. Considera-

tion could be given to a control group not undergo-

ing surgery (although selection bias is

acknowledged). All procedural variations could be

evaluated although the main comparison of interest

is now considered to be between more (total colec-

tomy) and less radical (subtotal) laparoscopic resec-

tions. A double-blind RCT of this latter comparison

might also be possible with international effort.

2 Rectal procedures for dynamic structural abnormali-

ties of the pelvic floor. A UK RCT is underway to

evaluate laparoscopic ventral mesh rectopexy [8]. A




further RCT is however recommended to determine

outcomes of repair of large rectocoele (in isolation),

comparing posterior repair of the vagina vs transanal

repair. It is acknowledged that this might require an

expertise-based design [6,10] but it is an unanswered

question for the indication of chronic constipation or

obstructed defaecation. Systematic review data would

also support a randomized comparison of STARR

with rectopexy for patients with high-grade intussus-

ception and rectocoele. However, expert opinion sug-

gests that STARR is no longer popular. An alternative

would be to perform a prospective cohort study (akin

to colectomy) capturing all current practice. This

could be performed internationally but might also be

possible in a single country where all three main

classes of procedure are still commonly utilized.

Conclusions

This manuscript concludes the series of seven, systemat-

ically detailing the outcomes of the main surgical proce-

dures directed toward patients with chronic

constipation. The current evidence base is poor and

heavily reliant on low-quality observational data. On

this basis, all procedures reviewed had generally positive

(supportive) data. Several authors expressed concern

that such data might not reflect the reality of clinical

practice. While bias in such observational study designs

is well recognized, it is possible that in surgical studies

(usually performed by the proponents of the surgery)

bias is both unidirectional (favouring the intervention)

and powerful. Not only should this lead to a greater

willingness to design and deliver high quality controlled

trials, but also to an essential understanding that retro-

spective observational studies should be interpreted with

caution. However the finding of widespread consensus

for graded practice recommendations is encouraging.

The stage is now set for recognised professional bodies

worldwide e.g. Societies of Coloproctology/Colorectal

surgery to build on this work by supporting the efforts

of their membership to address future research recom-

mendations and/or to help convert the recommenda-

tions documented in this series of papers into their

clinical guidelines.

Acknowledgments


































Foundation Trust.


All authors have no conflict of interest in relation to the

content of the manuscript. In the last 2 years, C.H.

Knowles has received speaker fees and consultancy pay-

ments from Medtronic Inc., S. Brown has received

speaker fees and consultancy payments from Allergan,

A.B. Williams has received speaker fees and consultancy

payments from Medtronic Inc. and acts as a nonpayed

consultant for Cook Medical, Y. Yiannakou has received

speaker fees and consultancy payments from Movetis

and Enteromed, and M. Mercer-Jones has received fees

as a preceptor for Medtronic Inc. Mark Chapman has

received funding to attend courses from Medtronic Inc.

Funding







ment of Health.




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9 von Elm E, Altman DG, Egger M et al. The Strengthening

the Reporting of Observational Studies in Epidemiology

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Appendix 1

European Consensus group authorship: Donato Alto-

mare, Lars Boenicke, Steen Buntzen, Ken Campbell,

Peter Christensen, Andre D’Hoore, Eloy Espin, David

Jayne, Oliver Jones, Jens-Christian Knapp, Soren Lau-

rberg, Paul Lehur, Klaus Matzel, Ronan O’Connell,

Michel Prudhomme, Carlo Ratto, Mario Trompetto, and

Carolynne Vaizey.






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