E U R O P E A N U R O L O G Y 6 7 ( 2 0 1 5 ) 6 6 0 – 6 7 0

avai lable at www.sciencedirect .com

journal homepage: www.europeanurology.com

Platinum Priority – Prostate CancerEditorial by Prokar Dasgupta on pp. 671–672 of this issue

Short-term Results after Robot-assisted Laparoscopic Radical

Prostatectomy Compared to Open Radical Prostatectomy

Anna Wallerstedt a,*, Stavros I. Tyritzis a, Thordis Thorsteinsdottir b,c, Stefan Carlsson a,Johan Stranne d, Ove Gustafsson e, Jonas Hugosson d, Anders Bjartell f, Ulrica Wilderang b,N. Peter Wiklund a, Gunnar Steineck b,g, Eva Haglind h,

on behalf of the LAPPRO steering committee

a Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Solna, Stockholm, Sweden; b Division of Clinical Cancer

Epidemiology, Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden; c Faculty of

Nursing, School of Health Sciences, University of Iceland, Reykjavik, Iceland; d Department of Urology, Institute of Clinical Sciences, Sahlgrenska Academy at

the University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden; e Department of Clinical Science, Intervention and Technology,

Karolinska Institutet, Solna, Stockholm, Sweden; f Department of Urology, Skane University Hospital, Lund University, Lund, Sweden; g Department of

Oncology and Pathology, Division of Clinical Cancer Epidemiology, Karolinska Institutet, Solna, Stockholm, Sweden; h Department of Surgery, Institute of

Clinical Sciences, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden

Article info

Article history:Accepted September 23, 2014

Keywords:

Radical prostatectomy

Open

Robot-assisted

Complications

Short-term results

Abstract

Background: Robot-assisted laparoscopic radical prostatectomy has become a wide-spread technique despite a lack of randomised trials showing its superiority over openradical prostatectomy.Objective: To compare in-hospital characteristics and patient-reported outcomes at3 mo between robot-assisted laparoscopic and open retropubic radical prostatectomy.Design, setting, and participants: A prospective, controlled trial was performed of allmen who underwent radical prostatectomy at 14 participating centres. Validatedpatient questionnaires were collected at baseline and after 3 mo by independenthealth-care researchers.Outcome measurements and statistical analysis: The difference in outcome between thetwo treatment groups were analysed using logistic regression analysis, with adjustmentfor identified confounders.Results and limitations: Questionnaires were received from 2506 (95%) patients. Therobot-assisted surgery group had less perioperative bleeding (185 vs 683 ml, p <0.001)and shorter hospital stay (3.3 vs 4.1 d, p< 0.001) than the open surgery group. Operatingtime was shorter with the open technique (103 vs 175 min, p < 0.001) compared withthe robot-assisted technique. Reoperation during initial hospital stay was more frequentafter open surgery after adjusting for tumour characteristics and lymph node dissection(1.6% vs 0.7%, odds ratio [OR] 0.31, 95% confidence interval [CI 95%] 0.11–0.90). Men whounderwent open surgery were more likely to seek healthcare (for one or more of22 specified disorders identified prestudy) compared to men in the robot-assistedsurgery group ( p = 0.03). It was more common to seek healthcare for cardiovascularreasons in the open surgery group than in the robot-assisted surgery group, afteradjusting for nontumour and tumour-specific confounders, (7.9% vs 5.8%, OR 0.63, CI95% 0.42–0.94). The readmittance rate was not statistically different between the

r. Department of Molecular Medicine and Surgery, Section of Urology,lna, Stockholm, Sweden.

* Corresponding authoKarolinska Institutet, So

E-mail address: anna.walle

http://dx.doi.org/10.1016/j.eururo.2014.09.0360302-2838/# 2014 European Association of Urology. Published by Elsevier

rstedt@karolinska.se (A. Wallerstedt).

B.V. All rights reserved.

groups. A limitation of the study is the lack of a standardised tool for the assessment ofthe adverse events.Conclusions: This large prospective study confirms previous findings that robot-assistedlaparoscopic radical prostatectomy is a safe procedure with some short-term advantagescompared to open surgery. Whether these advantages also include long-term morbidityand are related to acceptable costs remain to be studied.Patient summary: We compare patient-reported outcomes between two commonlyused surgical techniques. Our results show that the choice of surgical technique mayinfluence short-term outcomes.

# 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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1. Introduction

Surgery-induced problems in the short term may cause

suffering for the patient and increased costs for the health

care system. Arguments for the introduction of laparoscopic

techniques include the contention that a smaller wound, as

compared to that produced by open surgery, would result in

less bleeding and fewer infections as well as a shorter length

of hospital stay. Evolving data supporting these assump-

tions and experiences suggest that the same pattern may

hold for robot-assisted laparoscopic radical prostatectomy

as compared with open surgery [1–3].

There are currently no large prospective studies com-

paring the short-term results of robot-assisted laparoscopic

prostatectomy and open radical prostatectomy. The mag-

nitude of the probable improvement in short-term outcomes

through use of the robot-assisted technique is, therefore, still

unknown, as is the effect on short-term outcomes other than

infections, bleeding, and length of hospital stay [4,5].

In order to assess potential differences between the two

types of procedure, we initiated a prospective controlled

trial at 14 centres in Sweden performing radical prostatec-

tomy, collecting information from both health-care profes-

sionals and patients. The aim of this study was to report the

frequency of certain prespecified short-term results and

adverse events after both robot-assisted laparoscopic

radical prostatectomy and open retropubic radical prosta-

tectomy, and to investigate potential differences between

the two procedures.

2. Patients and methods

2.1. Overview

This prospective controlled trial, LAPPRO (Laparoscopic Prostatectomy

Robot Open), recruited patients from seven centres using the robot-

assisted approach and seven centres performing open surgery. Patient-

reported data were collected before and 3 mo after surgery by a neutral

third-party trial secretariat. Health-care professionals completed clinical

record forms before, during, and 1.5–3 mo, 12 mo, and 24 mo after

surgery. The time point for measuring adverse events on patient reports

was set at 3 mo postoperatively. Further details can be found in the

publication describing the study [6] and in the protocol available

on www.ssorg.net. The Regional Ethical Review Board in Gothenburg

(No 277-07) approved the study. The trial is registered in the Current

Controlled Trials database (ISRCTN06393679).

LAPPRO is an external scientific review of the two surgical

techniques, as neither the principal investigator (E.H.) nor the deputy

principal investigator (G.S.) is a urologist and neither performs radical

prostatectomies. The prespecified statistical analysis plan is available as

supplementary material.

2.2. Patients

To avoid problems due to physician selection, we aimed to collect

data from all men diagnosed with prostate cancer and planned for

radical prostatectomy at the 14 participating centres from September 1,

2008 to November 7, 2011. For a majority of those participating,

geographical residency decided the technique used, not patient or

surgeon preferences. For this report, the inclusion criteria were age <75

yr, ability to read and write Swedish, informed consent, tumour stage

cT1, cT2, or cT3 (TNM Classification of Malignant Tumors) [7] with no

signs of distant metastases, and a prostate-specific antigen level of <20

ng/ml. To diminish the influence of the learning curve, we only included

men who were operated on by a surgeon with experience of at least

100 procedures as primary surgeon.

2.3. Data collection

The study-specific clinical record forms were tested face-to-face with

relevant health-care professionals. The study questionnaires reporting

patient outcomes have the same clinometric approach as a previous

randomised controlled trial, and more than 20 large data collections of

cancer survivors [8]. The basic idea was to categorise symptoms and

other phenomena by asking questions about them one by one [9]. The

validation of the questionnaires and the pilot study performed before the

start of the study has been described earlier [6]. During the trial, research

nurses and surgeons filled out the clinical record forms. The centres were

regularly asked to supply missing information and to check suspected

outliers. Two research nurses monitored the recruiting sites. The

preoperative questionnaire was given to the patient before surgery

and collected at the recruiting departments. The 3-mo questionnaires

were sent from the trial secretariat [6] (Table 1).

At 3 mo, we asked ‘‘Have you been readmitted to the hospital after the

surgery?’’ with answer categories ‘‘Yes’’ and ‘‘No’’. The patient could then

specify in free text the reason for readmittance. This information was

classified into different groups in a blinded fashion (Table 2). The question

‘‘Have you sought medical care because of any of the following disorders

after surgery?’’ had 22 specified disorders as answer categories, followed

by ‘‘Yes’’ and ‘‘No’’ options. From this question, we calculated the

probability of seeking health care by dichotomising between ‘‘never’’ and

‘‘once or more’’.

During the recruitment period, a number of quality assurance efforts

were made regarding the data. The information was entered manually

into electronic files. Approximately 1% of the records and questionnaires

were entered twice and compared.

2.4. Statistical analysis

The statistical analysis plan defines the outcomes for this article, effect

measures, and possible confounders and mediators, as well as certain

Table 1 – Baseline characteristics of the patients a,d

Variable Open surgery b

(n = 778)Robot-assisted surgery c

(n = 1847)p value

Age at surgery (yr)

Median 63 (42–75) 63 (37–75) 0.03

Quartiles 59–67 58-66

Educational level, n (%)

University/college (>13 yr in school) 246 (35.5) 691 (42.4) 0.009

Technical training school (12–13 yr in school) 80 (11.5) 184 (11.3)

High school (10–12 yr in school) 208 (30.0) 462 (28.3)

Elementary school (�9 yr in school) 143 (20.6) 254 (15.6)

Other 14 (2.0) 30 (1.8)

Not stated 3 (0.4) 9 (0.6)

ASA e classification number, n (%)

I 508 (66.6) 1113 (60.4) 0.005

II 218 (28.6) 646 (35.0)

III 15 (2.0) 43 (2.3)

Not stated 22 (2.9) 42 (2.3)

Body mass index (kg/m2)

Median (range) 26.2 (18.2–38.2) 25.9 (18.8–54.3) 0.03

Quartiles 24.5–28.1 24.1–28.0

Not stated 12 32

Preoperative PSA (ng/ml)

Median (range) 6.2 (0.7–20.0) 6.1 (0.09–20.0) 0.73

Quartiles 4.5–9.0 4.5–8.9

Not stated (n) 19 8

Clinical tumour stage number, n (%)

T1 494 (64.7) 1099 (59.6) 0.006

T2 218 (28.6) 652 (35.4)

T3 27 (3.5) 57 (3.1)

Not stated 24 (3.2) 36 (2.0)

Gleason score biopsy

�7 716 (93.8) 1732 (93.9) 0.72

�8 45 (5.9) 102 (5.5)

Not stated 2 (0.3) 10 (0.5)

Total length of cancer in prostate biopsy (mm)

Median (interquartile range) 7.0 (3.2–14.9) 7.5 (4.0–16.0) 0.03

Not stated (n) 78 92

Postoperative prostate weight, n (%)

0–19 g 4 (0.5) 18 (1.0) 0.003

20–39 g 267 (35.5) 782 (42.9)

40–59 g 334 (44.4) 729 (40.0)

60–79 g 96 (12.8) 209 (11.5)

�80 g 51 (6.8) 86 (4.7)

Neurovascular bundle–preserving procedure, n (%)

Yes 516 (67.8) 1556 (84.4) <0.001

No 244 (32.1) 284 (15.4)

Not stated 1 (0.1) 3 (0.2)

Lymph node dissection, n (%)

Extended 48 (6.3) 162 (8.8) <0.001

Limited 155 (20.4) 63 (3.4)

Not done 554 (72.8) 1607 (87.2)

Not stated 4 (0.5) 11 (0.6)

Median time between surgery and answering of 3-mo questionnaire (mo)

Median (range) 3.1 (3.1–9.3) 3.1 (3.1–12.4) 0.74

Quartiles 3.1–3.1 3.1–3.1

Not stated (n) 88 194

PSA = prostate-specific antigen.a Total may not add up to 100 due to rounding of percentages.b Denotes retropubic radical prostatectomy.c Denotes robot-assisted laparoscopic radical prostatectomy.d No statistical difference was found between the occurrence of diabetes, cardiovascular disease, pulmonary disease, kidney disease, previous abdominal surgery,

and previous transurethral resection of the prostate (TURP).e ASA classification: I = normal healthy patient; II = mild systemic disease; III = severe systemic disease.

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sensitivity analyses. A power calculation was done to detect a difference on

the primary endpoint of the LAPPRO study; urinary leakage at 12 mo

(significance level p = 0.05, 80% power, two-sided test). All the outcomes

for the short-term results were defined before the start of the study, which

reduces the risk of differences that arise by chance. However, no

adjustment was made for multiple testing, which is a limitation of the

study.

Missing information on prostate weight was imputed by making a

linear regression model of postoperative prostate weight, as predicted by

preoperative prostate volume among men for whom information was

Table 2 – Possible associated factors for patient-reported readmission to hospital after open surgery and robot-assisted surgery a

Factor Group Readmissions, n (%) RR (95% CI) Age-adjusted RR (95% CI)

Age at surgery

37–59 yr 61 (8.0) 1.0 NA

60–69 yr 135 (9.1) 1.14 (0.85–1.52) NA

70–75 yr 24 (9.3) 1.16 (0.74–1.82) NA

Body mass index (kg/m2)

�30 172 (8.8) 1.0 1.0

>30 19 (8.0) 0.92 (0.58–1.44) 0.91 (0.58–1.44)

Preoperative PSA

<4.5 ng/ml 33 (5.6) 1.0 1.0

4.5–6.1 ng/ml 64 (9.8) 1.75 (1.17–2.62) 1.73 (1.15–2.60)

6.2–9.1 ng/ml 55 (8.4) 1.49 (0.98–2.26) 1.47 (0.96–2.23)

�9.2 ng/ml 63 (10.9) 1.95 (1.30–2.92) 1.89 (1.25–2.85)

Lymph node dissection

No 157 (7.6) 1.0 1.0

Yes 60 (14.2) 1.86 (1.41–2.45) 1.82 (1.38–2.41)

Prostate weight

0–19 g 1 (4.6) 0.66 (0.10–4.53) 0.68 (0.10–4.71)

20–39 g 68 (6.9) 1.0 1.0

40–59 g 100 (9.7) 1.41 (1.05–1.89) 1.38 (1.02–1.86)

60–79 g 26 (8.9) 1.29 (0.84–1.99) 1.25 (0.80–1.93)

�80 g 19 (14.4) 2.08 (1.30–3.35) 1.98 (1.21–3.22)

Clinical tumour stage

T1 115 (7.6) 1.0 1.0

T2 85 (10.2) 1.35 (1.03–1.76) 1.32 (1.01–1.73)

T3 14 (18.2) 2.40 (1.45–3.98) 2.36 (1.43–3.92)

Tumour stage of prostatectomy specimen

pT2 138 (7.9) 1.0 1.0

pT3 71 (10.5) 1.34 (1.02–1.76) 1.32 (1.00–1.74)

pT4 3 (23.1) 2.94 (1.08–8.04) 2.82 (1.02–7.75)

Gleason score for biopsy cores

�7 196 (8.4) 1.0 1.0

�8 18 (12.7) 1.51 (0.96–2.37) 1.44 (0.91–2.28)

Gleason score for pathologic specimen

�7 177 (8.1) 1.0 1.0

�8 25 (15.5) 1.92 (1.31–2.83) 1.88 (1.27–2.79)

IPSS irritative symptoms preoperatively

Mild (0–7) 90 (7.3) 1.0 1.0

Moderate (8–19) 78 (9.5) 1.29 (0.97–1.73) 1.25 (0.94–1.68)

Severe (20–35) 16 (11.2) 1.53 (0.92–2.53) 1.47 (0.89–2.44)

Mental disorder

No 178 (8.3) 1.0 1.0

Yes 15 (19.2) 2.32 (1.44–3.73) 2.48 (1.54–3.98)

RR = relative risk; CI = confidence interval; NA = not applicable; PSA = prostate-specific antigen; IPSS = International Prostate Symptom Score.a Postoperative irradiation, inguinal hernia, transurethral resection of the prostate (TURP), coronary bypass surgery, diabetes, cardiovascular disease, pulmonary

disease, neurologic disease, and kidney disease did not significantly affect the risk of readmission.

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available for both variables. Imputation was performed in R utilizing

Multiple Imputations by Chained Equations (MICE) [10] from a data subset

which included the confounders, but listed as possible confounders only.

The required variables were added to each imputed dataset.

Possible confounders for each endpoint were selected from

20 probable risk factors as the variables statistically significantly

associated ( p <0.20) with each specific outcome in over half of the

imputed datasets. Relative risks were the percentage of patients with

that specific outcome in the robot-assisted laparoscopic group divided by

the percentage of patients with that outcome in the open surgery group.

The unadjusted relative risks were completed using log binomial

regression models, which also provided the 95% confidence intervals

(CI 95%). In addition, we provided odds ratios (OR), modelled by logistic

regression, with the adjusted ratios calculated as a pooled estimate from

the 50 imputed datasets. The calculations were performed using the

GENMOD procedure in SAS 9.3 for Windows (SAS Institute Incorporated,

Cary, NC, USA). To compare the occurrence of possible confounders in

the robot-assisted laparoscopic group with the open-surgery group, we

calculated p values by chi-square test or Wilcoxon rank-sum test, where

appropriate.

In the present study, we report the results unadjusted and after

three different adjustments (A, B, and C), where adjustment A is the

use of stringent confounders which are not likely to affect the surgical

technique differently in the two groups, thus only affecting the

outcome as true confounders (Tables 3, 4 and 5). Adjustment B refers

to all factors in A with the addition of tumour-related factors that are

confounders, but may also be mediating factors, since they may affect

the surgery differently in the respective surgical groups. Adjustment

C refers to A and B with the addition of lymph node dissection, which

should also be considered a confounder, but may also be a mediating

factor due to differences in technique in the respective surgical

groups.

3. Results

We collected data from 4003 men; 980 were excluded

because their surgeon had performed <100 operations, and

398 were excluded for not meeting inclusion criteria and for

other causes, as stated in the flow chart (Fig. 1). Of

Table 3 – Comparison between open surgery and robot-assisted surgery concerning parameters during hospital stay a

Variable Open surgery b

Mean (range)Median (IQR)

Robot-assisted surgery c

Mean (range)Median (IQR)

p value

Perioperative bleeding (ml) 683 (50–8000)

550 (350–800)

185 (0–5200)

100 (50–200)

<0.001

OR d time (min) 103 (40–428)

89 (74–125)

175 (45–575)

168 (144–201)

<0.001

Time in recovery unit (h) 6.7 (1–90)

4.0 (2.8–7.0)

4.5 (0–45)

4.0 (3.0–5.0)

0.054

Length of hospital stay (d) 4.1 (1–17)

4 (3–5)

3.3 (2–53)

3 (2–4)

<0.001

Open surgery, b

n (%)Robot-assisted

surgery, c

n (%)

Unadjusted RR(CI 95%)

UnadjustedOR (CI 95%)

Adjusted for nontumourconfounders d,e

OR (CI 95%)

Adjusted forA + tumour-specific

confounders f

OR (CI 95%)

Adjusted forA + B + lymph

node dissection g

OR (CI 95%)

Reoperation during

initial hospital stay

8 (1.6) 13 (0.7) 0.47 (0.20–1.13)

0.47 (0.19–1.13) 0.46 (0.19–1.14) 0.32 (0.12–0.90) 0.31 (0.11–0.90)

Mortality during

hospital stay

0 (0) 0 (0) NA NA NA NA

OR time = operating room time ‘‘skin to skin’’; IQR = interquartile range; RR = relative risk; CI = confidence interval; NA = not applicable.a Total may not add up to 100 due to rounding of percentages.b Denotes retropubic radical prostatectomy.c Denotes robot-assisted laparoscopic radical prostatectomy.d Possible confounders to be used in adjustments for each outcome were selected as variables significantly associated (p value <0.20) with the specific outcome.e Adjustment A: employment status preoperatively, postoperative irradiation, previous operation for inguinal hernia, previous transurethral resection of the

prostate (TURP), pulmonary disease, mental disorder, or kidney disease.f Adjustment B: Adjustment A + tumour factors (preoperative prostate-specific antigen level, clinical tumour stage, tumour stage of prostatectomy specimen,

Gleason score on biopsy cores, Gleason score pathology on specimen).g Adjustment C: Adjustment A + B + lymph node dissection.

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2625 eligible men, 778 were operated on by open surgery

and 1847 by robot-assisted surgery. Altogether, 2506 (95%)

men were evaluated for short-term results and adverse

events. Table 1 shows the baseline characteristics of the

participants. Men operated on by the robot-assisted

procedure more often had university or college education,

a higher American Society of Anesthesiology Classification

score, higher clinical tumour stages and longer total length

of cancer in the prostate biopsies. Nerve-sparing surgery

was more often done during robot-assisted procedures,

even after adjustment for tumour characteristics. Limited

lymph node dissection was significantly more common

during open procedures, whereas extended lymph node

dissection was more common in the robot-assisted group.

The occurrence of diabetes, cardiovascular disease, pulmo-

nary disease, kidney disease, previous abdominal surgery,

previous transurethral resection of the prostate (TURP), and

mental disorder was not statistically different between the

two groups.

As shown in Table 2, we investigated predictors of

patient-reported readmission to hospital. Factors that

significantly increased the risk of readmission included

preoperative prostate-specific antigen level, lymph node

dissection, prostate weight, clinical tumour stage, tumour

stage of prostatectomy specimen, Gleason score on

pathology specimen, and a history of mental disorder.

No deaths occurred during the hospital stay (Table 3).

Three patients died within 3 mo of surgery in the robot-

assisted laparoscopic group, and no one died in the open

radical prostatectomy group, which resulted in no statisti-

cally significant difference ( p = 0.56). A statistically signifi-

cant difference between the groups was found for the amount

of perioperative bleeding (185 vs 683 ml, p < 0.001) and

length of hospital stay (3.3 vs 4.1 days, p < 0.001), in

favour of the robot-assisted technique. Operating time was

longer in the robot-assisted group compared to the open

technique (103 vs 175 min, p < 0.001). Reoperation during

initial hospital stay was significantly more frequent after

open surgery (1.6%) versus the robot-assisted technique

(0.7%) when adjusting for tumour factors and lymph node

dissection, with OR 0.31 (CI 95% 0.11–0.90) (Table 3).

The adverse events that occurred within 3 mo after the

surgery are presented in five groups: infection, cardiovascu-

lar, surgical, gastrointestinal, and psychological (Table 4).

During the study period, men operated on by the open

technique were more likely to seek healthcare compared to

men operated on by the robot-assisted technique, p = 0.03. It

was significantly more common to seek healthcare for

cardiovascular reasons in the open group after adjusting for

nontumour and tumour-specific confounders (OR 0.63, CI

95% 0.42–0.94). Gastrointestinal and psychological reasons

for seeking health care were significantly more frequent in

the open group (OR 0.77, CI 95% 0.62–0.97 vs OR 0.76, CI 95%

0.60–0.96). The significance was sustained for psychological

reasons after adjusting for nontumour and tumour-specific

confounders (Table 4).

Readmittance within 3 mo was not statistically different

between the techniques (Table 5).

Table 4 – Comparison between open and robot-assisted surgery concerning patient-reported adverse events 3 mo after surgery a

Adverse event Opensurgery, b

n (%)

Robot-assistedsurgery, c

n (%)

UnadjustedRR

(CI 95%)Unadjusted OR

(CI 95%)

Adjusted fornontumour

confounders d,e

OR (CI 95%)

Adjusted forA + tumour-specific

confounders f

OR (CI 95%)

Adjusted forA + B + lymph

node dissection g

OR (CI 95%)

Infection 121 (16.4) 309 (17.6) 1.08 (0.89–1.31)

1.09 (0.87–1.38) 1.03 (0.81–1.32) 0.91 (0.70–1.18) 0.90 (0.69–1.18)

Infection in the

operation wound

42 (5.6) 59 (3.3) – – – –

Pneumonia 5 (0.7) 8 (0.5) – – – –

Urinary tract infection 89 (11.9) 262 (14.8) – – – –

Cardiovascular 58 (7.9) 101 (5.8) 0.74 (0.54–1.01)

0.72 (0.52–1.01) 0.69 (0.47–1.00) 0.63 (0.42–0.94) 0.65 (0.43–1.00)

Pulmonary embolism 6 (0.8) 5 (0.3) – – – –

Hypertension 34 (4.6) 70 (4.0) – – – –

Acute myocardial

infarction

1 (0.1) 2 (0.1) – – – –

Arrhythmia or other

heart diseases

12 (1.6) 24 (1.4) – – – –

Deep venous thrombosis 14 (1.9) 4 (0.2) – – – –

Stroke 0 (0.0) 0 (0.0) – – – –

Surgical 187 (25.2) 392 (22.3) 0.88 (0.76–1.03)

0.85 (0.70–1.04) 0.84 (0.67–1.04) 0.81 (0.64–1.03) 0.85 (0.66–1.08)

Pain in the operation

wound

49 (6.6) 42 (2.4) – – – –

Pain in the lower

abdomen

58 (7.8) 149 (8.4) – – – –

Pain in the upper

abdomen

20 (2.7) 57 (3.2) – – – –

Bleeding from the

operation wound

37 (5.0) 46 (2.6) – – – –

Bleeding from the

urinary tract

66 (8.8) 162 (9.2) – – – –

Inguinal hernia 14 (1.9) 33 (1.9) – – – –

Catheter blockage 58 (7.8) 100 (5.7) – – – –

Gastrointestinal 138 (18.7) 264 (15.1) 0.81 (0.67–0.97)

0.77 (0.62–0.97) 0.78 (0.61–1.01) 0.76 (0.60–1.01) 0.77 (0.58–1.03)

Nausea 17 (2.3) 35 (2.0) – – – –

Impaired appetite 37 (5.0) 64 (3.6) – – – –

Loose or frequent stools 48 (6.4) 99 (5.6) – – – –

Constipation 84 (11.2) 138 (7.8) – – – –

Psychological 122 (16.6) 228 (13.1) 0.79 (0.64–0.97)

0.76 (0.60–0.96) 0.81 (0.62–1.06) 0.72 (0.53–0.96) 0.78 (0.58–1.06)

Depressed mood 92 (12.3) 156 (8.8) – – – –

Worry 94 (12.6) 187 (10.6) – – – –

OR = odds ratio; RR = relative risk; CI = confidence interval.a Total may not add up to 100 due to rounding of percentages.b Denotes retropubic radical prostatectomy.c Denotes robot-assisted laparoscopic radical prostatectomy.d Possible confounders to be used in adjustments for each outcome were selected as variables significantly associated ( p value <0.20) with the specific outcome.e Adjustment A. Readmission adjusted for: employment status preoperatively, International Prostate Symptom Score (IPSS), neurologic disease, mental disorder,

kidney disease, and prostate weight. Infection adjusted for: previous transurethral resection of the prostate (TURP), IPSS, cardiovascular disease, pulmonary disease,

neurologic disease, mental disorder, and prostate weight. Cardiovascular adjusted for: age at surgery, educational level, employment status preoperatively, body

mass index (BMI), IPSS, diabetes, cardiovascular disease, pulmonary disease, mental disorder, prostate weight. Surgical adjusted for: employment status

preoperatively, BMI, IPSS score, IPSS, cardiovascular disease, pulmonary disease, mental disorder, kidney disease, and prostate weight. Gastrointestinal adjusted for:

age at surgery, educational level, employment status preoperatively, BMI, postoperative irradiation, coronary bypass surgery, smoking, IPSS, diabetes,

cardiovascular disease, pulmonary disease, mental disorder, and prostate weight. Psychological adjusted for: age at surgery, educational level, employment status

preoperatively, physical exercise, postoperative irradiation, coronary bypass surgery, smoking, IPSS, mental disorder, and prostate weight.f Adjustment B: Adjustment A + tumour factors (preoperative prostate-specific antigen level, clinical tumour stage, tumour stage of prostatectomy specimen,

Gleason score on biopsy cores, and Gleason score pathology on specimen).g Adjustment C: Adjustment A + B + lymph node dissection.

E U R O P E A N U R O L O G Y 6 7 ( 2 0 1 5 ) 6 6 0 – 6 7 0 665

4. Discussion

In this prospective controlled trial comparing robot-

assisted laparoscopic and open retropubic radical prosta-

tectomy, we studied short-term results and adverse events

as secondary endpoints defined by patient reports, thus

avoiding any bias that may arise when health-care

personnel with technique preferences assess outcome

[11,12]. The results show that men were more likely to

seek health care within 3 mo after open surgery compared

to robot-assisted surgery. Reoperation during initial hospi-

tal stay was statistically significantly more frequent after

Table 5 – Comparison between open and robot-assisted surgery concerning patient-reported readmissions 3 mo after surgery a

Readmission andreadmission causes

Open surgery, b

n (%)Robot-assisted

surgery, c

n (%)

Unadjusted RR(CI 95%)

Unadjusted OR(CI 95%)

Adjusted fornontumour

confounders d,e

OR (CI 95%)

Adjusted forA + tumour-specific

confounders f

OR (CI 95%)

Adjusted forA + B + lymph

node dissection g

OR (CI 95%)

Readmission 57 (7.7) 163 (9.3) 1.21 (0.91–1.62)

1.23 (0.90–1.69) 1.26 (0.89–1.78) 1.21 (0.83–1.77) 1.39 (0.94–2.06)

Infection 10 (1.3) 37 (2.0) 1.56 (0.78–3.12)

1.57 (0.78–3.17) 1.61 (0.75–3.43) 1.44 (0.64–3.21) 1.68 (0.73–3.85)

UTI 7 (0.9) 21 (1.1) – – – –

Deep infections 2 (0.3) 7 (0.4) – – – –

Sepsis 0 (0.0) 7 (0.4) – – – –

Wound infection 1 (0.1) 2 (0.1) – – – –

Cardiovascular 9 (1.2) 5 (0.3) 0.23 (0.08–0.70)

0.23 (0.08–0.69) 0.32 (0.09–1.16) 0.28 (0.07–1.09) 0.32 (0.08–1.27)

Pulmonary embolism 5 (0.6) 3 (0.2) – – – –

DVT 2 (0.3) 0 (0.0) – – – –

Chest pain 1 (0.1) 1 (0.1) – – – –

AMI 1 (0.1) 1 (0.1) – – – –

Surgical 15 (1.9) 55 (3.0) 1.54 (0.88–2.72)

1.56 (0.88–2.78) 1.54 (0.82–2.87) 1.48 (0.75–2.92) 1.77 (0.87–3.60)

Catheter blockage and

retention after catheter

removal

7 (0.9) 19 (1.0) – – – –

Anastomotic leakage 1 (0.1) 14 (0.8) – – – –

Bleeding 1 (0.1) 9 (0.5) – – – –

Lymphocele 4 (0.5) 3 (0.2) – – – –

Abdominal pain 2 (0.3) 10 (0.5) – – – –

Miscellaneous 4 (0.5) 25 (1.4) 2.63 (0.92–7.54)

2.66 (0.92–7.65) 2.34 (0.78–6.99) 1.63 (0.54–4.96) 1.44 (0.47–4.45)

Operation hernia 0 (0.0) 4 (0.2) – – – –

Other likely related to

procedure

1 (0.1) 13 (0.7) – – – –

Other not likely related

to procedure

2 (0.3) 6 (0.3) – – – –

Psychological 1 (0.1) 2 (0.1) – – – –

Readmission leading to

reoperation

13 (1.7) 29 (1.6) 0.94 (0.49–1.80)

0.94 (0.49–1.82) 1.07 (0.54–2.13) 1.22 (0.54–2.73) 1.44 (0.62–2.34)

Readmission not leading

to reoperation

36 (4.6) 116 (6.3) 1.36 (0.94–1.95)

1.38 (0.94–2.03) 1.45 (0.95–2.22) 1.34 (0.85–2.11) 1.56 (0.97–2.50)

OR = odds ratio; RR = relative risk; CI = confidence interval.a Total may not add up to 100 due to rounding of percentages.b Denotes retropubic radical prostatectomy.c Denotes robot-assisted laparoscopic radical prostatectomy.d Possible confounders to be used in adjustments for each outcome were selected as variables significantly associated ( p value < 0.20) with the specific

outcome.e Adjustment A. Infection adjusted for: age at surgery, employment status preoperatively, physical exercise, previously operated for inguinal hernia, previous

transurethral resection of the prostate (TURP), International Prostate Symptom Score (IPSS), cardiovascular disease, mental disorder, kidney disease, and

prostate weight. Cardiovascular adjusted for: IPSS, pulmonary disease, neurologic disease, and prostate weight. Surgical adjusted for: age at surgery,

employment status preoperatively, coronary bypass surgery, IPSS, mental disorder, and prostate weight. Miscellaneous adjusted for: age at surgery,

postoperative irradiation, previously operated for inguinal hernia, IPSS, kidney disease, and prostate weight. Readmission leading to reoperation adjusted for:

age at surgery, postoperative irradiation, and prostate weight. Readmission not leading to reoperation adjusted for: employment status preoperatively,

previously operated for inguinal hernia, previous TURP, IPSS, mental disorder, and prostate weight.f Adjustment B: Adjustment A + tumour factors (preoperative prostate-specific antigen level, clinical tumour stage, tumour stage of prostatectomy specimen,

Gleason score on biopsy cores, and Gleason score pathology on specimen).g Adjustment C: Adjustment A + B + lymph node dissection.

E U R O P E A N U R O L O G Y 6 7 ( 2 0 1 5 ) 6 6 0 – 6 7 0666

open surgery when adjusting for tumour factors and

lymph node dissection. The robot-assisted technique also

improved short-term outcomes such as perioperative

bleeding and length of hospital stay, but resulted in

longer operating time compared to open surgery. Howev-

er, there was no statistically significant difference in

readmittance rate between the groups within 3 mo after

the operation.

It was more common to seek health care after open

surgery compared to robot-assisted surgery. The data

specifically show that it was more common to seek health

care for cardiovascular reasons in the open group. The

difference was statistically significant after adjusting for

nontumour and tumour-specific confounders. Patient-

reported outcomes showed higher absolute percentages

of thromboembolic events, deep venous thrombosis and

pulmonary embolism in the open radical prostatectomy

group compared to the robot-assisted surgery group

(Table 4). Similar results have been presented by van

Hemelrijck et al [13] in a large retrospective case-control

[(Fig._1)TD$FIG]

(n = 4003)

No informed consent (n = 21)

Robot-assisted laparoscopic radical prostatectomy (n = 1847)

Evaluable (n = 2625)

Reported to the study register Start date: September 1, 2008 End date: November 7, 2011

>75 yr ≥20 ng/ml prostate-specific antigen (PSA) >T3 tumor stage Metastatic disease

Withdrawn consent; not understanding Swedish; physical, psychosocial and practical reasons (n = 281)

Open radical prostatectomy (n = 778)

Surgeon having performed <100 operations (n = 980) No cancer in surgical specimen (n = 2) No operation performed (n = 26)

Analysed (n = 745)

Preoperative clinical report form 98%

Surgical clinical report form 98%

Postoperative care clinical report form 98%

6–12-wk clinical report form 98%

Preoperative patient questionnaire 89%

3-mo patient questionnaire 96%

Analysed (n = 1761)

Response rates

Preoperative clinical report form 100%

Surgical clinical report form 100%

Postoperative care clinical report form 100%

6–12-week clinical report form 99%

Preoperative patient questionnaire 88%

3-mo patient questionnaire 96%

Fig. 1 – Flow chart for the analysis of short-term results of the LAPPRO trial. Numbers may not total correctly, because the same individual may havefulfilled more than one exclusion criteria.

E U R O P E A N U R O L O G Y 6 7 ( 2 0 1 5 ) 6 6 0 – 6 7 0 667

study. A theory for the reason for more thromboembolic

events in the open group is that the extraperitoneal

approach leaves a smaller space than the robot-assisted

approach if haematomas or lymphoceles occur, and this

could result in high pressure on the femoral veins and lead

to deep venous thrombosis, which also is a common cause of

pulmonary embolism. However, Gandaglia et al [14] recently

reported in a study of 5915 men that patients treated with

open and robot-assisted techniques had similar risk of overall

postoperative complications, and that robot-assisted surgery

led to a higher risk of genitourinary and miscellaneous

medical complications.

Patients operated on by open surgery reported some-

what more contact with the health-care system for

gastrointestinal symptoms compared to those operated

on by robot-assisted surgery, although this was not

statistically significantly different (Table 4). Most trials

of laparoscopic versus open abdominal surgery have found

that gastrointestinal symptoms (ie, nausea, impaired

appetite, or changes in stools) occur for a longer period

of time after open surgery [15,16]. However, Schroeck et al

[17] reported no difference concerning bowel function

between a robot-assisted laparoscopic group and an open

retropubic radical prostatectomy group. Results also show

E U R O P E A N U R O L O G Y 6 7 ( 2 0 1 5 ) 6 6 0 – 6 7 0668

that more men sought care due to psychological symptoms

after open surgery compared to the robot-assisted ap-

proach (Table 4). In Sweden and the USA, men have an

increased risk of suicide in the year after a prostate cancer

diagnosis [18–20]. Men with newly diagnosed prostate

cancer seek psychiatric health care more often than cancer-

free men [21]. Our study, finding a difference in the

prevalence of psychological symptoms between surgical

techniques, indicates that predictors other than the

existential challenge of the cancer diagnosis need to be

explored in relation to psychiatric morbidity among

prostate cancer patients.

Reoperation during hospital stay was significantly more

frequent after open surgery compared to robot-assisted

surgery when adjusting for tumour factors and lymph node

dissection (Table 3). Similarly, in a meta-analysis by Tewari

et al [1], reoperation rates were significantly higher in the

open surgery group compared to the robot-assisted surgery

group; however, after propensity adjustments, there was no

significant difference. The reduced risk for reoperation with

the robot-assisted technique might be explained by less

tissue trauma and/or less perioperative bleeding, which has

previously been shown in other types of surgery to lead to a

lower degree of inflammatory response [22].

As others have previously shown, our results indicate that

robot-assisted laparoscopic radical prostatectomy seems to

be advantageous over open surgery in terms of perioperative

bleeding and length of hospital stay (Table 3). These results

are similar to data in a newly conducted meta-analysis and in

a registry-based study [1,23,24]. The reason for less bleeding

in the robot-assisted technique is usually explained by the

pneumoperitoneum, which gives a high pressure in the

abdomen during surgery and minimises perioperative

bleeding. The positioning of the patient in the Trendelen-

bourg position, which reduces venous blood pressure, is

another explanation which may have a positive effect on

perioperative bleeding. The shorter operating time associat-

ed with the open technique, as reported in this study, was

also confirmed by other authors [25,26].

There was no statistically significant difference in the

overall readmission rate within 3 mo after surgery; however,

the overall readmission rate was slightly more common after

robot-assisted surgery compared to open surgery (9.3% vs

7.7%; Table 5). These data confirm the report of Gandaglia

et al [14], who reported in 2014 that patients undergoing

open and robot-assisted surgery had similar odds of

readmission within 90 d after surgery. Although there was

no statistically significant difference between the groups

concerning causes for patient-reported readmissions in our

study, the data show that it was more common to be

readmitted for cardiovascular reasons after open surgery, but

this significance disappeared after adjustments. In a national

registry-based study, Chung et al [27] found higher rates of

readmission after open retropubic radical prostatectomy

compared to the robot-assisted approach.

The strengths of our study include the prospective,

controlled design, size, short inclusion period, high

response rate, use of validated measures, and the neutral

third-party approach. We made sure to obtain accurate

information of known and suspected risk factors for

adjustment. The modest changes after adjustments indi-

cate that the residual confounding is small, if any. Since

health-care professionals in the respective centres were

not blinded, either as assessors or as reporters of surgery-

induced problems, the reports could be influenced by their

enthusiasm for the surgical technique used in their centre.

The ‘‘I want to please my surgeon’’ attitude among

patients, on the other hand, is possibly related more to

the surgeon than the surgical technique [28,29]. A

limitation of the study, apart from the nonrandomised

design, is the lack of a standardised tool for the assessment

of the adverse events. At the time when the study was

designed and initiated, the Clavien-Dindo system of

systematic grading of adverse events after surgical

procedures, which requires data on the management of

the complications, was not generally recognised and,

therefore, was not included in the clinical report forms

[30]. Another limitation is the lack of a standardised

postoperative clinical pathway in the study. Each of the

14 centres used their own best practice, and this might

influence the hospital stay data.

5. Conclusions

Our study shows that short-term outcomes may be

influenced by the surgical technique used for radical

prostatectomy. However, evaluating the pros and cons of

robot-assisted laparoscopic radical prostatectomy as com-

pared with open surgery involves weighing together a large

number of incommensurable short- and long-term out-

comes, including economic consequences and cure rates.

Author contributions: Anna Wallerstedt had full access to all the data in the

study and takes responsibility for the integrity of the data and the accuracy

of the data analysis.

Study concept and design: Wallerstedt, Tyritzis, Carlsson, Hugosson,

Bjartell, Wilderang, Wiklund, Steineck, Haglind.

Acquisition of data: Wallerstedt, Tyritzis, Thorsteinsdottir, Carlsson,

Stranne, Gustafsson, Hugosson, Bjartell, Wilderang, Wiklund, Steineck,

Haglind.

Analysis and interpretation of data: Wallerstedt, Tyritzis, Thorsteinsdottir,

Carlsson, Stranne, Gustafsson, Hugosson, Bjartell, Wilderang, Wiklund,

Steineck, Haglind

Drafting of the manuscript: Wallerstedt, Hugosson, Bjartell, Wiklund,

Steineck, Haglind.

Critical revision of the manuscript for important intellectual content:

Wallerstedt, Tyritzis, Thorsteinsdottir, Carlsson, Stranne, Gustafsson,

Hugosson, Bjartell, Wilderang, Wiklund, Steineck, Haglind.

Statistical analysis: Wallerstedt, Wilderang

Obtaining funding: Wiklund, Steineck, Haglind

Administrative, technical, or material support: Wiklund, Steineck, Haglind.

Supervision: Wiklund, Steineck, Haglind.

Other (specify): None.

Financial disclosures: Anna Wallerstedt certifies that all conflicts of

interest, including specific financial interests and relationships and

affiliations relevant to the subject matter or materials discussed in the

manuscript (eg, employment/affiliation, grants or funding, consultan-

cies, honoraria, stock ownership or options, expert testimony, royalties,

or patents filed, received, or pending), are the following: None.

E U R O P E A N U R O L O G Y 6 7 ( 2 0 1 5 ) 6 6 0 – 6 7 0 669

Funding/Support and role of the sponsor: None.

Acknowledgment statement: The HRQL study was supported by research

grants from the Swedish Cancer Foundation (2010/593), Region Vastra

Gotaland, Sahlgrenska University Hospital (ALF grants 138751 and

146201, agreement concerning research and education of doctors),

Swedish Research Council, Mrs. Mary von Sydow Foundation, Anna and

Edvin Berger foundation, and EUSP fellowship grant to Dr. Stavros I.

Tyritzis. We thank Dr. Sven Grundtman for including patients.

Appendix A. Members of the LAPPRO steering

committee

Bo Anderberg, Department of Surgery, St Gorans Hospi-

tal, Stockholm, Sweden; Ingela Bjorholt, Nordic Health

Economics, Goteborg, Sweden; Thomas Jiborn, Department

of Urology, Skane University Hospital, Lund University,

Lund, Sweden; Jan-Erik Damber, Department of Urology,

Institute of Clinical Sciences, Sahlgrenska Academy at the

University of Gothenburg, Goteborg, Sweden; Ali Khatami,

Department of Urology, Institute of Clinical Sciences,

Sahlgrenska Academy at the University of Gothenburg,

Goteborg, Sweden; Mikael Wulkner-Sylme, Department of

Urology, Varberg Hospital, Varberg, Sweden; Christer

Edlund, Department of Surgery, Kungsbacka Hospital,

Kungsbacka, Sweden; Erik Pileblad, Capio Lundby Hospital,

Gothenburg, Sweden; Hans Boman, Department of Surgery,

Alingsas Hospital, Alingsas, Sweden; Ola Bratt, Department

of Urology, Helsingborg Hospital, Helsingborg, Sweden;

Ulrika Westlund, Department of Urology, Sodersjukhuset,

Stockholm, Sweden

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