Post-Radical Prostatectomy Inguinal Hernia: A Simple SurgicalIntervention can Substantially Reduce the Incidence—ResultsFrom a Prospective Randomized Trial

Johan Stranne,* Gunnar Aus, Svante Bergdahl, Jan-Erik Damber, Jonas Hugosson,Ali Khatami and Pär LoddingFrom the Department of Urology, Sahlgrenska University Hospital, Göteborg, Sweden

Abbreviations

and Acronyms

IH � inguinal hernia

PLND � pelvic lymph nodedissection

RRP � radical retropubicprostatectomy

Submitted for publication December 9, 2009.Study received local ethics committee ap-

proval.* Correspondence: Department of Urology, Sahl-

grenska University Hospital, 413 45 Göteborg, Swe-den (telephone: �46-31-3429007; FAX: �46-31-821740; e-mail: johan.stranne@vgregion.se).

Purpose: After radical retropubic prostatectomy a postoperative inguinal herniadevelops in 15% to 20% of patients. We investigated whether a simple prophy-lactic procedure during radical retropubic prostatectomy would reduce this inci-dence.Materials and Methods: A total of 294 consecutive patients scheduled for radicalretropubic prostatectomy at our clinic were prospectively included in the study.Patients with a present inguinal hernia or a previous inguinal hernia surgerywere not included in the analysis. The subjects were randomized for side ofprophylactic intervention (left or right). At radical retropubic prostatectomy anonresorbable figure-of-8 suture was placed lateral to the internal ring of theinguinal canal and the spermatic cord on either side according to outcome of therandomization. Patients were followed at regular followup visits at the clinic. Atthe end of the study all patients were invited for a final interview and examina-tion by an independent examiner who was unaware of the side of intervention.Results: Of the patients 86% (254) showed up for the final examination. Thecumulative inguinal hernia incidence was 3.5% on the intervention side and 9.1%on the control side (log rank Mantel-Cox p � 0.011). There were no seriousadverse events, and no increase in postoperative discomfort in the groin andtesticular region on the intervention side. The procedure added 5 to 10 minutesto the duration of surgery.Conclusions: The prophylactic procedure was simple and safe to perform, and itdecreased the risk of postoperative inguinal hernia formation by 62%. We believeit should be considered for patients undergoing radical retropubic prostatectomy.

Key Words: prostatectomy; prostatic neoplasms; hernia, inguinal; prevention

and control

984 www.jurology.com

INGUINAL hernia is a clinically impor-tant complication of radical retropu-bic prostatectomy, occurring in 15% to20% of patients within 3 years.1–6 Amajority of postoperative IHs are lat-eral or indirect, meaning they pro-trude through a defect in the region ofthe internal ring of the inguinal canallateral to the inferior epigastric ves-

sels.2,4 It is likely that the lower mid-

0022-5347/10/1843-0984/0THE JOURNAL OF UROLOGY®

© 2010 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION AND RES

line incision used during RRP affectsthe integrity of the internal ring andits shutter mechanism and, thereby,is of causative importance for the de-velopment of postoperative IHs.5–9 Inthis prospectively randomized studywe investigated whether a prophylac-tic surgical narrowing of the internalring of the inguinal canal during RRP

could decrease post-RRP IH forma-

Vol. 184, 984-989, September 2010Printed in U.S.A.

EARCH, INC. DOI:10.1016/j.juro.2010.04.067

SURGERY FOR INGUINAL HERNIA AFTER RADICAL RETROPUBIC PROSTATECTOMY 985

tion in patients without a history of IH surgery orclinically overt IH.

MATERIALS AND METHODS

Patients eligible for inclusion in this study were menscheduled to undergo RRP at Sahlgrenska UniversityHospital. Patients with a history of lower abdominal sur-gery, excluding appendectomy, and those with previousIH repair or a clinical IH on preoperative clinical exami-nation were not eligible for study. A clinical hernia wasdefined as an IH detectable on physical groin examinationbefore RRP regardless of patient awareness of the hernia.

All RRP procedures were essentially performed usingthe technique of anatomical RRP described by Walsh.10

All patients underwent simultaneous PLND restricted tothe obturator fossa bilaterally. A prophylactic procedurewas added on the right or the left groin. The procedurewas a simplified version of the method of lateral IH repairduring RRP described by Schlegel and Walsh.11 The sper-matic cord was mobilized and the area of the internal ringof the inguinal canal was identified. The internal ring wasfreed of excess fatty tissue. The spermatic cord was re-tracted medially, and a nonresorbable 2-zero figure-of-8suture was placed between the transversus arch and theiliopubic tract lateral to the spermatic cord, narrowing theopening of the internal ring (fig. 1). According to the pro-tocol the same standardized procedure was performed re-

Figure 1. Illustration of prophylactic procedure. A, left spermaticplaced between transversus arch and iliopubic tract lateral to sp

11

incision. Reprinted with permission.

gardless of the appearance of the internal ring. The pa-tients were randomized for intervention side by the year ofbirth, ie the left side if the patient was born in an oddnumbered year (1943, 1945 etc) and the right side if thepatient was born in an even numbered year (1942, 1944etc). The patients were not informed of the randomizationalgorithm or of the intervention side. By this study designeach patient formed his own control.

A pre-study 80% power calculation estimated a need toinclude 300 patients to detect a decrease in IH incidence of50% (10% to 5%) between the intervention and controlside. During the recruitment period of approximately 2.5years (August 2003 to March 2006) 432 patients met theinclusion criteria and were offered participation in thestudy. An informed consent was obtained from 354 pa-tients who constituted the study group. Of these patients60 did not receive a prophylactic suture due to technicaldifficulties during RRP in 12 and due to omission by theurologist or unknown reasons in 48. Thus, a prophylacticprocedure was performed according to the study protocolin 294 patients (fig. 2).

The duration of surgery and the amount of blood losswere recorded. During followup the patients were exam-ined at regular postoperative visits. In May and June 2008all patients were invited for an end of study interview andphysical groin examination by a physician not previouslyassociated with the project, who was unaware of the ran-domization algorithm and the side of intervention. At this

is retracted medially and nonresorbable 2-zero double suture isic cord. B, internal ring of inguinal canal is narrowed. C, line of

cordermat

SURGERY FOR INGUINAL HERNIA AFTER RADICAL RETROPUBIC PROSTATECTOMY986

evaluation the patients were physically examined in thegroin in a standing position including a Valsalva maneu-ver and were interviewed about any surgical proceduresfor IH at any time after the RRP as well as about discom-fort in the groin area. The patients described the nature ofany discomfort in their own words. A total of 254 patients(86%) attended the final examination, 127 of whom hadthe prophylactic procedure performed on the right sideand 127 on the left. The final results are based on thesepatients (fig. 2).

We assessed the cumulative IH incidence for the inter-vention side over time compared to the control side usingKaplan-Meier survival analysis and Kaplan-Meier plots.The difference between the sides was analyzed using thelog rank (Mantel-Cox) test. The influence of potential riskfactors for IH development was assessed using univariateCox regression. The study was approved by the local ethicscommittee.

RESULTS

Inguinal hernia developed in 28 patients during fol-lowup. Of these hernias 5 occurred on the interven-tion side, 19 were on the control side and 4 werebilateral. The total estimated cumulative incidenceof IH after 36 months on Kaplan-Meier survivalanalysis was 12.6%, ie 3.5% on the intervention sideand 9.1% on the control side. The postoperative IHreduction on the intervention vs the control side was62% (log rank Mantel-Cox p � 0.011) (fig. 3).

Figure 2. Inclusion algorithm of study, and reasons for dropoutat RRP and at followup visit. 1, previous inguinal hernia surgeryin 105 patients, clinical IH in 43 and complicating comorbidity,eg previous kidney transplantation, urinary diversion or rectalamputation, in 5. 2, technical difficulties during RRP in 12 pa-tients, other reasons in 48. 3, 9 patients deceased, 6 moved and

25 no-show at followup visit.

Mean followup was 38.4 months (median 37.7,range 27.4 to 56.0). Mean, median and range of age,body mass index, duration of surgery and blood lossare shown in table 1. None of these factors influ-enced the risk of IH development.

Intraoperative complications consisted of 2 casesof external iliac vein puncture by the needle whenthe suture was placed and 1 case of bleeding fromthe plexus pampiniformis around the spermaticcord. The first 2 cases were managed with the ap-plication of a monofilament 6-zero vascular sutureover the puncture in the iliac vessel wall and thethird case was managed with ligation of some of theveins in the plexus. Bleeding was minimal and noneof these patients presented with any further postop-erative complications or discomfort.

Discomfort at any time postoperatively, usually ofa slight degree, was expressed on direct questioningby 30 patients at the end of study evaluation and/orat regular followup visits. The rate and nature ofpostoperative discomfort from the groin and testic-ular region are summarized in table 2. The prophy-lactic procedure on 1 side added approximately 5 to10 minutes to the duration of the RRP procedure.

Patients at risk: 244254 237 210 115 42

Intervention side

Control side

Log Rank (Mantel Cox) p=0.011

Cumulative risk of post-RRP inguinal hernia development

Time (months)

Figure 3. Kaplan-Meier estimated cumulative risk of post-RRPinguinal hernia.

Table 1

Mean Median (range) p Value 95% CI

Age 62.9 62.8 (43.0–73.4) 0.919 0.933–1.080Body mass index

(kg/m2)26.1 25.4 (19.8–40.6) 0.102 0.672–1.037

Duration of surgery(mins)

130 130 (68–209) 0.230 0.977–1.006

Blood loss (ml) 1,073 900 (100–4,500) 0.915 0.999–1.001

Statistics refer to IH development according to each investigated factor in a

univariate Cox proportional hazards test.

SURGERY FOR INGUINAL HERNIA AFTER RADICAL RETROPUBIC PROSTATECTOMY 987

DISCUSSION

Our results show that a prophylactic narrowing ofthe internal ring of the inguinal canal decreases thepost-RRP IH incidence on the intervention side by62% (p � 0.011). Furthermore, the addition of thenarrowing suture was feasible and safe. Inguinalhernias develop in approximately 15% to 20% ofpatients after undergoing RRP.1–6 When consider-ing the addition of a prophylactic surgical maneu-ver to prevent this problem it is essential that themethod is safe, efficient and easy to perform. Ourresults show that the prophylactic procedure wedescribe has few, if any, complications periopera-tively and it did not lead to late complications(table 2).

The method we used is a simplification of a pre-viously well described method for the repair of lat-eral IHs during RRP.11 This method of repair leavesonly the suture as foreign material in the surgicalarea. To understand why the simplified version ofthe method is efficient it is important to consider thelikely mechanism of post-RRP IH formation. Asmentioned previously a majority of the post-RRPIHs are indirect.2,4 A patent processus vaginalis hashistorically been considered mandatory for indirectIH formation and has a prevalence of approximately20%.12,13 However, this notion has been challengedand the cause of indirect herniation is likely multi-factorial.14 Defects of the supportive tissues of theshutter mechanism, by incrimination of the action ofthe lateral abdominal muscles by denervation15 orby defects in the connective tissues of the fasciaelayers,16 probably contribute to this type of hernia-tion as well.

Koie et al suggest that the length of the incision isof importance for IH development.8 They reported apostoperative IH incidence as high as 38.7% afterconventional RRP but only 2.9% in a group of 272patients in whom the procedure was performedthrough a so-called mini-laparotomy incision of only6 cm. Matsubara et al also reported an IH incidenceof 1.8% after radical perineal prostatectomy inwhich the whole procedure was performed through aperineal incision and consequently there was no ab-dominal incision at all.17 Thus, the incision itself as

Table 2. Postoperative discomfort

No. InterventionSide

No. ControlSide No. Bilat

Slight discomfort/prickling 7 5 10Small lump 1 2 0Severe discomfort/pain 0 1 2Infection (epididymitis) 1 0 0Lymphocele 0 1 0

Totals 9 9 12

well as the length of the abdominal incision seem to

affect the postoperative development of IH. We pre-viously demonstrated that IH development is also afrequent complication after other types of urologicalsurgery in men such as cystectomy, open surgery forbenign prostatic enlargement and PLND.6,9 Thus,the common denominator for postoperative IHseems to be the lower midline incision.

The incision may cause the IH by a disruption ofthe anatomical-physiological balance between thedifferent fascia layers of the abdominal wall, therebyimpairing the shutter mechanism of the inguinalcanal.3 By narrowing the internal ring of the ingui-nal canal as we have done in this study this balanceis not restored. However, we believe that the nar-rowing suture and the subsequent scar tissue for-mation in the area prevents the bowel from protrud-ing through the ring in most cases, despite thedefective shutter mechanism, thereby preventing in-direct IH formation.

Fujii et al recently described a significant reduc-tion of post-RRP IH by opening the funicle, andidentifying and transecting the processus vaginalis/peritoneal residue found inside.18 The outcome,when compared to a historical control group, sug-gests a good prophylactic effect, and scar tissue for-mation around the internal ring is likely important,especially in cases in which no processus vaginaliswas found. Results from a small study by Sakai et al,in which mere blunt dissection and isolation of thespermatic cord during RRP reduced the incidence ofIH, further suggest that scar tissue formation isimportant.19 The preventive effect at the internalring of our chosen method is not absolute, as dem-onstrated by the occurrence of a few postoperativeIHs on the intervention side in our study, but it isstill remarkably efficient.

The method of surgery in the present study wasstandardized and all patients underwent simulta-neous PLND. Although PLND has previously beenshown not to add to the incidence of post-RRP IHformation when performed during RRP, we consid-ered it important that the various steps of the oper-ation be simple and identical in all patients.20 Thisincluded the technique for applying the prophylacticsuture. Therefore, no distinction was made in theprotocol between patients with a normal internalring, a patent processus vaginalis or a small subclin-ical IH at surgery. The prevalence of subclinicallesions, depending on the method of detection,21 isreported to be between 13% and 33%.9,22–24 It isplausible that such lesions will be prone to developinto clinically symptomatic IHs if the negative im-pact of a lower midline incision, for instance duringRRP, is added. In view of our results some patientswith subclinical IHs have probably been protectedfrom clinical IH formation in 1 of their groins by

performance of the prophylactic procedure. Regret-

SURGERY FOR INGUINAL HERNIA AFTER RADICAL RETROPUBIC PROSTATECTOMY988

tably the presence of subclinical IHs was not specif-ically recorded during our study so no firm conclu-sions can be drawn on the effectiveness of theprocedure in the repair of subclinical defects.

When studying the effect of prophylactic surgicalmeasures during RRP to reduce post-RRP IH, sev-eral issues need to be addressed. It is important tostudy a group of patients that is as homogenous aspossible in terms of relevant preoperative risk fac-tors and the method in which the surgery was per-formed. This homogeneity ensures that any differ-ence in outcome can actually be attributed to theintervention performed rather than other factors.By randomizing the side of the prophylactic inter-vention we were able to minimize the influence ofunrelated factors and each patient could serve as hisown control regarding hernia development in eachgroin.

We also limited our study group to patients whowere without past or present IH morbidity. Patientswho underwent previous IH surgery or those with aprevalent unilateral IH have a post-RRP IH inci-dence of 18% to 30%.5,20,22,25 These IHs are predom-inantly on the contralateral side of the previouslesion.20 Thus, the inclusion of such patients in thisstudy would jeopardize the study interpretationsince the groins would be at different risks for her-nia and, furthermore, would obviously be unsuitableto act as their own controls. Therefore, it is impor-tant to note that the total cumulative incidence ofpost-RRP IH demonstrated in the present study ofselected patients (12.6% at 36 months) should not becompared to that of other studies, which usuallyreport higher incidence figures.1–6 Due to the studydesign with patients being their own controls wehave no control group for duration of surgery and

blood loss.

REFERENCES

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What effects can be anticipated if this prophylac-tic procedure were also to be used on patients withIH morbidity in the form of previous surgery orpresent hernia? In fact, it is likely that such patientswould especially benefit from a prophylactic proce-dure on the previously not operated side becausethis side has an increased risk of post-RRPIH.2,5,20,22,25 We believe that in patients who presentwith a hernia that is large enough to be detected atclinical examination, regardless of whether it issymptomatic, a regular hernia repair should be per-formed. Various methods to perform this repair dur-ing RRP have been discussed by several au-thors.11,26,27

IH causes discomfort for patients, is potentiallydangerous, and is costly for the individual and forsociety. A 62% reduction in post-RRP IH incidencewould lead to a reduction within 3 years from ap-proximately 15% to 20%, to 6% to 8%.1–6 Consider-ing the high number of radical prostatectomies per-formed the prophylactic method has the potential tobe beneficial in a large number of patients. Theimpact might be even greater if the prophylaxiswere to be used on male patients also undergoingother surgical procedures involving the use of alower midline incision. Preoperative identificationand adequate repair of prevalent IH will likely re-duce the incidence further.

CONCLUSIONS

A prophylactic narrowing of the internal ring of theinguinal canal with a lateral suture reduced the riskof post-RRP IH formation by 62% in the selectedgroup of patients without preoperative IH morbid-ity. This method is easy and safe, causes few if anycomplications and, therefore, should be considered

for these patients.

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