Comprehensive preoperative evaluation and repair of inguinal hernias at the time of open radical retropubic prostatectomy decreases risk of developing post-prostatectomy hernia
Herbert Lepor, Department of Urology, NYU School of Medicine, 150 East 32nd Street – 2nd Floor, New York, NY 10016, USA. e-mail: firstname.lastname@example.org
Study Type – Therapy (case series)
Level of Evidence 4
What's known on the subject? and What does the study add?
Some studies have evaluated preoperative and intraoperative examination for inguinal hernias and their repair, noting a decrease in the rate of post-prostatectomy hernias. However, this did not eradicate post-prostatectomy hernias, indicating that this method probably missed subclinical hernias. Other studies looked at prophylactic procedures to prevent the formation of inguinal hernias at the time of prostatectomy and showed a decrease in the rate of postoperative hernias.
To our knowledge this is the only series evaluating a multi-modal approach with magnetic resonance imaging, ultrasonography and examination to identify all clinical and subclinical hernias and repair them at the time of prostatectomy. This approach only subjects those patients at risk for symptomatic hernias to an additional procedure and decreases the post-prostatectomy hernia rate to <1%.
- • To assess if a comprehensive evaluation to diagnose clinical and subclinical hernias and repair of these hernias at the time of open radical retropubic prostatectomy (ORRP) decreases the incidence of clinical inguinal hernias (IHs) after ORRP.
PATIENTS AND METHODS
- • Between 1 July 2007 and 31 July 2010, 281 consecutive men underwent ORRP by a single surgeon.
- • Of these men, 207 (74%) underwent comprehensive preoperative screening for IH, which included physical examination, upstanding ultrasonography and magnetic resonance imaging.
- • Between 12 and 24 months after ORRP, 178 (86%) of these men completed a questionnaire designed to capture development of clinical IHs.
- • Of the 178 evaluable patients, 92 (52%) were diagnosed preoperatively with IH by at least one diagnostic modality.
- • Forty-one and 51 of the men had bilateral or unilateral IHs, respectively for a total of 133 IHs.
- • No preoperative factor was significantly associated with the presence of an IH before prostatectomy.
- • No groin subjected to IH repair (IHR) at the time of ORRP developed a clinical IH compared with four of the 21 patients with postoperative IHs who did not undergo repair of their preoperatively diagnosed IH at the time of ORRP (P= 0.024).
- • Only one (0.4%) clinical IH developed in a groin that had no evidence of IH by physical examination, upstanding ultrasonography and magnetic resonance imaging before prostatectomy.
- • Our comprehensive evaluation increases the detection of IHs before ORRP.
- • Repair of these IHs at the time of ORRP significantly decreases the risk of developing post-prostatectomy clinical IHs.
open radical retropubic prostatectomy
The observation that inguinal hernias (IHs) develop in 8.6–23.9% of men undergoing open radical retropubic prostatectomy (ORRP) led to speculation that this surgical procedure caused his [1–8]. Epidemiological studies have shown that the prevalence of IHs in men between the ages of 45 and 74 years is between 28 and 40% . This high rate of IHs in the general male population suggests that IHs exist before ORRP and become symptomatic after surgery.
We previously reported our initial experience using physical examination (PE) to identify IHs that were subsequently repaired at the time of ORRP . Of 1130 men undergoing preoperative inguinal PE, IHs were identified in 143 (13%). All of these IHs were repaired at the time of ORRP using a preperitoneal approach [10,11]. Despite efforts to preoperatively diagnose and repair all IHs, 67 of the 795 (8.4%) men without evidence of preoperative IH developed an IH after prostatectomy . These IHs were either undetected on preoperative evaluation or were caused by ORRP.
Nielson and Walsh  observed that 33% of men had evidence of IHs based on an intraoperative examination of the inguinal ring and inguinal floor at the time of ORRP. Despite the fact that all of these IHs were repaired, the postoperative IH rate was 5.3%, suggesting that intraoperative examination fails to identify all IHs or in selected cases, ORRP causes IHs. Intraoperative examination is limited as the patient is supine, cannot perform a Valsalva manoeuvre and the diagnosis of IH is entirely subjective.
Recently, we examined the sensitivity of several diagnostic modalities including PE, upstanding ultrasonography (USUS), and Valsalva MRI for the detection of IHs before ORRP . The sensitivity of PE, USUS and Valsalva MRI was 37.5%, 69.4% and 51.4% respectively. When combining two modalities the sensitivity improved to 89.5% for PE and vMRI, 90.0% for PE and USUS, and 95.8% for USUS and Valsalva MRI.
The objective of this study was to evaluate whether a comprehensive preoperative evaluation for IHs consisting of PE, USUS and MRI and subsequent repair of these IHs at the time of ORRP further decreases the risk of developing clinical IHs after surgery.
PATIENTS AND METHODS
Between 1 July 2007 and 31 July 2010, 281 consecutive men with localized prostate cancer underwent ORRP by a single surgeon. Institutional review board approval was obtained to extract clinical information from our Institutional review board-approved Longitudinal Prospective Outcomes Radical Prostatectomy Database, which captures information about the patient, the disease and clinical outcomes. The database prospectively records findings on preoperative inguinal PE, USUS and MRI and responses to the following questions related to development of clinical IHs at scheduled follow-up evaluations: ‘Have you experienced a bulge in your groin?’ and ‘Have you had a hernia repair?’.
Two hundred and seven (74%) of the consecutive cohort of ORRP underwent a comprehensive evaluation for IH consisting of PE, USUS and MRI before ORRP. These patients were included in the study. The PE was performed by the surgeon who also performed all the ORRPs. Both inguinal canals were palpated in the upstanding position during a Valsalva manoeuvre. Ultrasonography of the bilateral inguinal canals was carried out as the patient was performing a Valsalva manoeuvre while in the upstanding position and was interpreted by a single experienced radiologist using a Sequoia ultrasound machine and a 10-MHz linear transducer. An MRI of the inguinal canals was performed in the supine position at rest and during a Valsalva manoeuvre during a prostate MRI examination as previously described . In less than 5% of cases the prostate MRI was performed at another institution without Valsalva. One patient underwent CT in addition to the comprehensive inguinal evaluation and was noted to have an IH that was not detected on PE, USUS or MRI. This IH was also repaired at the time of ORRP.
The IHs were repaired at the time of ORRP using a preperitoneal approach [10,11]. Of the 207 men evaluated for IH, 178 (86%) completed a self-administered questionnaire between 12 and 24 months after ORRP, which captured whether they developed a clinical IH (bulge in the groin or underwent an IHR) post-prostatectomy.
The exact Mann–Whitney test and the Fisher exact test were used to compare evaluable and non-evaluable men with respect to numeric and categorical baseline characteristics, respectively. Binary logistic regression and Fisher exact test were used to assess whether numeric and categorical factors, respectively, were predictive of IH before prostatectomy. The chi-squared test was used to compare the incidence of IH after ORRP among men who were preoperatively diagnosed with an IH and underwent IHR; those who were preoperatively diagnosed with IH and refused IHR; and those who had no evidence of IH preoperatively. All reported P values are two-sided and statistical significance is defined as P < 0.05. SAS 9.3 (SAS Institute, Cary, NC, USA) was used for all statistical computations.
The baseline characteristics for the total cohort and the evaluable men are shown in Table 1. There were no significant differences between these two groups.
Table 1. Baseline characteristics
|Number of patients||103||178|| |
|Age||60.42 ± 7.17||60.02 ± 7.55||0.630a|
|Body mass index||27.26 ± 4.73||27.03 ± 4.72||0.211a|
|Prostate-specific antigen||7.41 ± 7.52||5.00 ± 3.31||0.003a|
|Preoperative AUASS||6.32 ± 5.97||6.26 ± 5.74||0.999a|
|Prostate volume||53.86 ± 87.83||57.15 ± 73.12||0.777a|
|Race (% non-Caucasian)||15.5||9.0||0.119b|
|History of IHR (% Yes)||26.3||19.2||0.215b|
|Clinical stage (%T2/T3)||31.6||27.8||0.580b|
|Pathological stage (% pT3/pT4)||35.0||32.6||0.696b|
|Gleason score (%)|| || ||0.548b|
| 6||48.5||46.3|| |
| 7||37.9||43.3|| |
| 8 or more||13.6||10.1|| |
Overall, 264, 248 and 248 men underwent PE, USUS and MRI of the inguinal canals, respectively, with the intent of diagnosing clinical and subclinical IHs. A total of 207 of the 281 men underwent all three investigations. Of these men, 178 completed a postoperative assessment regarding development of IHs between 12 and 24 months after ORRP. Of the 356 comprehensive inguinal examinations performed before ORRP, 133 (37%) groins exhibited an IH. Of the 133 total IHs detected, PE, USUS and MRI detected 34 (25.6%), 89 (66.9%) and 77 (57.9%), respectively. The incidence of left, right and bilateral IHs was 22, 29 and 41, respectively. No baseline factor was predictive of the diagnosis of IH before prostatectomy (Table 2).
Table 2. Factors predicting inguinal hernia before prostatectomy
|% with preoperative hernia|
|Clinical stage|| ||0.510b|
| 8 or greater||50.0|
|Pathological stage|| ||0.057b|
|Prior IHR|| || |
|Constipation|| || |
One hundred and twelve of the 133 (84%) IHs diagnosed before ORRP were repaired at the time of ORRP. The incidence of developing a recurrent IH within the first 2 years postoperatively was 0% (Table 3). Of the 21 IHs diagnosed prior to ORRP that were not repaired because of patient preference, four developed clinical IHs postoperatively. Interestingly, three of these four IHs were not evident on preoperative PE. Of the 223 groins found to be negative for IH by PE, USUS and MRI, only one (0.4%) developed a clinical IH after ORRP. All five patients with postoperative IH underwent an inguinal hernia repair by a general surgeon. Four of these five patients also reported a bulge on the questionnaire. The likelihood of developing clinical IHs after ORRP was significantly higher when an IH was not repaired at the time of ORRP compared with the group whose hernias were repaired at the time of surgery (P= 0.024) (Table 3). The number of men who developed clinical IHs after ORRP was also significantly higher in men who did not undergo IHR at the time of ORRP compared with those men who did not have evidence of IH before surgery (P= 0.028) (Table 3).
Table 3. Preoperative and postoperative inguinal hernias in men undergoing open radical retropubic prostatectomy
|Yes|| || || |
| Repaired||112||0 (0)||112 (100)|
| Not repaired||21||4 (19)||17 (81)|
|No||223||1 (0.4)||222 (99.6)|
Inguinal hernias occur in up to 23.9% of men undergoing ORRP [1–8]. In all the ORRP series reporting high rates of post-prostatectomy IHs, no effort was made to preoperatively diagnose IHs and repair the defect at the time of surgery. Therefore, it was unclear whether the ORRP caused the IHs or simply transformed subclinical hernias into clinical hernias. A strategy to preoperatively identify those men at risk for developing clinical IHs and subsequent repair of the IHs at the time of ORRP would obviate the need for a second surgical procedure to repair the IH.
Schlegel and Walsh reported a simple preperitoneal technique for repairing IHs that were diagnosed by PE at the time of ORRP through the lower midline incision . Despite efforts to diagnose and repair these IHs, 5.3% of men who underwent IHR developed new clinical IHs postoperatively at a different site from their IHR at the time of ORRP .
We have reported a similar experience. Overall, 46 IHs were diagnosed by preoperative PE and most were repaired at the time of ORRP. Post-prostatectomy IHs developed in 67 (8.4%) of the groins that on PE showed no evidence of an IH. It was unclear whether the IHs occurring after ORRP in the Nielsen and Walsh  and Lepor and Robbins  series were directly caused by the ORRP or whether the surgical procedure had simply transformed subclinical IHs into clinical IHs.
We have shown that subclinical IHs can be detected using US or MRI if special protocols are used . One disadvantage of MRI is that it is performed in the supine position, which is not optimal for detecting IHs. We have shown that the sensitivity of MRI for detecting IHs is improved when the imaging is performed during a Valsalva manoeuvre . The advantage of US is that it can be performed both in the standing position and during a Valsalva manoeuvre. Although we reported that USUS is the most sensitive single test for identifying IHs, maximal preoperative IH detection is performed when a comprehensive inguinal assessment includes PE, USUS and MRI with Valsalva. In the study by Marien et al. , PE alone failed to preoperatively detect 62.5% of IHs. This led us to postulate that these subclinical IHs identified by imaging were probably the IHs that were occurring post-prostatectomy despite efforts to repair those IHs identified by PE.
In the present study, 33% of groins harboured an IH after a comprehensive examination for preoperative IHs. In those groins with no evidence of preoperative IH after a comprehensive evaluation, it was exceedingly rare (<1%) that an IH developed post-prostatectomy. Our results provide the rationale for a comprehensive evaluation that involves preoperative inguinal imaging in addition to PE. The present study also provides compelling evidence that ORRP does not cause IHs but rather transforms some subclinical IHs into clinical IHs.
In the present study, we assessed whether a comprehensive evaluation for IHs before ORRP and repair of these IHs at the time of surgery decreased the risk of developing clinical IHs after prostatectomy. The IHRs were only performed on those patients with an IH diagnosed by PE or an imaging modality. Of the 112 hernias that were repaired at the time of ORRP, no patient developed a recurrent clinical IH (Table 3). Of the 21 patients who did not undergo repair of an IH at the time of ORRP, 19% developed clinical IHs after surgery (Table 3) (P= 0.024). Repairing all IHs after a comprehensive evaluation versus only PE significantly reduces post-prostatectomy clinical IHs.
Another strategy to decrease the incidence of post-prostatectomy IHs has been to examine the inguinal ring and floor intraoperatively and perform IHR if a hernia is present. Using this strategy, Nielsen and Walsh subjected 33% of patients to an IHR . Despite this high rate of IHR, IHs developed in the contralateral groin or in a different area in the ipsilateral groin (i.e. an indirect where a direct IHR was performed and vice versa) in 5.3% of cases. No results were given on the occurrence of IH in the 288 patients who did not undergo IHR at the time of ORRP. The development of a post-prostatectomy IH was determined on routine follow-up .
Investigators from Japan have recently recommended performing prophylactic procedures at the time of ORRP on all men undergoing ORRP to prevent the development of post-prostatectomy IHs . Fujii et al.  advocate ligating and transecting the processus vaginalis close to the peritoneal cavity. Of 569 consecutive ORRP, this procedure was performed in 138 cases. The post-prostatectomy IH rate was 24% in patients who did not undergo the prophylactic procedure compared with 1% in the group of men who underwent the prophylactic procedure (P < 0.001) . This procedure on average was performed in 10 min and was associated with no postoperative complications. The development of IH in this cohort was assessed by asking the patients at the outpatient clinic on routine follow-up if they had developed a new IH.
Another group from Japan retrospectively evaluated releasing the bilateral spermatic cords from the peritoneum before wound closure as well as manually freeing at least 5 cm of peritoneum from the abdominal wall to prevent bowel from herniating through the internal inguinal ring after prostatectomy . Of the 101 patients who underwent the prophylactic procedure, no patient had developed an IH at approximately 1 year of follow up. Of the 170 patients who did not undergo the prophylactic procedure, 11.8% had developed IHs at approximately 2 years of follow-up . This procedure reportedly added only a few minutes to the operative time. It is unclear how postoperative hernias were assessed in this series.
Stranne et al.  evaluated the effectiveness of placing a figure-of-8 permanent suture lateral to the internal ring at the time of ORRP in a prospective, randomized and single-blinded study. The procedure was performed unilaterally with the contralateral side serving as the control. Overall, IHs developed on the intervention and control sides in 3.5% and 9.1%, respectively (P= 0.011). The procedure increased operative time by 5–10 min. There was no increase in postoperative groin or testicular pain . Postoperative IH was determined by a groin examination performed by a physician not directly associated with the study.
All of the above studies report a significant decrease in the development of IHs in the groups undergoing prophylactic intervention with a short increase in operative time. There are several issues with this approach. In the control groups, IHs occurred in less than 25% of cases. Therefore, over 75% of men would need to undergo an unnecessary procedure to prevent post-prostatectomy IH. In addition, these surgical techniques address only the inguinal ring and therefore would effectively manage only indirect IHs. As most IHs in this age group are direct IHs, one would expect a significant recurrence rate.
Multi-parametric MRI of the prostate is being used more often as a way to determine the location of prostate cancer and staging. In cases where MRI is routinely performed, the inclusion of a few sequences of the groin under Valsalva adds minimal time or cost to the procedure. The USUS can be easily performed in the office setting. In our series, accurate detection of IHs using our comprehensive evaluation allowed us to perform IHR only on those patients with an IH. We feel that a comprehensive evaluation for IHs before ORRP and repair of those hernias at the time of surgery is the preferred approach to prevent the occurrence of post-prostatectomy IH because it obviates unnecessary procedures and allows for repair of the defect in the inguinal floor and not only the internal ring.
We also examined possible factors that are associated with the diagnosis of IH before prostatectomy. Recently Rabbani et al. showed in their cohort of 4592 patients that increasing age, decreasing body mass index, history of IHR, and the development of bladder neck contracture were associated with an increased risk of post-prostatectomy his . Others have shown conflicting evidence regarding history of IHR, lower body mass index, increasing age, and anastomotic stricture [2–5,18]. No baseline characteristics were associated with the risk of having an IH after our comprehensive evaluation prostatectomy in the present series (Table 2).
It is beyond the scope of this manuscript to conduct a comprehensive cost effectiveness analysis supporting our recommendation to perform a comprehensive preoperative assessment to detect and then repair IHs in all men undergoing ORRP. At our institution, Medicare reimburses $94 for a USUS. We routinely obtain a multiparametric MRI preoperatively to stage the disease and there is no additional cost for the inguinal series performed during a Valsalva manoeuvre. Therefore, imaging added $15 728 to the preoperative assessment of the 178 evaluable cases. Medicare payment to the surgeon for IH repair is $578. Of the 178 evaluable men, the surgeon reimbursement for the 133 IH repairs was $76 874. The preperitoneal IH repair is completed within 10 min and adds negligible additional cost to the procedure. The estimated Medicare payments for preoperative testing, anaesthesia, surgeon and the hospital per single case of an IHR as an independent outpatient are $250, $218, $578 and $2738, respectively. The total estimated Medicare payment for an outpatient IHR is $3784. If one assumes that 20% of men will develop postoperative IHs if no effort is made to identify clinical and subclinical IHs preoperatively, then 36 men would be expected to develop clinical IHs that require surgical repair. The estimated total costs for repairing the secondary IHs in our evaluable men would have been $136 224, which is almost double the Medicare payment for the comprehensive evaluation for IHs and their repair. The cost-effectiveness analysis does not account for the economic losses associated with the recovery from an additional surgical procedure.
The strengths of this study include that it is prospective, all PEs were performed by one surgeon and all USUS were performed by one ultrasonographer. Another strength of our study is the high percentage of men who completed the survey capturing post-prostatectomy IHs. This study is limited by the fact that not all MRIs were performed at the same centre or read by the same radiologist. Because of the high rate of IH after ORRP, we felt that randomizing men with IHs to repair versus no repair was not ethical. Therefore, we compared our rates of IH to our historical controls.
Another limitation of our study and the literature is the criteria for post-prostatectomy IH. Our criteria were limited to clinical IHs because they were based on development of a groin bulge or undergoing an IHR. It is possible that subclinical hernias may have developed post-prostatectomy because we did not perform inguinal imaging studies on any of the men after ORRP. We feel that subclinical, asymptomatic hernias after surgery are of no clinical significance unless they are prone to develop into symptomatic hernias. Whereas our experience suggests that clinical IHs occur within the first 2 years of ORRP, we continue to follow our patients so that we can eventually report longer-term outcomes.
In conclusion, a comprehensive evaluation for IHs before surgery and repair of these IHs at the time of ORRP significantly decreases the subsequent risk for developing a clinical hernia. Adding inguinal imaging to the PE reduces the rate of post-prostatectomy IHs from 8.4% to 0.3% if one removes the men with preoperative IHs who refused to under IHR. Our strategy to identify and repair all clinical and subclinical IHs to prevent development of clinical IHs is preferred to prophylactic procedures which would subject the overwhelming majority of men to an unnecessary procedure and without any attempt to repair the inguinal floor. Based on our findings, we recommend that men with localized prostate cancer undergoing ORRP should undergo a preoperative evaluation that includes an inguinal PE and at least one imaging study (USUS or Valsalva MRI) with repair of all the IHs at the time of ORRP.
CONFLICT OF INTEREST