Hernia (2007) 11:247252 DOI 10.

1007/s10029-007-0215-6

O R I G I N A L A R T I CL E

Inguinal hernia is a common complication in lower midline incision surgery

J. Stranne J. Hugosson P. Lodding

Received: 21 August 2006 / Accepted: 26 February 2007 / Published online: 4 April 2007 Springer-Verlag 2007

Abstract Inguinal hernia is a known complication after radical retropubic prostatectomy (RRP). We have investigated whether other types of lower midline incision surgery in males increase the risk of inguinal hernia. Male patients operated with open prostatectomy for benign prostate hyperplasia (n = 95), pelvic lymph node dissection for staging of prostate cancer (n = 88), or cystectomy for bladder cancer (n = 76) were identiWed and were sent questionnaires in which they were asked about postoperative inguinal hernia morbidity. Two-hundred and seventy-one men operated with RRP had previously received a similar questionnaire. The answers were compared with those from a control group of 953 men who had not undergone surgery. Annual attributional hernia morbidity and KaplanMeier hernia-free survival were calculated. The cumulative incidence of post-operative inguinal hernia and annual attributional hernia morbidity after the respective surgical procedures were clearly higher during the early years postoperation than for nonoperated patients. Inguinal hernia is a common postoperative complication in males after all the lower midline incision surgery investigated. Keywords Surgery Inguinal hernia Postoperative complication

complication in radical retropubic prostatectomy (RRP) [1]. Several studies have established that incidence is between 10 and 20% [28]. It has also been reported that pelvic lymph node dissection for staging in prostate cancer (PLND) seems to be associated with an increased risk of post-operative inguinal hernia development [3, 4]. Although the exact prevalence and incidence of inguinal hernia in the population are unknown, we recently established that the annual incidence of inguinal hernia in a group of men with stage M0 prostate cancer treated without surgical intervention was less than 0.5% [9]. Research has not yet identiWed any speciWc manoeuvres of the RRP procedure responsible for the increased risk of inguinal hernia development. Instead, it seems the lower midline incision itself may be the cause [8]. Other procedures using the same type of incision ought, therefore, to be associated with the same complication. Our hypothesis in this study was, therefore, that all surgical procedures performed through lower midline incisions in males increase the risk of postoperative inguinal hernia development.

Materials and methods Five diVerent groups of male patients were recruited from Sahlgrenska University Hospital. All 130 patients who underwent open prostatectomy for benign prostatic hyperplasia (OP) during 19942003 were identiWed in October 2005. Of these, 95 were still alive and received a self-administered questionnaire concerning hernia morbidity. Seventy-Wve patients (79%) responded, these constitute the OP group. All 118 patients with prostate cancer who underwent pelvic lymph node dissection (PLND) for the purpose of

Introduction Since the Wrst report by Regan and co-workers in 1996 it has become well established that inguinal hernia is a
J. Stranne (&) J. Hugosson P. Lodding Department of Urology, Sahlgrenska University Hospital, 413 45 Gteborg, Sweden e-mail: johan.stranne@vgregion.se

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Hernia (2007) 11:247252 Table 1 Mean, median, and range of total follow-up time and age at the beginning at follow-up for the Wve patient groups Procedure Total follow-up time in months mean (median; range) 69 (68; 23138) 70 (69; 28141) 66 (67; 23132) 25 (24; 336) 39 (42; 371) Age at surgery in years mean (median; range) 73 (73; 5487) 65 (66; 4774) 66 (67; 2686) 63 (64; 4374) 69 (79; 5387)

staging during the same period were identiWed. The 88 patients who were still alive received the same questionnaire. Seventy-one patients (81%) responded; these constitute the PLND group. All 184 male patients operated with cystectomy because of bladder cancer during the same period were identiWed. Of these, 76 men were still alive and received the same questionnaire. The 57 patients (75%) who responded constitute the cystectomy group. During 20012002, consecutive patients undergoing radical retropubic prostatectomy (RRP) (n = 271) were asked to complete a self-administered questionnaire concerning hernia morbidity both before surgery and 3, 6, 12, 24, and 36 months post-operation. A total of 207 men (74%) in this group answered the questionnaires; these constitute the RRP group. This material has previously been described in detail [8]. We have previously reported the incidence of inguinal hernia in a group of 953 stage M0 prostate cancer patients treated without surgery [9]; these constitute the control group. This material was gathered from the Scandinavian Prostate Cancer Group Study No. 6 (SPCG 6) [10]. The study primarily compared early bicalutamide monotherapy with placebo. All patients were seen every 12 weeks by an urologist and were asked whether any new medical conditions had developed since the last visit. Any new conditions were reported as adverse events in accordance with the protocol. All de-novo inguinal hernias reported in the study were identiWed from the database. These 953 men constitute the non-operated group in this study. In summary, three diVerent methods have been used to obtain data from Wve patients groups. A retrospectively administered questionnaire was used for the OP, cystectomy and PLND groups, a prospectively administered questionnaire was used for the RRP group, and a database search of prospectively gathered clinical information was conducted for the non-operated group. The mean, median, and range of follow-up duration and age at the beginning of follow-up for the respective groups are shown in Table 1. Follow-up duration was estimated from the date of surgery for the operated patients and from the date of inclusion in the SPCG 6 study for the non-operated group. In both the retrospective and the prospective questionnaires the patients were asked whether they had experienced a de-novo inguinal hernia after undergoing their respective urological surgery. The questions asked in the questionnaires were simple and straightforward requiring a yes, no, or dont know answer (Fig. 1). When patients expressed uncertainty about their inguinal hernia status or the onset of an inguinal hernia, before or after the urological procedure (n = 6), answers were treated as no. No conWrmation of the diagnosis of hernia by, for example, physical examination was obtained.

OP (n = 75) PLND (n = 71) Cystectomy (n = 57) RRP (n = 207) Non-operated (n = 953)

OP, open prostatectomy; PLND, pelvic lymph node dissection; RRP, radical retropubic prostatectomy

Kaplan-Meier analysis of inguinal hernia-free survival was performed to calculate cumulative incidence, including conWdence intervals, of post-operative inguinal hernia in the investigated groups, and a comparison was made in a Forest plot. The annual attributional morbidity for inguinal hernia was calculated, with hernia morbidity in the nonoperated group used to determine background morbidity. The excess inguinal hernia morbidity attributable to each consecutive post-operative year was calculated by subtracting the background morbidity from the inguinal hernia morbidity for each year for the respective groups. Statistical analysis was conducted with SAS 9.1.3 software (SAS Institute, Cary, NC, USA).

Results Cumulative inguinal hernia-free survival is shown in Fig. 2 and the attributional inguinal hernia morbidity for each consecutive year post-operation is shown in Fig. 3. The attributional morbidity is high during the Wrst 23 years but then drops to levels close to background morbidity. Cumulative incidence at 24 months, with conWdence intervals, for each of the surgical groups and for the non-operated group is shown in Fig. 4. Incidence of inguinal hernia in all the operated groups is clearly diVerent from that in the nonoperated group.

Discussion Just as for RRP, the other three surgical procedures performed through lower midline incisions also resulted in a substantial increase in the incidence of inguinal hernia formation during follow-up compared with the non-operated group. The consistency of our results indicates that the increased incidence is probably applicable to all lower midline incisions in males. As far as we are aware this has never been shown before.

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Hernia (2007) 11:247252 Fig. 1 English translation of retrospectively administered questionnaire for cystectomy patients

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Studies have addressed the overall incidence and prevalence of inguinal hernia in the population but the results have varied depending on the method of diagnosis. For example, hernias may be self-reported by the patients or detected during clinical examination by a physician. The latter method has a higher detection rate, because it also includes subclinical hernias [11]. In this study we used a non-validated retrospective patient-administered questionnaire for the OP, cystectomy, and PLND groups. The retrospective design and the occasionally long time between the surgical procedure and the questionnaire may give rise to recall bias regarding the onset of the inguinal hernia. The questions asked in the questionnaire were simple and straightforward, however, and all uncertain answers were treated as no. We therefore believe this questionnaire is

likely to slightly underestimate the incidence of inguinal hernia compared with physical examination. The response to the questionnaire of approximately 80% should be adequate for obtaining valid results. The results from the RRP group were obtained by using a similar, but prospectively administered, questionnaire [8]. The prospective design eliminates the risk of recall bias in this group and probably gives a more accurate estimate of post-operative incidence. Apart from this, however, the same limitations apply to this method of hernia detection as in the OP, cystectomy, and PLND groups. Bearing this in mind, we consider the results comparable. Because the true overall incidence of inguinal hernia in the population, let alone in this particular age-group of males, is virtually unknown [11], we chose to compare

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Hernia (2007) 11:247252

1.0

0.9

0.8

0.7

Non-operated control group OP PLND Cystectomy RRP

0.6

0 0 10 20 30 40 50 60 70

Time (months)
Fig. 2 Cumulative post-operative inguinal hernia-free survival for the investigated groups (OP open prostatectomy, PLND pelvic lymph node dissection, RRP radical retropubic prostatectomy)

incidence Wgures after surgery with those of 953 patients with stage M0 prostate cancer managed without surgery [9]. This material is, as far as we are aware, the only material from which the annual incidence of inguinal hernia in men in this age group can be estimated. Although these patients belong to a selected group with a speciWc disease, prostate cancer, we have no reason to suspect any inguinal hernia protective mechanisms in prostate cancer. On the contrary, a high prevalence of bladder outlet obstruction is likely in this patient group, because of their prostate disease

[12, 13], and this is a known risk factor for inguinal hernia development [14]. We believe these patients can be regarded a representative control group for inguinal hernia development which lends itself to comparison with the four groups of operated patients. DiVerent risk factors for post-RRP inguinal hernia development have been explored [7, 8] but no speciWc feature of the procedure seems to cause postoperative inguinal hernia formation. It has also been suggested that PLND and cystectomy cause postoperative inguinal hernia [3, 4], and a shorter incision has been shown to reduce the risk [6]. The idea that the lower midline incision itself causes inguinal hernia formation has therefore developed [6, 8]. Our results from this study, that all investigated procedures performed through lower midline incisions, although varying in most other aspects, for example duration, opening of the peritoneum, bowel resection, etc., are associated with an increase in postoperative cumulative inguinal hernia formation (Figs. 2, 4) further supports the theory that the incision itself is of causal importance. A possible explanation that has been suggested in discussion of post-RRP inguinal hernia formation is that the surgical procedure does not always cause a de-novo inguinal hernia but, instead, occasionally causes deterioration of a sub-clinical lesion already present. Several studies have shown a 1033% prevalence of incipient inguinal hernia in males [1416]. Previous inguinal hernia morbidity has also been shown to be a risk factor in post-RRP inguinal hernia development [7, 8]. The attributional inguinal hernia morbidity in our study is very high during the Wrst 23 years post-operation and then reaches background level (Fig. 3). Cumulative incidence of hernia is higher in all the operated groups than in the non-operated group throughout the entire

Attributional m orbidi ty (% )

Fig. 3 Annual attributional morbidity during follow-up after surgery. The non-operated group was used to determine background morbidity. The excess inguinal hernia morbidity attributable to surgery was calculated for each consecutive year postoperation by subtracting the background morbidity for each group (OP open prostatectomy, PLND pelvic lymph node dissection, RRP radical retropubic prostatectomy)

Cumulative inguinal hernia free survival

12 10 8 6 4 2 0 -2 0-12 -4 13-24 25-36 37-48 49-60

OP PLND Cy s tectomy RRP

Time intervals (months)

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OP PLND Cystectomy RRP Non-operated 0 5 10 15 20 25 30

Cumulative incidence in % at 24 months and 95% confidence intervals

Fig. 4 Forest plot showing the cumulative incidence of inguinal hernia, including 95% conWdence interval, 24 months post-operation after each surgical procedure or 24 months after inclusion in the SPCG-6 study for the non-operated group (OP open prostatectomy, PLND pelvic lymph node dissection, RRP radical retropubic prostatectomy)

follow-up period (Fig. 2). This indicates that even if the midline incision induces the development of a clinically signiWcant inguinal hernia from a pre-existing sub-clinical lesion, many of these lesions would have remained subclinical without the incision. Why has the problem of inguinal hernia development after lower midline incisions in males not been recognized previously? One reason is probably that inguinal hernia is such a common condition that its association with preceding surgery is not readily made. It was not until the 1990s, when the number of RRPs performed in the world increased rapidly, that a large group of patients subjected to a standardized lower midline incision surgical procedure was closely followed by the individual surgeon for a long period of time. This gradually led to awareness of an increased incidence of post-operative inguinal hernia after this procedure, Wrst described by Regan in 1996 [1]. As already stated, small studies on patients subjected to PLND and cystectomy have suggested an increased incidence of inguinal hernia in the former but not the latter [3, 4]. These studies, however, were performed by retrospective patient Wle review, a method we have recently shown to be sub-optimum for inguinal hernia detection after RRP [8]. Patients undergoing PLND before curative radiotherapy against prostate cancer are usually followed by an oncologist, rather than an urologist, and usually in a department diVerent from that in which the urologist performing the PLND resides. There are many well-known complications of radiotherapy, which the oncologist is on the look-out for [17], but inguinal hernia is not likely to be one of these. The development of such a lesion is therefore unlikely to be associated with the preceding surgical procedure.

Post-operative cystectomy patients, on the other hand, are monitored very closely by the operating urologist, because of their generally aggressive disease and the associated urinary diversion. The high post-operative mortality and morbidity [18], including manifestations of malignant disease and surgical complications, for example ventral and parastomal hernias, in this patient group are, however, likely to reduce the chance of a commonplace lesion such as an inguinal hernia being noticed and recorded in the patient Wle during the post-operation period. The probability of post-operative inguinal hernia being detected by use of a patient Wle survey would therefore be substantially lower than the true incidence in the population. OP patients usually make only one follow-up visit to the operating urologist for post-operation monitoring. There is, therefore, a high probability that development of post-operative inguinal hernia will not be revealed by a retrospective Wle survey of such patients, and urologists may be unaware of the magnitude of the problem. For these reasons it is understandable that inguinal hernia formation after these common urological procedures is an unrecognized problem, and one which may be undetected in a retrospective patient Wle survey. Addressing the question by using a standardized patient-administered questionnaire with direct questions about inguinal hernia has resulted in the emergence of a new picture. The mean and median follow-up times in this study were at least 29 months, allowing events to occur. This follow-up duration has been shown to be relevant in studies of post-RRP inguinal hernia [8]. There is great need for more studies focussing on the relationship between abdominal surgery and post-operative inguinal hernia and on prevention of the complication.

Conclusions Lower midline incision surgery performed in the male constitutes a signiWcant risk factor for subsequent development of inguinal hernia.
Acknowledgments To statistician Catrin Berqvist, PhD, for valuable contributions and supervision in planning and executing statistical data in the study. To the Swedish Cancer Society, Stockholm (grant no 4675-B05-05XAC), the Swedish Medical Association, Stockholm (grant no 2004-577), and the Gteborg Medical Association, Gteborg (grant no 04/205 and 05/4174) for Wnancial support.

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