Randomized clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia

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1 Randomized clinical trial Randomized clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia D. Arvidsson 1,F.H.Berndsen 9, L. G. Larsson 2, C.-E. Leijonmarck 3,G.Rimbäck 4,C.Rudberg 5, S. Smedberg 6,L.Spangen 7 and A. Montgomery 8 Departments of Surgery, 1 Karolinska Hospital, Stockholm, 2Örebro University Hospital, Örebro, 3 St Göran s Hospital, Stockholm, 4 Frölunda Specialist Hospital, Frölunda, 5 Västerås Hospital, Västerås, 6 Helsingborg Hospital, Helsingborg, 7 Central Hospital, Karlstad, and 8 Malmö University Hospital, Malmö, Sweden, and 9 Akranes Hospital, Akranes, Iceland Correspondence to: Dr F. H. Berndsen, Department of Surgery, Akranes Hospital, 300 Akranes, Iceland ( fritz.berndsen@simnet.is) Background: The Shouldice technique is the gold standard of open non-mesh hernia repair. The aim of this study was to compare 5-year recurrence rates after Shouldice and laparoscopic transabdominal preperitoneal patch (TAPP) repair for primary inguinal hernia. Method: Men with a primary unilateral inguinal hernia were randomized to either Shouldice or TAPP operation. An independent observer scored the surgeons performance. Follow-up comprised clinical examination after 1 year, a questionnaire after 2 and 3 years, and a clinical examination after 5 years. Results: Between February 1993 and March 1996, 1183 patients were included. Nine hundred and twenty patients were followed for 5 years, 454 in the TAPP group and 466 in the Shouldice group. Recurrences were evenly distributed between groups throughout the follow-up period. The cumulative recurrence rate after 5 years was 6 6 per cent in the TAPP group and 6 7 per cent in the Shouldice group. Postoperative pain was a risk factor for recurrence after Shouldice operation but not after TAPP repair. There was a correlation between a low surgeon s performance score and recurrence. Conclusion: The 5-year recurrence rate is acceptable, with no difference between TAPP and Shouldice repair. Poor operative performance resulted in a higher recurrence rate. The TAPP operation represents an excellent alternative for primary inguinal hernia repair. Paper accepted 29 May 2005 Published online in Wiley InterScience ( DOI: /bjs.5137 Introduction Inguinal hernia surgery has changed dramatically over the past 10 years. The introduction of various open mesh 1 5 and laparoscopic 6 8 techniques has increased the interest in inguinal hernia surgery among general surgeons. Ever since Edoardo Bassini 9 marked the beginning of modern inguinal hernia surgery, the main aim has been to lower the recurrence rate, but per cent of all inguinal hernia operations are for recurrent hernia The Shouldice technique was considered to be the gold standard at the start of the 1990s 11 and recurrence rates as low as 1 4 per cent after 4 12-year follow-up have been The Editors have satisfied themselves that all authors have contributed significantly to this publication achieved However, there is a long learning curve and results from single surgeons and centres of excellence have not been reproduced in a wider setting Laparoscopic inguinal hernia repairs have already proven to have excellent short-term results, with less postoperative pain and shorter convalescence and sick leave compared with open techniques 21 24, but at the cost of a longer operating time and increased hospital costs However, there are few large randomized studies comparing long-term outcome 29. The Swedish Multicenter trial of Inguinal hernia repair by Laparoscopy (SMIL) study group, a group of Swedish surgeons with a special interest in laparoscopy and inguinal hernia surgery, was formed in 1993 to conduct studies in this field. The aim of the present study was to compare 5-year recurrence Copyright 2005 British Journal of Surgery Society Ltd British Journal of Surgery 2005; 92:

2 1086 D. Arvidsson, F. H. Berndsen, L. G. Larsson, C.-E. Leijonmarck, G. Rimbäck, C. Rudberg, S. Smedberg, L. Spangen and A. Montgomery rates after laparoscopic transabdominal preperitoneal patch (TAPP) repair and modified Shouldice repair for primary inguinal hernia. Patients and methods Seven surgical centres in Sweden participated in the study. Men aged years with a primary unilateral inguinal hernia were eligible for inclusion. Exclusion criteria were American Society of Anesthesiologists (ASA) grade IV and V, scrotal hernia, previous major abdominal surgery, language difficulties and mental disturbance. After giving written informed consent, patients were randomized in computer-generated blocks of 20 and stratified for each centre using numbered closed envelopes. The local ethics committees approved the trial. Twenty-five board-certified surgeons performed the operations, 12 in the TAPP group and 13 in the Shouldice group. Before the trial the surgeons underwent training in the operative techniques. Each surgeon performed at least 25 operations within the trial. The standard operative procedures have been described in detail in a previous paper that reported short-term outcome 30. In the TAPP operation the peritoneum was opened above the internal ring and the preperitoneal space was entered. After dissection of the hernia sac and preparation of Cooper s ligament and the triangle of doom (which consists of vas deferens medially, the spermatica vessels laterally and the iliac vessels at the bottom), a 7 12 cm polypropylene mesh (Prolene ; Ethicon, Somerville, New Jersey, USA) was inserted and stapled in place using an endoscopic stapler (EMS Multifeed Staplegun; Ethicon). Care was taken not to use staples below the iliopupic tract. The peritoneum was stapled in place to cover the mesh completely. A modified three-layer Shouldice repair was performed. After the transection of the cremaster muscle, dissection and resection of an indirect hernia sac, the transversalis fascia was opened from the internal ring to the pubic tubercle and the femoral canal inspected. In the case of direct hernias, attenuated transversalis fascia was resected. A three-layer repair was performed using a running 2/0 polypropylene suture. No prophylactic antibiotics were given in either group. An independent observer randomly reviewed videorecorded operations performed by surgeons in the TAPP group and evaluated the surgical performance in the Shouldice group by visiting participating centres and assisting at operations. Points were given for specific aspects of each operation and summed to give a total score ranging from 0 to 9. For TAPP operations, points were given for exploration of Cooper s ligament (1 point), exploration of the triangle of doom (2 points), medial placement of mesh (2 points), lateral placement of mesh (2 points) and adherence to protocol (2 points). Shouldice operations were scored as follows: dissection and preparation of tissues (2 points), exploration of nerves, femoral fossa and peritoneal reflexion at the internal ring (2 points), performance of the repair (3 points) and adherence to the protocol (2 points). Follow-up included clinical examination after 1 year, a questionnaire at 2 and 3 years, and a clinical examination after 5 years. Patients were asked in the questionnaire whether they had a bulge in the operated groin and/or discomfort. Patients with complaints were examined clinically. Recurrence was defined as a bulge in the operated groin when standing and straining. Herniography was performed if the examination was inconclusive. Only patients who completed 5-year follow-up or who developed recurrence during the study period were included in the final analysis. Variables analysed as potential risk factors for recurrence were ASA grade, age, smoking habit, occupation, hernia size (visible versus palpable only), Nyhus classification 43, operating time, complications at 1 week, pain the first week after operation (combined visual analogue scale (VAS) score on days 1, 2, 3, 5 and 7 days), duration of sick leave, complaints at 3 months follow-up, hospitals and surgeons. Statistical analysis Assuming that the recurrence rate would be 5 per cent higher in the TAPP group, it was calculated that 1115 patients would be needed to detect such a difference with a power of 90 per cent and 5 per cent significance. Continuous variables were calculated as mean(s.d.) and compared using two-tailed Student s t test. Ordinal variables were calculated as median (range) and compared using Mann Whitney U test. Pearson s χ 2 square test was used to compare frequencies. Statistical evaluations were performed using SPSS version 11.0 (SPSS, Chicago, Illinois, USA). Differences in recurrence rate between the operative methods and the impact of independent variables on recurrence (risk factors) were evaluated using the NL mixed model in SAS 8.2 statistical program (SAS Institute, Cary, North Carolina, USA). Spearman s correlation coefficient was used to evaluate the correlation between surgeon s performance score and recurrence rate. P < was considered statistically significant.

3 Recurrence after primary inguinal hernia repair 1087 Results Between February 1993 and March 1996, 1183 men with primary inguinal hernias were randomized. One hundred and fifteen patients were excluded before surgery for various reasons (Fig. 1). A total of 1068 patients were included and 920 patients (86 1 per cent) completed the 5-year follow up 454 in the TAPP group and 466 in the Shouldice group. There were no differences in patient demographics between the groups (Table 1). Median (range) follow-up was 61 (58 96) months in the TAPP group and 61 (57 83) months in the Shouldice group. The cumulative recurrence rate at 5 years was 6 6 per cent (30 patients) in the TAPP group and 6 7 per cent (31 patients) in the Shouldice group (P = 0 978) (Fig. 2). The predicted recurrence rate, calculated using the NL mixed model, was 5 7 (95 per cent confidence interval (c.i.) 3 0 to10 5) per cent in the TAPP group and 6 8 (95 per cent c.i. 4 1 to11 2) per cent in the Shouldice group; the relative risk was therefore 1 2 (95 per cent c.i. 0 4 to1 8). Recurrences were evenly distributed between the two groups throughout the study period (Fig. 2). ASA grade, age, smoking, occupation, hernia size, Nyhus classification, operating time, complications, sick leave and complaints at 3 months were evaluated in a mixed model Table 1 Patient demographics TAPP (n = 454) Shouldice (n = 466) Age (years)* 51 2(10 5) 52 2(10 7) Weight (kg)* 78 7(11 1) 78 7(9 5) Height (cm)* 178 1(8 2) 178 4(7 4) Smoker 102(22 5) 97(20 8) Chronic obstructive lung disease 13(2 9) 18(3 9) Steroid medication 12(2 6) 10(2 1) Occupation Light physical work 184(40 5) 176(37 8) Moderate physical work 100(22 0) 86(18 5) Heavy physical work 95(20 9) 118(25 3) Unoccupied 14(3 1) 21(4 5) Retired 55(12 1) 59(12 7) Sick leave because of hernia (days) ASA grade I 403(88 8) 417(89 5) II 47(10 4) 42(9 0) III 2(0 4) 3(0 6) Unknown 2(0 4) 4(0 9) Size of hernia Visible 349(76 9) 353(75 8) Palpable only 103(22 7) 108(23 2) Values in parentheses are percentages unless indicated otherwise; *Values are mean (s.d.). TAPP, transabdominal preperitoneal patch, ASA, American Society of Anesthesiologists. Consent to randomization 1183 Assigned to TAPP 597 Assigned to Shouldice 586 Drop-outs before operation Randomization error 36 Patient refused operation 15 Patient had moved 2 Emergency operation 4 Other reasons 10 Drop-outs before operation Randomization error 22 Patient refused operation 14 Patient had moved 3 Emergency operation 1 Other reasons 8 Patients operated 530 Patients operated 538 Did not attend follow-up at 1 year 10 2 year 3 3 year 11 5 year 52 Did not attend follow-up at 1 year 4 2 year 6 3 year 4 5 year 58 5-year follow-up year follow-up 466 Fig. 1 Study flow chart. TAPP, transabdominal preperitoneal patch

4 1088 D. Arvidsson, F. H. Berndsen, L. G. Larsson, C.-E. Leijonmarck, G. Rimbäck, C. Rudberg, S. Smedberg, L. Spangen and A. Montgomery Recurrence rate (%) TAPP Shouldice 1 year 2 years 3 years 5 years Follow-up Fig. 2 Cumulative recurrence rate. TAPP, transabdominal preperitoneal patch and none of these factors was identified as a risk factor for recurrence. Patients who had severe pain in the first week after Shouldice repair (combined VAS index greater than 200 mm) had a higher risk of recurrence than those with a lower combined index (P = 0 006) (Table 2). Severe postoperative pain was not a risk factor in the TAPP group (P = 0 573). There was no significant difference in recurrence rate between hospitals or individual surgeons but there was a great variance. The recurrence rate at different hospitals ranged from 5 to 13 per cent in the TAPP group and from 2 to 14 per cent in the Shouldice group. That for individual surgeons ranged from 0 to 23 and from 0 to 19 per cent respectively. The independent observer evaluated 12 of 13 surgeons who performed the modified Shouldice repair and ten of 12 who did TAPP repairs. The median (range) surgeon s performance score was 8 (6 9) and 9 (5 9) respectively. There was a significant correlation between surgeon s performance score and 5-year recurrence rate (r s = 0 520; P = 0 019). When calculated with a mixed model, the risk for recurrence was 0 72 times increase per 1 point decrease in score (95 per cent c.i to 0 94). According to this model the increased risk for recurrence between surgeons with score 6 and 9 was 2 6 times(95percentc.i.2 1 to3 2). Of the 61 patients with recurrence (TAPP 30, Shouldice 31), 40 patients were either reoperated or had a positive herniogram (TAPP 19, Shouldice 21). In the TAPP group nine patients had an indirect and ten a direct recurrence, compared with one and 20 patients respectively in the Shouldice group (P = 0 002) (Table 3). Discussion In this randomized multicentre trial there was no difference in the 5-year recurrence rate after laparoscopic TAPP and Shouldice repairs. Some 86 1 per cent of all operated patients were examined clinically at 5 years, which is acceptable considering the long follow-up. In the only other study that compared long-term outcome after laparoscopic versus open repair, 719 (72 3 per cent) of 994 operated patients were followed up at either 3 or 5 years 29. Laparoscopy has still not found a place in the field of inguinal hernia repair. Many authors recommend laparoscopic techniques in the treatment of bilateral and recurrent hernias after anterior operations, particularly if mesh has been used 26, In 1995, 16 per cent of inguinal hernia operations registered in the Swedish Hernia Register were laparoscopic repairs, but by 2000 this had Table 3 Type of recurrent hernia Type of recurrence Primary n Direct Indirect TAPP repair II* IIIa IIIb Unknown Shouldice repair II* IIIa IIIb Unknown Classified according to Nyhus: *indirect hernia with enlarged internal ring; direct inguinal hernia; indirect hernia causing posterior wall weakness. TAPP, transabdominal preperitoneal patch. Table 2 Postoperative pain the first week in relation to recurrence rate TAPP (n = 388)* Shouldice (n = 394)* Combined VAS score (mm) Recurrence No recurrence P* Recurrence No recurrence P > TAPP, transabdominal preperitoneal patch; VAS, visual analogue scale. *66 patients in the TAPP group and 72 patients in the Shouldice group did not complete a postoperative pain diary. SAS NL mixed model.

5 Recurrence after primary inguinal hernia repair 1089 decreased to 10 per cent 10. The fact that many surgeons started using this new technique at the start of the 1990s, but then abandoned it owing to its technical complexity and long learning curve 34, might explain this decrease. In contrast, laparoscopic techniques are increasingly being used in Germany; they currently comprise 30 per cent of all inguinal hernia operations and specialized laparoscopic hernia centres have been established 35. Many studies have shown that laparoscopic hernia repair produces better short-term results than open techniques, such as less postoperative pain and shorter convalescence 23,36,37, but few large studies have compared long-term results. A Cochrane meta-analysis of 41 randomized trials reported a lower recurrence rate after laparoscopic compared with open non-mesh repair, but there was no difference in recurrence rate after laparoscopic versus open mesh repair 38. The median follow-up in these studies ranged from 6 weeks to 3 years. On the other hand, Neumayer et al. 39 noted a higher recurrence rate after laparoscopic hernia repair (10 1 per cent) compared with open mesh repair (4 9 per cent) at 2-year followup in a large randomized trial of 2164 patients. The recurrence rate in the laparoscopic group was particularly high considering the short follow-up. The mesh size was not reported. The recurrence rate at 2 years in the present study was 5 1 per cent in the laparoscopic group and 4 3 per cent in the open group. The recurrence rate of 6 6 per cent after 5 years in the TAPP group is acceptable but possibly higher than expected. This might partly reflect the long follow-up, but may be a consequence of use of a small mesh (7 12 cm), which was recommended when the study was initiated. The small mesh might explain the indirect recurrences in the TAPP group. Polypropylene mesh shrinks up to 40 per cent 40, emphasizing the need for a large mesh to achieve good coverage of the inguinal area. Liem et al. 29 reported a recurrence rate of 4 9 per cent after totally extraperitoneal laparoscopic (TEP) repair and 10 per cent after open repair at 4-year follow-up in a randomized study, and suggested that recurrences develop early after laparoscopic repair, whereas the recurrence rate after open repair increases with time. The present results do not confirm this as recurrences were evenly distributed in both groups throughout the study period. The recurrence rate in the Shouldice group (6 7 per cent) is comparable to rates in non-specialized centres 19,28,41,42. All operations were performed by surgeons with a special interest in hernia surgery but not hernia specialists. Beets et al. 20 reported a 5-year recurrence rate after Shouldice repair of about 6 per cent, increasing progressively to 15 per cent after 14 years. Severe pain in the first week after surgery was identified as a risk factor for recurrence after Shouldice but not after TAPP repair. This might be related to excessive tension in the suture line resulting in weakness or rupture of the repair. Twenty of 21 recurrences after Shouldice repair were shown be direct at reoperation, which further supports this theory. A surgical performance score, which considered specific aspects of the surgical procedure and was assessed by an independent observer, was used objectively to assess the surgical performance. The inverse correlation between performance score and recurrence rate indicates that recurrence is at least partly due to technical failure. Neumayer et al. 39 reported a higher recurrence rate (more than 10 per cent) among surgeons who had previously performed fewer than 250 laparoscopic operations compared with surgeons with more experience (less than 5 per cent). This reflects the long learning curve and complexity of the laparoscopic technique. With a 5-year recurrence rate similar to that of the Shouldice operation, TAPP repair represents an excellent alternative for repair of primary inguinal hernia. Acknowledgements Financial support was provided by Ethicon EndoSurgery, Johnson & Johnson Company, and Stig and Ragna Gorthon Foundation. Ethicon did not have any involvement in the design and conduct of the study or the data analysis. The following surgeons also participated in the study: J. Ahlberg, L. Blomgren and I. Svedberg (St Görans sjukshus, Stockholm), P. Almqvist, M. Bergenfeldt and U. Petersson (Universitetssjukhuset MAS, Malmö), J. Antonsson, E. Lundgren and I. Rasmussen (Akademiska Sjukhuset, Uppsala), L. G. Ekman, O. Thorén and U. Wingren (Mölndals sjukhus), L.-K. Enander (Centralsjukhuset Karlstad), A. Hellberg and B. Sjögren (Centrallasarettet Västerås), E. Jörtsö, G. Wickbom and G. Ågren (Regionsjukhuset Örebro). 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