A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias

The American Journal of Surgery 216 (2018) 78e83 Contents lists available at ScienceDirect The American Journal of Surgery journal homepage: www.ame...

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The American Journal of Surgery 216 (2018) 78e83

Contents lists available at ScienceDirect

The American Journal of Surgery journal homepage: www.americanjournalofsurgery.com

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias Benedetto Ielpo*, Hipolito Duran, Eduardo Diaz, Isabel Fabra, Riccardo Caruso, , Valentina Ferri, Sara Lazzaro, Denis Kalivaci, Yolanda Quijano, Emilio Vicente Luis Malave General Surgery Department, Sanchinarro Hospital, San Pablo University of Madrid, Spain

a r t i c l e i n f o

a b s t r a c t

Article history: Received 3 April 2017 Received in revised form 28 June 2017 Accepted 14 July 2017

Background: In literature, only a few studies have prospectively compared the results of laparoscopic with open inguinal hernia repair yet none have compared bilateral inguinal hernia repair. The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic transabdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia. Methods: Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters included hospital stay, operation time, postoperative complications, immediate postoperative pain and chronic pain, recurrence and quality of life. Results: Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-operative pain up to 7 days from surgery (p ¼ 0.003), a shorter length of hospital stay (p ¼ 0.001), less postoperative complications (p ¼ 0.012) and less chronic pain (0.04) when compared with the OLR approach. Conclusions: TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay and postoperative complications. © 2017 Elsevier Inc. All rights reserved.

Keywords: TAPP Lichtenstein Inguinal hernia

1. Introduction Inguinal hernia repair is one of the most widely performed surgical procedure.1 Amongst the techniques used, the open Lichtenstein repair (OLR) is still the most widely performed. However, in the last decade there has been an increased interest in the laparoscopic approach for inguinal hernia repair, mainly represented as the trans-abdominal pre-peritoneal (TAPP) technique.2e4 As described in recent studies, TAPP approach entails the benefits of minimally invasive surgery, such as less pain and early recovery.1 We expect that these benefits would be more apparent in the treatment of bilateral inguinal hernias given the fact that both hernias are repaired through a single unified access. However, there are not enough studies in literature to support the potential benefits of the TAPP approach4 in bilateral inguinal hernias and none address its impact on the quality of life compared

~ a 10, 28050, * Corresponding author. Sanchinarro University Hospital, Calle On Madrid, Spain. E-mail address: [email protected] (B. Ielpo). http://dx.doi.org/10.1016/j.amjsurg.2017.07.016 0002-9610/© 2017 Elsevier Inc. All rights reserved.

with OLR. The aim of this study is to confirm the hypothesis that TAPP procedure has superior outcome that OLR by comparing the results and the quality of life of patients who underwent TAPP versus OLR for the treatment of bilateral inguinal hernias.

2. Methods We prospectively included patients from the General Surgery Department at Sanchinarro University Hospital from 2013 to 2015. Inclusion criteria were patients older then 18 years of age, diagnosis of primary bilateral inguinal hernia assessed by ultrasound and in which any associated surgical procedure had not been performed. Mean follow up was 1 year. The main demographic preoperative data recorded were: age, gender, BMI, ASA score and size of hernia according to the EHS classification (Grade I: 1.5 cm, Grade II: 1.5e3 cm, Grade III: >3 cm).5 Exclusion criteria were contraindications for general anesthesia or laparoscopy, obstructed or strangulated inguinal hernias, hernia

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recurrences. Cases were randomized using a simple randomization with a computer program. All patients underwent the same anesthesia and post-operative analgesia protocol. A single dose of first generation cephalosporin was given at the induction of the anesthesia. Operative time was recorded at the end of each single procedure. 2.1. Surgical technique Both TAPP and OLR procedures were performed by senior consultant surgeons with a minimum of 2 years' experience in both TAPP and OLR in a standardized manner as follows: TAPP approach This procedure is performed under general anesthesia. The abdomen is insufflated with CO2 using a Veress needle in the left hypochondrium. Three trocars are placed in total. The 0grade optic is placed through a 10-mm diameter periumbilical incision. A 10-mm diameter trocar is placed in the right hypochondrium and finally, a 5-millimiter diameter trocar is placed symmetrically in the left hypochondrium (Fig. 1). The peritoneum is incised at the level of the trocar and extended medially in the direction of the superior margin of the internal inguinal ring up to the residue of the umbilical artery. The Cooper ligament is then exposed through a careful dissection of the preperitoneal parapubic adipose tissue. The hernia sac is than isolated and reduced freeing the spermatic cord. Finally, a polypropylene mesh (Prim) of almost 15  10 cm is placed bilaterally in the preperitoneal space as shown in the video 1 and it is partially cut for the spermatic cord. A metal staple is used to secure the mesh to the Cooper ligament (CapSure™, Bard). The peritoneal flap is than closed using 3 or 4 metal staples for each side.

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Supplementary video related to this article can be found at http://dx.doi.org/10.1016/j.amjsurg.2017.07.016. This procedure is performed using epidural anesthesia with the same antibiotic prophylaxis of the TAAP approach. OLR is performed by all surgeons according to the standard Lichtenstein open tension-free technique as described recently by Amid where ilioinguinal and iliohypogastric nerves are usually preserved.6 No local anesthetic was infiltrated. 2.2. Management after surgery All patients stay overnight. A standard analgesia regime was used equally for all patients postoperatively up to 7 days which includes paracetamol (1 gr) and metamizole (1 gr) every 8 h up to 24 h from surgery and then oral paracetamol (500 mgr) every 12 h. After discharge, patients are visited in the outpatient clinic at 7 days after surgery and then after 1, 2, 6 and 12 months from surgery. Chronic pain is defined if it is lasting no less then 3 months after the hernia repair. Patients are allowed to resume their full activities after 10 days from surgery, expect for physical exercise which we recommend wait almost 30 days from surgery. Time of surgery has been recorded. Length of post-operative stay as well as postoperative complications occurring up to 1 year after surgery have been prospectively recorded. Seroma is defined when it is symptomatic (pain, discomfort, etc.,) and that tends to persist for long periods from surgery (>1 month) and which often requires an interventional therapeutic approach (needle aspiration). 2.3. SF-36 quality of life Quality of life was assessed with the medical outcomes study SF36 questionnaire (Spanish form) preoperatively and at 2, 6 and 12 months after surgery. The scales include the physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). These scales are divided into two main branches which measure physical component (PC) and mental component (MC). For each patient, the questionnaire was sent by mail. Data was elaborated and scored.7 2.4. Pain Postoperative pain was determinated at first and 7th day after surgery and at 2, 6 and 12 months, using the standardized 0e10 visual analgesic scale (VAS). After the discharge it is gathered in outpatient clinic. 2.5. Ethics The study was approved by the institutional ethical committee of Sanchinarro University Hospital and all patients included were informed about the treatment and a written informed consent was obtained. All patients who met the criteria were offered for entry into the study. 2.6. Statistics

Fig. 1. Trocars placement.

Data has been recorded in a SPSS Statistics Version 20.0 database. To compare the means of the quantitative variables when the variables followed a normal distribution, a variance analysis and a Student's t-test were used. For the rest of the variables, both

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ManneWhitney and KruskaleWallis tests were performed. Statistical significance was defined as having a P value of <0.05. Data herein reported are for patients which reach a minimum of one year of follow up.

the first postoperative day and 1.8 (range: 1e4) in the TAPP group Vs 3.2 (range: 1e5) in the OLR group (p ¼ 0.03) on the seventh postoperative day. At 2, 6 and 12 months after surgery no difference was recorded in postoperative pain as showed in Fig. 2.

3. Results

3.5. Quality of life

3.1. Patient characteristics

No statistical differences were recorded in terms of preoperative quality of life between groups according to the SF36 questionnaire6 (75.3, range: 65e87; and 74.8, range 66e86 for TAPP and OLR, respectively; p ¼ 0.8). In both groups, the mean scores increased constantly during the follow-up period (Fig. 3). At 2 months from surgery there is a slight higher score in the TAPP procedure (95.7 Vs 90.8; p ¼ 0.06). Regarding the PC subscale, only at 2 months from surgery, we found a significative higher score in the TAPP group (mean: 84.1) compared with the ORL (mean: 81.3; p ¼ 0.04) (Fig. 4).

The median duration of follow up was 18.6 months (range: 12e41 months). TAPP was performed in 61 cases and ORL in 73 cases. Clinical and perioperative data comparison of both groups are summarized in Table 1. 3.2. Short term postoperative outcome The mean operative time was 100.3 min (range: 60e130 min) for the TAAP group Vs 97.1 min (range: 60e120 min) for the OLR group and no statistical difference was recorded (Table 2). The mean hospital stay was significantly shorter for the TAAP group (1.03 days; range: 1e2 days) compared with the OLR group (1.41 days; range: 1e5 days) (p ¼ 0.001) (Table 2). 3.3. Long term postoperative outcome Post-operative complications are depicted in Table 2 and occurred in 5 patients in the TAAP group (8%) and in 19 patients in the OLR group (26%) (p ¼ 0.012). Number of patients with BMI 25 were equally distributed among the two groups (32% in TAPP Vs 34% in OLR; p ¼ 0.6) (Table 1). In the ORL group, a statistically higher number of patients which suffered from complications (79%; 15/19) were with a BMI  25 (p ¼ 0.001) (Table 2). In the TAPP group, 40% of patients which suffered from complications were with a BMI 25 (p ¼ 0.7). Chronic pain was reported by 1 patients in the TAPP group (1.64%) and by 9 patients in the OLR group (12.3%) (p ¼ 0.04). Hernia recurrence was recorded in 6.6% and 5.5% of the cases for the TAPP and OLR group, respectively (p ¼ 0.7) (Table 2). 3.4. Postoperative pain Preoperative pain was assessed by VAS and was similar between the 2 groups (Fig. 2). Early postoperative pain assessed on the first and seventh postoperative day was significantly lower for the TAPP group: 2.6 (range: 1e5) Vs 4.6 (range: 1e6) for the OLR group (p ¼ 0.001) on Table 1 Patients baseline characteristics.

Mean age (range) years Mean BMI (Kg/m2) BMI  25 (n, %) Male/Female ASA (n) I II III EHS (n) I II III Mean hernia size (cm)

TAPP (n ¼ 61)

OLR (n ¼ 73)

p

52 (31e70) 24.9 20 (32%) 48/2

54.7 (27e70) 25.5 25 (34%) 68/5

0.19 0.4 0.6 0.2 0.4

15 41 5

12 57 4

29 22 10 2.3

41 20 12 1.9

0.4

4. Discussion TAPP approach in inguinal hernia repair has been shown to be a valid alternative to traditional OLR.3,8 Furthermore, the laparoscopic approach showed less post-operative pain and a shorter length of hospital stay.1,9 These advantages are expected to be more evident for bilateral inguinal hernias. However, only few reports address the difference among TAPP and OLR in bilateral inguinal hernia repair10 and, to the best of our knowledge, none of them provide quantitative information about the difference in the quality of life. The aim of this paper is to study which are the differences between the TAPP and the OLR approach for bilateral inguinal hernia. We found that the mean operative time was only slightly higher in the TAPP compared with the OLR approach (110.3 vs 97.1 min; p ¼ 0.23). This study confirmed that the minimally invasive approach is associated with less early post-operative pain compared with the OLR. The difference between the mean VAS on the first and seventh post-operative day in bilateral inguinal hernias is higher compared with other studies which includes only monolateral hernias. This data supports that the major benefit of laparoscopic approach is when it is used for bilateral inguinal hernias. In fact, in the TAPP approach, through the same access, it is possible to repair both sides, whereas the traditional OLR technique needs a double inguinal incision, increasing pain and discomfort in the early postoperative period. According to our study, during the early postoperative period up to 7 days from surgery, pain was significantly lower in the TAPP group compared with the ORL group (Fig. 2). In the late post-operative time, VAS is similar in both groups; however, as reported in Fig. 2, there still exists a slight trend towards less pain in the TAPP group. Postoperative pain and complications are closely related. One of the reasons for less postoperative pain in the TAPP procedure lies mainly in the lower rate of complications that occurred in this approach.11e14 As shown in Table 2, only in 8% of cases a complication occurred in the TAPP group and 26% in the OLR group (p ¼ 0.012). Again, this difference is more significative then other studies because we only include bilateral hernias.15e17 Even if all these complications were minors, this data further backs up the hypothesis that the laparoscopic approach entails more advantages in the case of bilateral hernias. Most of the complications that occurred in the OLR technique are specifically related to the inguinal incision (seroma, hematoma, infection). They are more likely to occur in the inguinal area rather than in different abdominal areas, such as those occurring in laparoscopic approach.8,14

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Table 2 Intra and post-operative outcome.

Mean operative time (range) min Mean hospital stay (range) days Overall postoperative complications (n; %) Total Wound hematoma Wound seroma Wound infection Urinary retention Orchitis Complications occurred in patients with BMI > 25 n/total (%) p Recurrence (n; %) Chronic pain (n; %)

TAPP (n ¼ 61)

OLR (n ¼ 73)

p

100.3 (60e130) 1.03 (1e2)

97.1 (60e120) 1.41 (1e5)

0.23 0.001

5 (8%) 4 0 0 0 1 2/5 (40%) p > 0.5 4 (6.6%) 1 (1.64%)

19 (26%) 5 10 2 2 0 15/19 (79%) p ¼ 0.001 4 (5.5%) 9 (12.3%)

0.012

0.001 0.7 0.04

Bold signifies the statistically significant.

Most of these complications occurred mainly in obese patients in the ORL group. In fact, the 79% of patients which suffered complications had a BMI higher than 25, compared with 40% of the TAPP group (Table 2). Therefore, obesity should be a strong indication for inguinal hernia repair through a laparoscopic approach. Reported recurrence rates after laparoscopic inguinal hernia repair are 0e4%. However, its incidence in bilateral hernias is not well known as only little data has been reported. In most of these series, the population is not homogeneous and usually contralateral hernia repair is only because of an intraoperative finding.11,12,15 We only included patients with clinical and radiological evidence of bilateral hernia in our study. Our data suggests that recurrence rate is similar between both groups, despite there being a slightly higher incidence rate in the TAPP group (6.6% vs 5.5%; p ¼ 0.7). In some studies, in the first period of time, the laparoscopic inguinal hernia repair was associated with an increased risk of recurrence compared with the traditional open approach. The main reason for this was the inclusion of data from surgeons with less experience in this approach. As for all surgeries, the learning curve is paramount in order to achieve good results.8,16 For laparoscopic hernia repair, the EHS group stated that a learning curve is necessary, but the number of procedures required to pass it is still a question of debate. The surgeons who participated in this study had performed a minimum of 10 TAPP procedures before the study started. Furthermore, in all procedures there was always a more experienced surgical assistant. This is the reason why our recurrence rate

is low and similar to the OLR.16e18 Chronic postoperative pain syndrome still remains a problem for traditional open approach.2 In fact, several studies indicate that up to 30% of patients report pain at 1 year following inguinal hernia repair.2 In our experience, as described in other studies, chronic pain has been found to be significantly higher in the OLR group (TAPP: 1.64%; OLR: 12.3%; p ¼ 0.04).1,10,18 The main reason for lower chronic pain in the TAPP procedure might be the different space placement of the mesh compared with the traditional open approach. However, this issue merit to be better addressed. Postoperative complications like seroma and hematoma are considered as risk factors for chronic pain after inguinal hernia repair.14e16 As expected, they are higher in the OLR group, justifying the higher incidence of chronic pain in this group. Our results also suggest that length of hospitalization of the TAPP group was significantly lower compared with the OLR group. The higher post-operative pain and complication rate in the OLR group might contribute to the increased length of hospital stay in this group (1.03 vs 1.41; p ¼ 0.001). In terms of quality of life, the differences between the two groups of SF-36 were not significant. However, our finding regarding the PC shows that there is a better perception of it in the TAPP group at 2 months from surgery (p ¼ 0.04). We consider that it might be useful to report a case of a patient whom MC score showed a low quality of life after an uneventful TAPP procedure. We interviewed the patient and transpired that

Fig. 2. Visual Analgesic Scale (VAS) score (at 1 day p ¼ 0.001; at 7 days p ¼ 0.003; at 2 months and 1 year p > 0.5).

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Fig. 3. SF-36 scores (at 2 months p ¼ 0.06).

the reason for such a low score was due to the location of the three laparoscopic incisions in the abdomen. The patient was a body builder with particular interest in the care of his abdomen. In retrospect, this patient might have preferred an open traditional inguinal repair for his hernias due to a better cosmetic result with an absence of abdominal incisions. Cosmesis results are difficult to evaluate as its importance might be different for each patient. Do we have to perform minimally invasive approach in all hernia repairs? Each case must be evaluated with the patients. This study has the limitation that we did not include a comparison of the cost effectiveness of both procedures in our analysis. We purposefully chose to not report it, because on the one hand it is easy to record the cost of the surgery (surgical materials, hospital stay, dressing, etc …), on the other hand, it is difficult to measure

the cost of the post-operative complications (work leave, medications, etc …). Therefore, cost comparison might be not proper. A confounder factor might be the different type of anesthesia used for the two approaches (epidural for OLR and general anesthesia for TAPP). However, OLR is worldwide performed by epidural anesthesia which, in our opinion, best represents the standard technique to compare with TAPP. The unicentric nature of this study guarantees the homogeneity of the surgical procedures. In fact, most of the studies which compare laparoscopic vs open techniques include several centers with different surgical procedures (different type and size of mesh, different type of peritoneal flap close, etc …) that may invalidate some results.

Fig. 4. SF-36 scores physical component subscale (at 2 months p ¼ 0.04).

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5. Conclusions The present study showed that TAPP approach for bilateral inguinal hernia repair is safe and reduces early post-operative pain. Furthermore, it is related to less complications and shorter hospital stay when compared with OLR. A slight better quality of life perception has been found in the TAPP compared with the OLR approach. Financial disclosures All the authors (Benedetto Ielpo, Hipolito Duran, Eduardo Diaz, , Valentina Ferri, Sara Isabel Fabra, Riccardo Caruso, Luis Malave Lazzaro, Denis Kalivaci, Yolanda Quijano, Emilio Vicente) declare any relevant financial activities related to this study. Conflict of interest The authors declare no conflict of interest. Acknowledgments The authors thanks Isabel de Salas, Pablo Ruiz and Beatriz Sanchez for their important contribution. References 1. Claus CM, Rocha GM, Campos AC, et al. Prospective, randomized and controlled study of mesh displacement after laparoscopic inguinal repair: fixation versus no fixation of mesh. Surg Endosc. 2016;30(3):1134e1140. http://dx.doi.org/ 10.1007/s00464-015-4314-7. 2. O'Reilly Elma A, Burke John P, O'Connell P Ronan. A meta-analysis of surgical morbidity and recurrence after laparoscopic and open repair of primary unilateral inguinal hernia. Ann Surg. 2012;255(5):846e853. http://dx.doi.org/ 10.1097/SLA.0b013e31824e96cf. 3. Bittner R, Montgomery MA, Arregui E, et al. Update of guidelines on laparoscopic (TAPP) and endoscopic (TEP) treatment of inguinal hernia (International Endohernia Society). Surg Endosc. 2015;29(2):289e321. http://dx.doi.org/ 10.1007/s00464-014-3917-8. 4. Antoniou SA, Antoniou GA, Bartsch DK, et al. Transabdominal preperitoneal versus totally extraperitoneal repair of inguinal hernia: a meta-analysis of randomized studies. Am J Surg. 2013;206(245e252):e1. http://dx.doi.org/ 10.1016/j.amjsurg.2012.10.041.

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5. Miserez M, Alexandre JH, Campanelli G, et al. The European hernia society groin hernia classification: simple and easy to remember. Hernia. 2007;11(2): 113e116. 6. Chen DC, Amid PK. Prevention of inguinodynia: the need for continuous refinement and quality improvement in inguinal hernia repair. World J Surg. 2014;38(10):2571e2573. 7. Vilaguta Gemma, Ferrera Montse, Rajmilb Luis, et al. El Cuestionario de Salud ~ ol: una de cada de experiencia y nuevos desarrollos. Gac Sanit. SF-36 espan 2005;19(2). http://dx.doi.org/10.1590/S0213-91112005000200007. 8. Simons MP, Aufenacker T, Bay-Nielsen M, et al. European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia. 2009;13(4):343e403. http://dx.doi.org/10.1007/s10029-009-0529-7. 9. Ross SW, Oommen B, Kim M, et al. Tacks, staples, or suture: method of peritoneal closure in laparoscopic transabdominal preperitoneal inguinal hernia repair effects early quality of life. Surg Endosc. 2015;29(7):1686e1693. http:// dx.doi.org/10.1007/s00464-014-3857-3.  H, Petter-Puchner Alexander H, Redl Heinz, et al. Assessment of 10. Fortelny Rene pain and quality of life in Lichtenstein hernia repair using a new monofilament PTFE mesh: comparison of suture vs. Fibrin-Sealant mesh fixation. Front Surg. 2014;1:45. http://dx.doi.org/10.3389/fsurg.2014.00045. 11. Wijerathne S, Agarwal N, Ramzi A, et al. Single-port versus conventional laparoscopic total extra-peritoneal inguinal hernia repair: a prospective, randomized, controlled clinical trial. Surg Endosc. 2016;30(4):1356e1363. http:// dx.doi.org/10.1007/s00464-015-4378-4. € nka € K, Vironen J, Ko €ssi J, et al. Randomized multicenter trial comparing glue 12. Ro fixation, self-ygripping mesh, and suture fixation of mesh in Lichtenstein hernia repair (FinnMesh study). Ann Surg. 2015;262(5):714e719. http:// dx.doi.org/10.1097/SLA.0000000000001458. discussion 719-20. 13. Burgmans JP, Voorbrood CE, Simmermacher RK, et al. Long-term results of a randomized double-blinded prospective trial of a lightweight (Ultrapro) versus a heavyweight mesh (Prolene) in laparoscopic total extraperitoneal inguinal hernia repair (TULP-trial). Ann Surg. 2016;263(5):862e866. http://dx.doi.org/ 10.1097/SLA.0000000000001579. 14. Wennergren JE, Plymale M, Davenport D, et al. Quality-of-life scores in laparoscopic preperitoneal inguinal hernia repair. Surg Endosc. 2016;30(8): 3467e3473. http://dx.doi.org/10.1007/s00464-015-4631-x. 15. Oguz H, Karagulle E, Turk E, Moray G. Comparison of peritoneal closure techniques in laparoscopic transabdominal preperitoneal inguinal hernia repair: a prospective randomized study. Hernia. 2015;19(6):879e885. http://dx.doi.org/ 10.1007/s10029-015-1431-0. 16. Lovisetto F, Zonta S, Rota E, et al. Use of human fibrin glue (Tissucol) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty: a prospective, randomized study. Ann Surg. 2007;245(2):222e231. 17. Sharma D, Yadav K, Hazrah P, et al. Prospective randomized trial comparing laparoscopic transabdominal preperitoneal (TAPP) and laparoscopic totally extra peritoneal (TEP) approach for bilateral inguinal hernias. Int J Surg. 2015;22:110e117. http://dx.doi.org/10.1016/j.ijsu.2015.07.713. €ckerling F, Stechemesser B, Hukauf M, et al. TEP versus Lichtenstein: which 18. Ko technique is better for the repair of primary unilateral inguinal hernias in men? Surg Endosc. 2016;30(8):3304e3313. http://dx.doi.org/10.1007/s00464-0154603-1.