Laparo-endoscopic versus open recurrent inguinal hernia repair: should we follow the guidelines?

Introduction On the basis of six meta-analyses, the guidelines of the European Hernia Society (EHS) recommend laparo-endoscopic recurrent repair following previous open inguinal hernia operation and, likewise, open repair following previous laparo-endoscopic operation. So far no data are available on implementation of the guidelines or for comparison of outcomes. Besides, there are no studies for comparison of outcomes for compliance versus non-compliance with the guidelines. Patients and methods In total, 4812 patients with elective unilateral recurrent inguinal hernia repair in men were enrolled between September 1, 2009, and September 17, 2014, in the Herniamed Registry. Only patients with 1-year follow-up were included. Results Out of the 2482 laparo-endoscopic recurrent repair operations 90.5% of patients, and out of the 2330 open recurrent repair procedures only 38.5% of patients, were operated on in accordance with the guidelines of the EHS. Besides, on compliance with the guidelines multivariable analysis demonstrated for laparo-endoscopic recurrent repair a significantly lower risk of pain at rest (OR 0.643 [0.476; 0.868]; p = 0.004) and pain on exertion (OR 0.679 [0.537; 0.857]; p = 0.001). Comparison of laparo-endoscopic and open recurrent repair in settings of compliance versus non-compliance with the guidelines showed a higher incidence of perioperative complications and re-recurrences for recurrent repairs that did not comply with the guidelines. Conclusion The EHS guidelines for recurrent inguinal hernia repair are not yet being observed to the extent required. Non-compliance with the guidelines is associated with higher perioperative complication rates and higher risk of re-recurrence. Even on compliance with the guidelines, the risk of pain at rest and pain on exertion is higher after open recurrent repair than after laparo-endoscopic repair.

On the basis of the meta-analyses, the European Hernia Society recommends laparo-endoscopic inguinal hernia repair of recurrent hernias after conventional open repair [8,23] and for recurrent hernias after laparo-endoscopic hernia repair an open procedure. Likewise, the International Endohernia Society recommends, with a high level of evidence, TEP and TAPP for repair of recurrent hernia as the preferred alternative to tissue repair and to the Lichtenstein repair after prior anterior repair [24,25]. In the Consensus Development Conference of the European Association of Endoscopic Surgery, TEP and TAPP are preferred in patients with a recurrent groin hernia after open repair. Repeat endoscopic repair is only feasible when the surgeon has a high level of experience in repeat endoscopic groin hernia repair [26]. However, registry data show that even following previous open suture and mesh repair to treat the primary inguinal hernia, open suture and mesh repair are used once again for a recurrent hernia [27]. That is due to the fact that the skill needed for laparoendoscopic recurrent inguinal hernia repairs was not always assured. Where surgeons had used an open technique to repair 95% of primary inguinal hernias, then more than 90% of recurrences were also repaired using an open procedure [28]. That was also true when using mesh repair for the primary inguinal hernia operation [13].
This present analysis of data from the Herniamed Hernia Registry [29] now investigates: (1) To what extent surgeons implement the guidelines of the international hernia societies. (2) Since to date no study has compared the outcomes of open and laparo-endoscopic recurrent inguinal hernia repair carried out in compliance with the guidelines, that aspect will now also be explored in the present analysis. (3) Finally, how the outcomes of open and laparoendoscopic recurrent inguinal hernia repair differ on compliance versus non-compliance with the guidelines.

Patients and methods
The Herniamed Registry is a multicenter, Internet-based hernia registry [29] into which 427 participating hospitals and surgeons engaged in private practice (Herniamed Study Group) have entered data prospectively on their patients who had undergone routine hernia surgery and signed an informed consent to participate. All postoperative complications occurring up to 30 days after surgery are recorded. On 1-year follow-up, postoperative complications are once again reviewed when the general practitioner and patient complete a questionnaire. Information is also obtained on any recurrence, pain at rest and on exertion as well as pain requiring treatment. This present analysis compares the prospective data collected for all male patients with a minimum age of 16 years who had undergone elective recurrent unilateral inguinal hernia repair using either transabdominal preperitoneal patch plasty (TAPP), total extraperitoneal patch plasty (TEP) or open repair in Lichtenstein, Should ice, TIPP and Plug techniques.
The dependent variables were intra-and postoperative complication rates, number of reoperations due to complications as well as the 1-year results (recurrence rate, pain at rest, pain on exertion and pain requiring treatment).
All analyses were performed with the software 9.2 (SAS 9.2 Institute Inc. Cary, NY, USA) and intentionally calculated to a full significance level of 5%, i.e., they were not corrected in respect of multiple tests, and each p value B0.05 represents a significant result. To discern differences between the groups in unadjusted analyses, Fisher's exact test was used for categorical outcome variables and the robust t-test (Satterthwaite) for continuous variables.
To rule out any confounding of data caused by different patient characteristics, the results of unadjusted analyses were verified via multivariable analyses in which, in addition to laparo-endoscopic or open operation, other influence parameters were simultaneously reviewed.
To identify influence factors in multivariable analyses, the binary logistic regression model for dichotomous outcome variables was used. Estimates for odds ratio (OR) and the corresponding 95% confidence interval based on the Wald test were given. For influence variables with more than two categories, one of the latter forms was used in each case as reference category. For age (years) the 10-year OR estimate and for BMI (kg/m 2 ) the five-point OR estimate were given. Results were presented in tabular form, sorted by descending impact.

1.
To what extent do surgeons follow the guidelines?
Accordingly, in the laparo-endoscopic recurrent repair group 90.5%, and in the open recurrent repair group 38.5%, of patients were operated on in compliance with the guidelines of the international hernia societies.  (Table 1). Unadjusted analysis did not find any significant difference in the mean age between the two groups; however, the mean BMI value was higher for those patients undergoing open recurrent repair ( Table 2). The open recurrent repair was associated with significantly larger hernia defects, more medial, fewer femoral and lateral EHS classifications (Table 3). No differences were identified in the risk factors (  In the laparo-endoscopic recurrent operation group, the recurrent operation was performed for n = 233/2482 (9.4%) patients following laparo-endoscopic primary mesh repair, i.e., not in compliance with the guidelines of the international hernia societies (Table 9). These cases are compared below with the n = 2246/2482 (90.6%) patients who were operated on in compliance with the guidelines, with laparo-endoscopic procedure for recurrent repair following previous open primary inguinal hernia operation (Table 9). No significant difference was identified between the two groups with regard to the mean age and BMI (Table 10). The laparo-endoscopic recurrent repairs not conducted in compliance with the guidelines revealed a significantly higher proportion of larger defects as well as a smaller proportion of lateral inguinal hernia recurrences (Table 11). No relevant differences were found for the other variables and risk factors. When recurrent repair was performed as per the guidelines, the laparo-endoscopic procedure was found to be associated with fewer intraoperative (1.2 vs 3.0%; p = 0.019) and postoperative For multivariable analysis of the intraoperative complications, complication-related reoperations and re-recurrences, it was not possible to calculate a valid model on In the open recurrent repair group, only n = 897/2.320 (38.5%) of operations were performed following previous primary laparo-endoscopic inguinal hernia repair, i.e., according to the guidelines. Conduct of open recurrent repair following previous suture procedure for the primary inguinal hernia repair (n = 1.011/2.320; 43.4%) and after mesh procedure (n = 412/2.320; 17.7%) was not in compliance with the guidelines (Table 14). Below are now compared the open recurrent inguinal hernia repair procedures conducted on compliance (n = 897/2.320; 38.5%) versus non-compliance with the guidelines (n = 1.423/ 2.320; 61.3%).
Patients with recurrent inguinal hernias repaired in accordance with the guidelines had a significantly lower age and higher BMI (Table 15). Furthermore, patients operated on with an open procedure as per the guidelines had a significantly lower ASA score, smaller hernia defects, fewer risk factors and fewer lateral and scrotal hernias (Table 16). When the recurrent repair was   Table 17). For multivariable analysis of the intraoperative complications, complication-related reoperations and re-recurrences, it was not possible to calculate a valid model since the number of positive cases was too small. Univariable analysis of chronic pain requiring treatment did not detect any difference for repair as per the guidelines; therefore, no multivariable model was calculated.
The multivariable analysis results of variables influencing onset of postoperative complications are given in Table 18 (model matching: p = 0.002).
The postoperative complications were only affected by age, with older patients 1.498]; p = 0.003) having a higher risk of postoperative complications. There was no evidence that repair as per the guidelines impacted the postoperative complications. Another descriptive analysis revealed that the increased risk of pain at rest was attributed primarily to the smallsized (\1.5 cm) and medium-sized (1.5-3 cm) hernias (Table 20). The multivariable analysis results for pain on exertion are illustrated in Table 21 (model matching: p \ 0.001). These were significantly influenced by the hernia defect size (p = 0.002), repair as per the guidelines (p = 0.010), BMI (p = 0.023), age (p = 0.027) and scrotal EHS classification (p = 0.036). A higher age 0.988 [1.029; 1.456]). Likewise, for pain on exertion the risk was attributable, in particular, to small-sized (\1.5 cm) and medium-sized (1.5-3 cm) recurrent hernias (Table 22).

Discussion
1. The present analysis of data from the Herniamed Registry [29] first investigated to what extent participants in the Herniamed Hernia Registry [29] complied with the recommendations set out in the guidelines of the European Hernia Society (EHS). This revealed that laparo-endoscopic recurrent repair was used in 61.6% of cases following previous open suture repair and in 28.9% cases following open mesh repair as well as in 9.4% of cases following previous laparo-endoscopic operations. Hence, more than 90% of laparo-endoscopic recurrent repair procedures were performed in accordance with the EHS guidelines. Only 9.4% did not comply with the guidelines.
Matters were different for open recurrent repair. Only 38.5% of open recurrent repair operations were conducted following primary laparo-endoscopic repair. 43.4% of open recurrent repair procedures were performed following previous open suture repair and 17.7% following previous open mesh repair. As such, more than 60% of open recurrent operations did not comply with the recommendations of the guidelines. Already Richards et al. [13] and Richards and Earnshaw [28] pointed out that surgeons using predominantly open hernia surgery techniques also use predominantly open surgery for recurrent repair. It appears that the guidelines, which were first published in Mere deviation from a guideline is unlikely to be considered as malpractice in litigation, unless the practice concerned is so well established that no responsible surgeon would fail to adhere to it [31]. 2. To date, no study has compared the outcomes of recurrent inguinal hernia repair carried out in compliance with the guidelines. Therefore, the present analysis of Herniamed data [29] compared laparo-endoscopic with open recurrent repair performed as per the guidelines. No Multivariable analysis confirmed that laparo-endoscopic repair had a significant impact on pain at rest and pain on exertion, and was associated with a lower pain rate compared with open recurrent repair. Even on compliance with the guidelines, a significantly higher rate of pain at rest and pain on exertion must be expected when open repair is used following previous laparo-endoscopic operations compared with laparo-endoscopic repair after previous open repair. Therefore, such recurrent repair operations should be performed by surgeons who are highly experienced in the respective technique. Therefore, despite observance of the guidelines, higher rates of pain at rest and pain on exertion must be expected on using open recurrent repair following primary laparo-endoscopic repair than when using laparoendoscopic recurrent repair following primary open repair. 3. In particular, since a large number of open (61.1%) and also a smaller number of laparo-endoscopic (9.4%) recurrent repair procedures were not performed in accordance with the recommendations of the guidelines, the question arises as to how the outcomes compare with the respective repair procedures carried out in compliance with the guidelines.
If recurrent repair is conducted as per the guidelines, laparo-endoscopic repair is associated with fewer intraoperative and postoperative complications and with a lower re-recurrence rate. No difference was found for the pain rates. Multivariable analysis demonstrated especially for the postoperative complications the impact of repair as per the guidelines. Comparison of open recurrent repair conducted on compliance versus non-compliance with the guidelines revealed fewer postoperative complications and complication-related reoperation rates as well as a lower re-recurrence rate following repair as per the guidelines. On the other hand, the risk of pain at rest and on exertion was higher on compliance with the guidelines. Multivariable analysis revealed that the postoperative complications were only affected by age but not by the use of a repair procedure in accordance with the guidelines. Matters were different for pain at rest and pain on exertion. For the latter, multivariable analysis confirmed that repair as per the guidelines exerted a significantly negative effect on onset of pain at rest and pain on exertion. However, multivariable analysis as well as an additional analysis demonstrated that a small defect size had the greatest impact on the risk of pain at rest and pain on exertion. Likewise, a higher BMI negatively impacted the risk of pain at rest and pain on exertion. Although recommended in the guidelines, patients with a small defect size and a higher BMI have a higher risk of pain at rest and exertion following open repair of a recurrence after a previous laparo-endoscopic inguinal hernia repair. Therefore, sufficient diagnostic work-up of a small recurrence as cause of groin pain is mandatory.
In summary, it can be stated that in the Herniamed Registry (1) 90% of the laparo-endoscopic and only 40% of open recurrent inguinal hernia repair operations are carried out in accordance with the EHS guidelines; (2) comparison of laparo-endoscopic with open recurrent repair conducted in accordance with the guidelines demonstrated that open recurrent repair as per the guidelines was associated with a higher risk of pain at rest and pain on exertion on 1-year follow-up; and (3) finally, comparison of recurrent repair procedures on compliance versus non-compliance with the guidelines showed that both laparo-endoscopic and open repair operations that did not comply with the guidelines presented a higher risk of perioperative complications and re-recurrences. As such, the recommendations set out in the EHS guidelines should be implemented, but considering the specific circumstances of a given patient.