Are immunosuppressive conditions and preoperative corticosteroid treatment risk factors in inguinal hernia repair?

INTRODUCTION: Immunosuppressive conditions and/or preoperative corticosteroid treatment have a negative influence on wound healing and can, therefore, lead to higher rates of surgical site infections (SSIs) and seromas. For inguinal hernia, no such studies have been carried out to date. METHODS: In an analysis of data from the Herniamed Registry, 2312 of 142,488 (1.6%) patients with primary unilateral inguinal hernia repair had an anamnestic history of an immunosuppressive condition and/or preoperative corticosteroid treatment. Using propensity score matching, 2297 (99.4%) pairs with comparative patient characteristics were formed. These were then compared using the following primary outcome criteria: intra- and postoperative complications, complication-related reoperations, recurrence at one-year follow-up, pain on exertion, pain at rest, and chronic pain requiring treatment at one-year follow-up. Of the 2297 matched pairs with primary unilateral inguinal hernia repair, 82.76% were male patients. 1010 (44.0%) were operated in laparo-endoscopic techniques (TEP, TAPP), 1225 (53.3%) in open techniques (Bassini, Shouldice, Lichtenstein, Plug, TIP, Gilbert, Desarda), and 62 (2.7%) in other techniques. RESULTS: The matched pair analysis results did not identify any disadvantage in terms of the outcome criteria for patients with an anamnestic history of immunosuppressive condition and/or preoperative corticosteroid treatment (yes vs no). In particular, no disadvantage was noted in the rate of surgical site infections (0.65% vs 0.70%; ns) or seromas (1.22% vs 1.57%; ns). The overall rates of postoperative complications were 3.40% vs 4.31% (p = ns) (plus 0.22% concordant events in five matched pairs). CONCLUSION: In primary unilateral inguinal hernia surgery, an immunosuppressive condition and/or preoperative corticosteroid treatment does not appear to have a negative influence on wound complications.

Laparoscopic IPOM versus open sublay technique for elective incisional hernia repair: a registry-based, propensity score-matched comparison of 9907 patients.

BACKGROUND: For comparison of laparoscopic IPOM versus sublay technique for elective incisional hernia repair, the number of cases included in randomized controlled trials and meta-analyses is limited. Therefore, an urgent need for more comparative data persists. METHODS: In total, 9907 patients with an elective incisional hernia repair and 1-year follow-up were selected from the Herniamed Hernia Registry between September 1, 2009 and June 1, 2016. Using propensity score matching, 3965 (96.5%) matched pairs from 4110 laparoscopic IPOM and 5797 sublay operations were formed for comparison of the techniques. RESULTS: Comparison of laparoscopic IPOM versus open sublay revealed disadvantages for the sublay operation regarding postoperative surgical complications (3.4% vs. 10.5%; p < 0.001), complication-related reoperations (1.5% vs. 4.7%; p < 0.001), and postoperative general complications (2.5% vs. 3.7%; p = 0.004). The majority of surgical postoperative complications were surgical site infection, seroma, and bleeding. Laparoscopic IPOM had disadvantages in terms of intraoperative complications (2.3% vs. 1.3%; p < 0.001), mainly bleeding, bowel, and other organ injuries. No significant differences in the recurrence and pain rates at 1-year follow-up were observed. CONCLUSION: Laparoscopic IPOM was found to have advantages over the open sublay technique regarding the rates of both surgical and general postoperative complications as well as complication-related reoperations, but disadvantages regarding the rate of intraoperative complications.

Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)): Part B.

In 2014 the International Endohernia Society (IEHS) published the first international "Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias". Guidelines reflect the currently best available evidence in diagnostics and therapy and give recommendations to help surgeons to standardize their techniques and to improve their results. However, science is a dynamic field which is continuously developing. Therefore, guidelines require regular updates to keep pace with the evolving literature. METHODS: For the development of the original guidelines all relevant literature published up to year 2012 was analyzed using the ranking of the Oxford Centre for Evidence-Based-Medicine. For the present update all of the previous authors were asked to evaluate the literature published during the recent years from 2012 to 2017 and revise their statements and recommendations given in the initial guidelines accordingly. In two Consensus Conferences (October 2017 Beijing, March 2018 Cologne) the updates were presented, discussed, and confirmed. To avoid redundancy, only new statements or recommendations are included in this paper. Therefore, for full understanding both of the guidelines, the original and the current, must be read. In addition, the new developments in repair of abdominal wall hernias like surgical techniques within the abdominal wall, release operations (transversus muscle release, component separation), Botox application, and robot-assisted repair methods were included. RESULTS: Due to an increase of the number of patients and further development of surgical techniques, repair of primary and secondary abdominal wall hernias attracts increasing interests of many surgeons. Whereas up to three decades ago hernia-related publications did not exceed 20 per year, currently this number is about 10-fold higher. Recent years are characterized by the advent of new techniques-minimal invasive techniques using robotics and laparoscopy, totally extraperitoneal repairs, novel myofascial release techniques for optimal closure of large defects, and Botox for relaxing the abdominal wall. Furthermore, a concomitant rectus diastasis was recognized as a significant risk factor for recurrence. Despite still insufficient evidence with respect to these new techniques it seemed to us necessary to include them in the update to stimulate surgeons to do research in these fields. CONCLUSION: Guidelines are recommendations based on best available evidence intended to help the surgeon to improve the quality of his daily work. However, science is a continuously evolving process, and as such guidelines should be updated about every 3 years. For a comprehensive reference, however, it is suggested to read both the initially guidelines published in 2014 together with the update. Moreover, the presented update includes also techniques which were not known 3 years before.

Correction to: Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS))-Part A.

This article was updated to include the middle initial of author L. N. Jorgensen's name.

Update of Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS))-Part A.

In 2014, the International Endohernia Society (IEHS) published the first international "Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias." Guidelines reflect the currently best available evidence in diagnostics and therapy and give recommendations to help surgeons to standardize their techniques and to improve their results. However, science is a dynamic field which is continuously developing. Therefore, guidelines require regular updates to keep pace with the evolving literature. METHODS: For the development of the original guidelines, all relevant literature published up to year 2012 was analyzed using the ranking of the Oxford Centre for Evidence-Based Medicine. For the present update, all of the previous authors were asked to evaluate the literature published during the recent years from 2012 to 2017 and revise their statements and recommendations given in the initial guidelines accordingly. In two Consensus Conferences (October 2017 Beijing, March 2018 Cologne), the updates were presented, discussed, and confirmed. To avoid redundancy, only new statements or recommendations are included in this paper. Therefore, for full understanding both of the guidelines, the original and the current, must be read. In addition, the new developments in repair of abdominal wall hernias like surgical techniques within the abdominal wall, release operations (transversus muscle release, component separation), Botox application, and robot-assisted repair methods were included. RESULTS: Due to an increase of the number of patients and further development of surgical techniques, repair of primary and secondary abdominal wall hernias attracts increasing interests of many surgeons. Whereas up to three decades ago hernia-related publications did not exceed 20 per year, currently this number is about 10-fold higher. Recent years are characterized by the advent of new techniques-minimal invasive techniques using robotics and laparoscopy, totally extraperitoneal repairs, novel myofascial release techniques for optimal closure of large defects, and Botox for relaxing the abdominal wall. Furthermore, a concomitant rectus diastasis was recognized as a significant risk factor for recurrence. Despite insufficient evidence with respect to these new techniques, it seemed to us necessary to include them in the update to stimulate surgeons to do research in these fields. CONCLUSION: Guidelines are recommendations based on best available evidence intended to help the surgeon to improve the quality of his daily work. However, science is a continuously evolving process, and as such guidelines should be updated about every 3 years. For a comprehensive reference, however, it is suggested to read both the initial guidelines published in 2014 together with the update. Moreover, the presented update includes also techniques which were not known 3 years before.

A word of caution: never use tacks for mesh fixation to the diaphragm!

BACKGROUND: The mesh fixation technique used in repair of hiatal hernias and subxiphoid ventral and incisional hernias must meet strenuous requirements. In the literature, there are reports of life-threatening complications with cardiac tamponade and a high mortality rate on using tacks. The continuing practice of tack deployment for mesh fixation to the diaphragm and esophageal hiatus should be critically reviewed. METHODS: In a systematic search of the available literature in May 2017, 23 cases of severe penetrating cardiac complications were identified. The authors became aware of two other cases in which they acted as medical experts. Furthermore, the instructions for use issued by the manufacturers of the tacks were reviewed with regard to their deployment in the diaphragm. RESULTS: Twenty-three of 25 cases (92%) with severe cardiac injuries and subsequent cardiac tamponade were triggered by the use of tacks in the diaphragm. In six cases (24%), these related to ventral and incisional hernias with extension to the subxiphoid area, and in 19 cases (76%) to mesh-augmented hiatoplasty. Twelve of 25 (48%) patients died as a result of pericardial and/or heart muscle injury with cardiac tamponade despite heart surgery intervention. In the tack manufacturers' instructions for use, their deployment in the diaphragm, in particular in the vicinity of the heart, is contraindicated. Likewise, the existing guidelines urgently advise against the use of tacks in the diaphragm, recommending instead alternative fixation techniques. CONCLUSIONS: Tacks should not be used for mesh fixation in the diaphragm above the costal arch.

What are the influencing factors for chronic pain following TAPP inguinal hernia repair: an analysis of 20,004 patients from the Herniamed Registry.

BACKGROUND: In inguinal hernia repair, chronic pain must be expected in 10-12% of cases. Around one-quarter of patients (2-4%) experience severe pain requiring treatment. The risk factors for chronic pain reported in the literature include young age, female gender, perioperative pain, postoperative pain, recurrent hernia, open hernia repair, perioperative complications, and penetrating mesh fixation. This present analysis of data from the Herniamed Hernia Registry now investigates the influencing factors for chronic pain in male patients after primary, unilateral inguinal hernia repair in TAPP technique. METHODS: In total, 20,004 patients from the Herniamed Hernia Registry were included in uni- and multivariable analyses. For all patients, 1-year follow-up data were available. RESULTS: Multivariable analysis revealed that onset of pain at rest, on exertion, and requiring treatment was highly significantly influenced, in each case, by younger age (p < 0.001), preoperative pain (p < 0.001), smaller hernia defect (p < 0.001), and higher BMI (p < 0.001). Other influencing factors were postoperative complications (pain at rest p = 0.004 and pain on exertion p = 0.023) and penetrating compared with glue mesh fixation techniques (pain on exertion p = 0.037). CONCLUSIONS: The indication for inguinal hernia surgery should be very carefully considered in a young patient with a small hernia and preoperative pain.

Seroma following transabdominal preperitoneal patch plasty (TAPP): incidence, risk factors, and preventive measures.

BACKGROUND: The reported range of seroma formation in the literature after TEP repair is between 0.5 and 12.2% and for TAPP between 3.0 and 8.0%. Significant clinical factors associated with seroma formation include old age, a large hernia defect, an extension of the hernia sac into the scrotum, as well as the presence of a residual indirect sac. Seroma formation is a frequent complication of laparoendoscopic mesh repair of moderate to large-size direct (medial) inguinal hernia defects. This present analysis of data from the Herniamed Hernia Registry now explores the influencing factors for seroma formation in male patients after TAPP repair of primary unilateral inguinal hernia. METHODS: In total, 20,004 male patients with TAPP repair of primary unilateral inguinal hernia were included in uni- and multivariable analysis. RESULTS: Univariable analysis revealed the highly significant impact of the fixation technique on the seroma rate (non-fixation 0.7% vs. tacks 2.1% vs. glue 3.9%; p < 0.001). Multivariable analysis showed that glue compared to tacks (OR 2.077 [1.650; 2.613]; p < 0.001) and non-fixation (OR 5.448 [4.056; 7.317]; p < 0.001) led to an increased seroma rate. A large hernia defect (III vs. I: OR 2.868 [1.815; 4.531]; p < 0.001; II vs. I: OR 2.157 [1.410; 3.300]; p < 0.001) presented a significantly higher risk of seroma formation. Likewise, medial compared to lateral inguinal hernias had a higher seroma rate (OR 1.272 [1.020; 1.585]; p = 0.032). CONCLUSIONS: Mesh fixation with tacks or glue, a larger hernia defect, and medial defect localization present a higher risk for seroma development in TAPP inguinal hernia repair.

Has Shouldice Repair in a Selected Group of Patients with Inguinal Hernia Comparable Results to Lichtenstein, TEP and TAPP Techniques?

BACKGROUND: In the new international guidelines only the mesh-based Lichtenstein, TEP and TAPP techniques are recommended. This present analysis of data from the Herniamed Registry compares the outcome for Shouldice versus Lichtenstein, TEP and TAPP. METHODS: Propensity score matching analyses were performed to obtain homogeneous comparison groups for Shouldice versus Lichtenstein (n = 2115/2608; 81.1%), Shouldice versus TEP (n = 2225/2608; 85.3%) and Shouldice versus TAPP (2400/2608; 92.0%). RESULTS: The most important characteristics of the Shouldice patient collective were younger patients with a mean age of 40 years, a large proportion of women of 30%, a mean BMI value of 24 and a proportion of defect sizes up to 3 cm of over 85%. For this selected patient collective, propensity score matched-pair analysis did not identify any difference in the perioperative and one-year follow-up outcome compared with TAPP, fewer intraoperative (0.5 vs. 1.3%; p = 0.009) but somewhat more postoperative complications (2.3 vs. 1.5%; p = 0.050) compared with TEP and advantages with regard to pain at rest (4.6 vs. 6.1%; p = 0.039) and on exertion (10.0 vs. 13.4%; p < 0.001) compared with the Lichtenstein technique. CONCLUSION: For a selected group of patients the Shouldice technique can be used for primary unilateral inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and TAPP operations.

A post-market, prospective, multi-center, single-arm clinical investigation of Phasix™ mesh for VHWG grade 3 midline incisional hernia repair: a research protocol.

BACKGROUND: Incisional heia is a frequent complication of midline laparotomy. The use of mesh in hernia repair has been reported to lead to fewer recurrences compared to primary repair. However, in Ventral Hernia Working Group (VHWG) Grade 3 hernia patients, whose hernia is potentially contaminated, synthetic mesh is prone to infection. There is a strong preference for resorbable biological mesh in contaminated fields, since it is more able to resist infection, and because it is fully resorbed, the chance of a foreign body reaction is reduced. However, when not crosslinked, biological resorbable mesh products tend to degrade too quickly to facilitate native cellular ingrowth. Phasix™ Mesh is a biosynthetic mesh with both the biocompatibility and resorbability of a biological mesh and the mechanical strength of a synthetic mesh. This multi-center single-arm study aims to collect data on safety and performance of Phasix™ Mesh in Grade 3 hernia patients. METHODS: A total of 85 VHWG Grade 3 hernia patients will be treated with Phasix™ Mesh in 15 sites across Europe. The primary outcome is Surgical Site Occurrence (SSO) including hematoma, seroma, infection, dehiscence and fistula formation (requiring intervention) through 3 months. Secondary outcomes include recurrence, infection and quality of life related outcomes after 24 months. Follow-up visits will be at drain removal (if drains were not placed, then on discharge or staple removal instead) and in the 1st, 3rd, 6th, 12th, 18th and 24th month after surgery. CONCLUSION: Based on evidence from this clinical study Depending on the results this clinical study will yield, Phasix™ Mesh may become a preferred treatment option in VHWG Grade 3 patients. TRIAL REGISTRATION: The trial was registered on March 25, 2016 on clinicaltrials.gov: NCT02720042 .

Does surgeon volume matter in the outcome of endoscopic inguinal hernia repair?

INTRODUCTION: For open and endoscopic inguinal hernia surgery, it has been demonstrated that low-volume surgeons with fewer than 25 and 30 procedures, respectively, per year are associated with significantly more recurrences than high-volume surgeons with 25 and 30 or more procedures, respectively, per year. This paper now explores the relationship between the caseload and the outcome based on the data from the Herniamed Registry. PATIENTS AND METHODS: The prospective data of patients in the Herniamed Registry were analyzed using the inclusion criteria minimum age of 16 years, male patient, primary unilateral inguinal hernia, TEP or TAPP techniques and availability of data on 1-year follow-up. In total, 16,290 patients were enrolled between September 1, 2009, and February 1, 2014. Of the participating surgeons, 466 (87.6 %) had carried out fewer than 25 endoscopic/laparoscopic operations (low-volume surgeons) and 66 (12.4 %) surgeons 25 or more operations (high-volume surgeons) per year. RESULTS: Univariable (1.03 vs. 0.73 %; p = 0.047) and multivariable analysis [OR 1.494 (1.065-2.115); p = 0.023] revealed that low-volume surgeons had a significantly higher recurrence rate compared with the high-volume surgeons, although that difference was small. Multivariable analysis also showed that pain on exertion was negatively affected by a lower caseload <25 [OR 1.191 (1.062-1.337); p = 0.003]. While here, too, the difference was small, the fact that in that group there was a greater proportion of patients with small hernia defect sizes may have also played a role since the risk in that group was higher. In this analysis, no evidence was found that pain at rest [OR 1.052 (0.903-1.226); p = 0.516] or chronic pain requiring treatment [OR 1.108 (0.903-1.361); p = 0.326] were influenced by the surgeon volume. As confirmed by previously published studies, the data in the Herniamed Registry also demonstrated that the endoscopic/laparoscopic inguinal hernia surgery caseload impacted the outcome. However, given the overall high-quality level the differences between a "low-volume" surgeon and a "high-volume" surgeon were small. That was due to the use of a standardized technique, structured training as well as continuous supervision of trainees and surgeons with low annual caseload.

What are the differences in the outcome of laparoscopic axial (I) versus paraesophageal (II-IV) hiatal hernia repair?

INTRODUCTION: Comparison of elective laparoscopic repair of axial vs paraesophageal hiatal hernias reveals relevant differences in both the patient collectives and the complexity of the procedures. MATERIALS AND METHODS: The present uni- and multivariable analysis of data from the Herniamed Registry compares the outcome for 2047 (67.3%) (type I) axial with 996 (32.7%) (types II-IV) paraesophageal primary hiatal hernias following laparoscopic repair. RESULTS: Compared with the patients with axial hiatal hernias, patients with paraesophageal hiatal hernia were nine years older, had a higher ASA score (ASA III/IV: 34.8 vs 13.7%; p < 0.001), and more often at least one risk factor (38.8 vs 21.4%; p < 0.001). This led in the univariable analysis to significantly more general postoperative complications (6.0 vs 3.0%; p < 0.001). Reflecting the greater complexity of the procedures used for laparoscopic repair of paraesophageal hiatal hernias, significantly higher intraoperative organ injury rates (3.7 vs 2.3%; p = 0.033) and higher postoperative complication-related reoperation rates (2.1 vs 1.1%; p = 0.032) were identified. Univariable analysis did not reveal any significant differences in the recurrence and pain rates on one-year follow-up. Multivariable analysis did not find any evidence that the use of a mesh had a significant influence on the recurrence rate. CONCLUSION: Surgical repair of paraesophageal hiatal hernia calls for an experienced surgeon as well as for corresponding intensive medicine competence because of the higher risks of general and surgical postoperative complications.

TEP or TAPP for recurrent inguinal hernia repair-register-based comparison of the outcome.

INTRODUCTION: The guidelines of the international hernia societies recommend laparo-endoscopic inguinal hernia repair for recurrent hernias after open primary repair. To date, no randomized trials have been conducted to compare the TEP vs TAPP outcome for recurrent inguinal hernia repair. A Swiss registry study identified only minor differences between the two techniques, thus suggesting the equivalence of the two procedures. MATERIALS AND METHODS: Between September 1, 2009 and August 31, 2013 data were entered into the Herniamed Registry on a total of 2246 patients with recurrent inguinal hernia repair following previous open primary operation in either TAPP (n = 1,464) or TEP technique (n = 782). RESULTS: Univariable and multivariable analysis did not find any significant difference between TEP and TAPP with regard to the intraoperative complications, complication-related reoperations, re-recurrences, pain at rest, pain on exertion, or chronic pain requiring treatment. The only difference identified was a significantly higher postoperative seroma rate after TAPP, which was influenced by the surgical technique, previous open primary operation and EHS-classification medial and responded to conservative treatment. CONCLUSION: TEP and TAPP are equivalent surgical techniques for recurrent inguinal hernia repair following previous open primary operation. The choice of technique should be tailored to the surgeon's expertise.

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.

TEP versus Lichtenstein: Which technique is better for the repair of primary unilateral inguinal hernias in men?

INTRODUCTION: In the update of the guidelines of the European Hernia Society, open Lichtenstein and endoscopic techniques continue to be recommended as the surgical technique of choice for repair of unilateral primary inguinal hernias in men despite the fact that a meta-analysis had identified a higher recurrence rate for TEP compared with Lichtenstein operation. The Guidelines Group had taken that decision because one surgeon in one of the randomized controlled trials included in the meta-analysis had had a very high recurrence rate. Therefore, this study based on registry data now compares the outcome of TEP versus Lichtenstein repair. PATIENTS AND METHODS: The analysis of the Herniamed Registry compares the prospective data collected for male patients undergoing primary unilateral inguinal hernia repair using either TEP or open Lichtenstein repair. Inclusion criteria were minimum age of 16 years, male patient, primary unilateral inguinal hernia, elective operation, and availability of data on 1-year follow-up. In total, 17,388 patients were enrolled between September 1, 2009, and August 31, 2013. Of these patients, 10,555 (60.70 %) had a Lichtenstein repair and 6833 (39.30 %) a TEP repair. RESULTS: On multivariable analysis, the surgical technique was not found to have had any significant effect on the recurrence rate (p = 0.146) or on the chronic pain rate (p = 0.560). Nor did the complication-related reoperation rates differ significantly between the two techniques (p = 0.084). But TEP was found to have benefits as regards the postoperative complication rate (p < 0.001), pain at rest rate (p = 0.011), and pain on exertion rate (p < 0.001). In the present registry study, no significant difference was identified in the recurrence rates between the TEP and Lichtenstein technique. TEP was found to have benefits compared with Lichtenstein repair as regards the postoperative complication rates, pain at rest, and pain on exertion.

Has endoscopic (TEP, TAPP) or open inguinal hernia repair a higher risk of bleeding in patients with coagulopathy or antithrombotic therapy? Data from the Herniamed Registry.

INTRODUCTION: Inguinal hernia operations in the presence of antithrombotic therapy, based on antiplatelet or anticoagulant drugs, or existing coagulopathy are associated with a markedly higher risk for onset of postoperative secondary bleeding. To date, there is a paucity of concrete data on this important clinical aspect of inguinal hernia surgery. Up till now, the endoscopic (TEP, TAPP) techniques have been considered to be more risky because of the extensive dissection involved. PATIENTS AND METHODS: Out of the 82,911 patients featured in the Herniamed Hernia Registry who had undergone inguinal hernia repair, 9115 (11 %) were operated on while receiving antithrombotic therapy or with existing coagulopathy. The implications of that risk profile for onset of postoperative bleeding were investigated in multivariable analysis. In addition, other influence variables were identified. RESULTS: The rate of postoperative secondary bleeding, at 3.91 %, was significantly higher in the risk group with coagulopathy or receiving antithrombotic therapy than in the group without that risk profile at 1.12 % (p < 0.001). Multivariable analysis revealed other influence variables which, in addition to coagulopathy or antithrombotic therapy, had a relevant influence on the occurrence of postoperative bleeding. These were open operation, a higher age, a higher ASA score, recurrence, male gender and a large hernia defect. Patients receiving antithrombotic therapy or with existing coagulopathy who undergo inguinal hernia operation have a fourfold higher risk for onset of postoperative secondary bleeding. Despite the extensive dissection required for endoscopic (TEP, TAPP) inguinal hernia repair, the risk of bleeding complications and complication-related reoperation appears to be lower.

Endoscopic repair of primary versus recurrent male unilateral inguinal hernias: Are there differences in the outcome?

INTRODUCTION: To date, there are no prospective randomized studies that compare the outcome of endoscopic repair of primary versus recurrent inguinal hernias. It is therefore now attempted to answer that key question on the basis of registry data. PATIENTS AND METHODS: In total, 20,624 patients were enrolled between September 1, 2009, and April 31, 2013. Of these patients, 18,142 (88.0%) had a primary and 2482 (12.0%) had a recurrent endoscopic repair. Only patients with male unilateral inguinal hernia and with a 1-year follow-up were included. The dependent variables were intra- and postoperative complications, reoperations, recurrence, and chronic pain rates. The results of unadjusted analyses were verified via multivariable analyses. RESULTS: Unadjusted analysis did not reveal any significant differences in the intraoperative complications (1.28 vs 1.33%; p = 0.849); however, there were significant differences in the postoperative complications (3.20 vs 4.03%; p = 0.036), the reoperation rate due to complications (0.84 vs 1.33%; p = 0.023), pain at rest (4.08 vs 6.16%; p < 0.001), pain on exertion (8.03 vs 11.44%; p < 0.001), chronic pain requiring treatment (2.31 vs 3.83%; p < 0.001), and the recurrence rates (0.94 vs 1.45%; p = 0.0023). Multivariable analysis confirmed the significant impact of endoscopic repair of recurrent hernia on the outcome. CONCLUSION: Comparison of perioperative and 1-year outcome for endoscopic repair of primary versus recurrent male unilateral inguinal hernia showed significant differences to the disadvantage of the recurrent operation. Therefore, endoscopic repair of recurrent inguinal hernias calls for particular competence on the part of the hernia surgeon.

Is the age of >65 years a risk factor for endoscopic treatment of primary inguinal hernia? Analysis of 24,571 patients from the Herniamed Registry.

INTRODUCTION: Several analyses of hernia registries have demonstrated that patients older than 65 years have significantly higher perioperative complication rates compared with patients up to the age of 65. To date, no special analyses of endoscopic/laparoscopic inguinal hernia surgery or of the relevant additional influence factors have been carried out. Besides, there is no definition to determine whether 65 years should really be considered to be the age limit. METHODS: In the Herniamed Hernia Registry, it was possible to identify 24,571 patients with a primary inguinal hernia and aged at least 16 years who had been operated on between September 1, 2009, and April 15, 2013, using either the TAPP technique (n = 17,214) or TEP technique (n = 7,357). Patients in the age group up to and including 65 years (≤65 years) were compared with those older than 65 years (>65 years) in terms of their perioperative outcome. That was done first using unadjusted analysis and then multivariable analysis. RESULTS: Unadjusted analysis revealed significantly different results for the intraoperative (1.19 vs 1.60%; p = 0,010), postoperative surgical (2.72 vs 4.59%; p < 0.001) and postoperative general complications (0.85 vs 1.98%; p < 0.001) as well as for complication-related reoperations (1.07 vs 1.37%; p = 0,044), which were more favorable in the ≤65 years age group. However, in multivariable analysis, it was not possible to confirm that for the intraoperative complications or the reoperations. Reoperations were needed more often for bilateral procedures (p < 0.001; OR 2.154 [1.699; 2.730]), higher ASA classification (IV vs I: p = 0.004; OR 6.001 [1.786; 20.167]), larger hernia defect and scrotal hernias. The impact of these factors, in addition to that of age >65 years, was also reflected in the postoperative complication rates. The age limit for increased onset of perioperative complication rates tends to be more than 80 rather than 65 years. CONCLUSION: The higher perioperative complication rate associated with endoscopic/laparoscopic inguinal hernia surgery in patients older than 65 years is of multifactorial genesis and is observed in particular as from the age of 80 years.

When is mesh fixation in TAPP-repair of primary inguinal hernia repair necessary? The register-based analysis of 11,230 cases.

Whereas for TEP the guidelines do not recommend mesh fixation on the basis of meta-analyses regardless of the defect size, for TAPP mesh fixation can be omitted only up to a defect size of 3 cm because of the paucity of studies on this topic. Hence, this study now seeks to explore this subject on the basis of prospective data from the Herniamed Hernia Registry. In the period September 01, 2009, to January 31, 2014, 11,228 male patients were operated on with the TAPP technique for a primary unilateral inguinal hernia and were followed up for 1 year. Mesh fixation was used for 7422 (66.1 %) of these patients and no mesh fixation for 3806 patients (33.9 %). Unadjusted analysis did not find any significant difference in the recurrence rate (0.88 % with fixation vs. 1.1 % without fixation; p = 0.259). Multivariable analysis of all potential influence factors (age, ASA, BMI, risk factors, defect size, mesh fixation, localization of defect, mesh size) did not identify any factor that impacted recurrence on 1-year follow-up. Only for medial and combined defect localization versus lateral localization was a highly significant effect identified (p < 0.001). With mesh fixation and larger mesh size, it was possible to significantly reduce the recurrence rate for larger medial hernias in this series (p = 0.046). For TAPP repair of an inguinal hernia, mesh fixation is not necessary in a significant number of patients. Patients with a medial and combined hernia are at higher risk of recurrence. In the patient series analyzed, it was possible to significantly reduce the recurrence rate with mesh fixation and larger mesh size for medial defects.

Open Repair of Primary Versus Recurrent Male Unilateral Inguinal Hernias: Perioperative Complications and 1-Year Follow-up.

INTRODUCTION: The recommendation in the European Hernia Society Guidelines for the treatment of recurrent inguinal hernias is to modify the technique in relation to the previous technique, and use a new plane of dissection for mesh implantation. However, the registry data show that even following previous open suture and mesh repair to treat a primary inguinal hernia, open suture and mesh repair can be used once again for a recurrent hernia. It is therefore important to know what the outcome of open repair of recurrent inguinal hernias is compared with open repair of primary inguinal hernias, while taking the previous operation into account. PATIENTS AND METHODS: In the Herniamed Registry, a total of 17,594 patients with an open primary or recurrent unilateral inguinal hernia repair in men with a 1-year follow-up were prospectively documented between September 1, 2009 and August 31, 2013. Of these patients, 15,274 (86.8 %) had an open primary and 2320 (13.2 %) open recurrent repair. In the unadjusted and multivariable analyses, the dependent variables were intra- and postoperative complications, reoperations, recurrences, pain at rest, pain on exertion, and pain requiring treatment. RESULTS: Open recurrent repair compared with the open primary operation is a significant influence factor for higher intraoperative (p = 0.01) and postoperative (p = 0.05) complication rates, recurrence rate (p < 0.001), and pain rates (p < 0.001). With regard to repair of recurrent inguinal hernia, previous open mesh repair was associated with the least favorable outcome, and with the highest odds ratio, for all outcome criteria. Open recurrent repair following previous endoscopic operation presented the least risk for postoperative complications, complication-related reoperations, and re-recurrences. The pain rates identified on follow-up after open recurrent repair were lower following previous open suture operation compared with following open and endoscopic mesh repair. A significantly less favorable perioperative and 1-year follow-up outcome must be expected for open repair of recurrent inguinal hernia in comparison with open primary inguinal hernia repair. After open recurrent repair, the most favorable perioperative complication and recurrence rates were identified following previous endoscopic repair, and the lowest pain rates following previous open suture repair. Open recurrent repair following previous open mesh operation was associated with the highest risks for perioperative complications, re-recurrences, and pain.