Is mesh pore size in polypropylene meshes associated with the outcome in Lichtenstein inguinal hernia repair: a registry-based analysis of 22,141 patients.

INTRODUCTION: Experimental data show that large-pored meshes reduce foreign body reaction, inflammation and scar bridging and thus improve mesh integration. However, clinical data on the effect of mesh porosity on the outcome of hernioplasty are limited. This study investigated the relation of pore size in polypropylene meshes to the outcome of Lichtenstein inguinal hernioplasty using data from the Herniamed registry. METHODS: This analysis of data from the Herniamed registry evaluated perioperative and 1-year follow-up outcomes in patients undergoing elective, primary, unilateral Lichtenstein inguinal hernia repair using polypropylene meshes. Patients operated with a non-polypropylene mesh or a polypropylene mesh with absorbable components were excluded. Polypropylene meshes with a pore size of 1.0 × 1.0 mm or less were defined as small-pored meshes, while a pore size of more than 1.0 × 1.0 mm was considered large-pored. Unadjusted analyses and multivariable analyses were performed to investigate the relation of pore size of polypropylene meshes, patient and surgical characteristics to the outcome parameters. RESULTS: Data from 22,141 patients were analyzed, of which 6853 (31%) were operated on with a small-pore polypropylene mesh and 15,288 (69%) with a large-pore polypropylene mesh. No association of mesh pore size with intraoperative, general or postoperative complications, recurrence rate or pain requiring treatment was found at 1-year follow-up. A lower risk of complication-related reoperation tended to be associated with small-pore size (p = 0.086). Furthermore, small-pore mesh repair was associated with a lower risk of pain at rest and pain on exertion at 1-year follow-up. CONCLUSION: The present study could not demonstrate an advantage of large-pore polypropylene meshes for the outcome of Lichtenstein inguinal hernioplasty.

STRONGHOLD first-year results of biomechanically calculated abdominal wall repair: a propensity score matching.

PURPOSE: Every year around 70,000 people in Germany suffer from an abdominal incisional hernia that requires surgical treatment. Five years after reconstruction about 25% reoccur. Incisional hernias are usually closed with mesh using various reconstruction techniques, summarized here as standard reconstruction (SR). To improve hernia repair, we established a concept for biomechanically calculated reconstructions (BCR). In the BCR, two formulas enable customized patient care through standardized biomechanical measures. This study aims to compare the clinical outcomes of SR and BCR of incisional hernias after 1 year of follow-up based on the Herniamed registry. METHODS: SR includes open retromuscular mesh augmented incisional hernia repair according to clinical guidelines. BCR determines the required strength (Critical Resistance to Impacts related to Pressure = CRIP) preoperatively depending on the hernia size. It supports the surgeon in reliably determining the Gained Resistance, based on the mesh-defect-area-ratio, further mesh and suture factors, and the tissue stability. To compare SR and BCR repair outcomes in incisional hernias at 1 year, propensity score matching was performed on 15 variables. Included were 301 patients with BCR surgery and 23,220 with standard repair. RESULTS: BCR surgeries show a significant reduction in recurrences (1.7% vs. 5.2%, p = 0.0041), pain requiring treatment (4.1% vs. 12.0%, p = 0.001), and pain at rest (6.9% vs. 12.7%, p = 0.033) when comparing matched pairs. Complication rates, complication-related reoperations, and stress-related pain showed no systematic difference. CONCLUSION: Biomechanically calculated repairs improve patient care. BCR shows a significant reduction in recurrence rates, pain at rest, and pain requiring treatment at 1-year follow-up compared to SR.

Drain versus no drain in elective open incisional hernia operations: a registry-based analysis with 39,523 patients.

PURPOSE: Elective open incisional hernia operations are a frequently performed and complex procedure. Prophylactic drainage is widely practised to prevent local complications, but nevertheless the benefit of surgical drain placement remains a controversially discussed subject. Objective of this analysis was to evaluate the current status of patient care in clinical routine and outcome in this regard. METHODS: The study based on prospectively collected data of the Herniamed Register. Included were all patients with elective open incisional hernia between 1/2005 and 12/2020 and completed 1-year follow-up. Multiple linear and logistic regression analysis was performed to assess the relation of individual factors to the outcome variables. RESULTS: Analysed were data from 39,523 patients (28,182 with drain, 11,341 without). Patients with drain placement were significantly older, had a higher BMI, more preoperative risk factors, and a larger defect size. Drained patients furthermore showed a significant disadvantage in the outcome parameters intraoperative complications, general complications, postoperative complications, complication-related reoperations, and pain at the 1-year follow-up. No significant difference was observed with respect to the recurrent rate. CONCLUSION: With 71.3%, the use of surgical drainages has a high level of acceptance in elective open incisional hernia operations. The worse outcome of patients is associated with the use of drains, independent of other influencing factors in the model such as patient or surgical characteristics. The use of drains may be a surrogate parameter for other unobserved confounders.

One-stage versus two-stage Roux-Y gastric bypass as redo surgery of failed adjustable gastric banding.

INTRODUCTION: The study focussed on whether a one-stage Roux-Y gastric bypass (OS-RYGB) or a two-stage RYGB (TS-RYGB) has a significant advantage in terms of perioperative risk in patients after failed adjustable gastric banding (AGB). METHODS: Data collection included patients who underwent OS-RYGB or TS-RYGB after AGB between 2005 and 2019 and whose outcomes were compared with those after primary RYGB (P-RYGB). Outcome criteria were perioperative complications, comorbidities, 30-day mortality and operating time. RESULTS: The study analysed data from patients who underwent OS-RYGB (N = 525), TS-RYGB (N = 382) and P-RYGB (N = 26,445). Intraoperative and postoperative complication rates were significantly lower for P-RYGB (p < 0.001). Total intraoperative and specific postoperative complication rates were significantly lower in TS-RYGB than in OS-RYGB (p = 0.048 and p < 0.001, respectively). In contrast, the total general postoperative complication rate was lower in OS-RYGB than in TS-RYGB (p < 0.001). The mean operating time differed significantly among the three groups (P-RYGB 96.5min, OS-RYGB 141.2min and TS-RYGB 190.9min; p < 0.001). The mortality rate was not significantly different between the three groups. CONCLUSIONS: Based on the significant difference between the two groups in revision surgery and the slight difference with the results of primary RYGB, this study concludes that removal of a failed AGB is safe and feasible with either the OS- or TS-RYGB procedure. However, we cannot directly recommend either procedure in our study. Proper patient selection and surgeon experience are critical to avoid potential adverse effects.

Comparing routine administrative data with registry data for assessing quality of hospital care in patients with inguinal hernia.

INTRODUCTION: Collecting clinical data is viewed as the gold standard for assessing health-care quality. However, considerable investment is needed if the quality of care is to be recorded over a long period of time. Accordingly, the question arises as to whether routine administrative data may be used for quality assurance purposes if certain methodological standards are followed. This present study now compares the outcomes of inguinal hernia repair from the Herniamed Hernia Registry with routine data from Germany's largest sickness fund, the Local General Sickness Fund "AOK". MATERIALS AND METHODS: Included in the study were the hospital inpatient cases for the years 2011-2013 with inguinal hernia surgical repair whose data had been prospectively entered into the voluntary Herniamed Hernia Registry by 318 participating hospitals. These collectives were then compared, on the basis of the routine administrative data available, with patients from the AOK sickness fund who had been operated on during the same time period. The outcome criteria selected were the perioperative complication rates within 30 days as well as the recurrence rate and the pain rate requiring treatment at 1-year follow-up. RESULTS: The data records examined comprised 64,748 cases from the Herniamed Registry and 130,121 AOK cases. Since in the Herniamed collective, the proportion of bilateral procedures was significantly higher, only the collectives of elective primary unilateral inguinal hernias in men (Herniamed n = 37,667; AOK n = 78,973) were compared. The most pronounced difference between these two collectives was in the proportion of laparo-endoscopic procedures (Herniamed 61.3% vs AOK 49.0%; p < 0.001). Accordingly, the Herniamed collective was found to have a significantly lower postoperative surgical complication rate (Herniamed 1.5% vs AOK 2.6%; p < 0.001) and surgical site infection (SSI) rate (Herniamed 0.3% vs AOK 0.6%; p < 0.001) within 30 days after the operation. On the other hand, the pain rates requiring treatment in the Herniamed collective were somewhat higher (Herniamed 3.0% vs AOK 2.6%; p < 0.001). No difference was found in the recurrence rate at 1-year follow-up (Herniamed 1.0% vs AOK 0.9%; ns). CONCLUSION: Subject to critical evaluation of the limitations of data acquisition in this study, it does appear possible to use the routine administrative data from the AOK Sickness Fund for assessment of the quality of inguinal hernia surgery in Germany. Voluntary participation in the Herniamed Registry appears to be characterized by the fact that the participating hospitals conduct a higher proportion of laparo-endoscopic inguinal hernia repair. That could possibly explain the differences in outcome. However, in large patient collectives, statistical significance should not always be equated with clinical relevance. Univariate analysis does not take account of differences in the hernia findings, risk factors or operative details. Further efforts should be employed in future to improve the accuracy and granularity of routine administrative data for assessing the quality of care and to decrease the cost of gathering such data.

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.

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.

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.

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.

Prediction of response to tapentadol in chronic low back pain.

BACKGROUND: Many chronic low back pain (cLBP) patients do not satisfactorily respond to treatment. The knowledge of responders and non-responders before initiating treatment would improve decision making and reduce health care costs. The aims of this exploratory prediction study in cLBP patients treated with tapentadol were to identify predictors of treatment outcome based on baseline characteristics, to evaluate quality-of-life and functionality as alternative outcome parameters and to develop nomograms to calculate the individual probability of response. METHODS: In a retrospective analysis of an open-label phase 3b trial, 46 baseline characteristics were included into statistical prediction modelling. One hundred and twenty-one patients were followed up during the titration and treatment period and 67 patients were analysed who discontinued the trial. RESULTS: Demographic data were not relevant for response prediction. Nine baseline co-variables were robust: painDETECT score, intensity of burning and painful attacks, SF36 Health Survey score (MCS, PCS), EuroQol-5, Hospital Anxiety/Depression Scale. Gender had a minor influence. Alternative outcomes (quality-of-life, functionality) were more important for response prediction than conventional pain intensity measures. Neuropathic symptoms (high painDETECT score) had a positive predictive validity. Painful attacks and classical yellow flags (depression, anxiety) negatively influenced the treatment response. High depression scores, female gender and low burning predicted discontinuation during titration. CONCLUSION: In this exploratory study, predictive baseline characteristics have been identified that can be used to calculate the individual probability of tapentadol response in cLBP. The small sample size in relation to the number of initial variables is a limitation of this approach. SIGNIFICANCE: Predictors for treatment response of tapentadol were identified in patients with chronic low back pain based on clinical pre-treatment characteristics that can guide personalized treatment. Quality-of-life and functionality were the most relevant outcomes for response prediction.

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.

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.

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.