META Score: An International Consensus Scoring System on Mesh-Tissue Adhesions.

BACKGROUND: Currently, the lack of consensus on postoperative mesh-tissue adhesion scoring leads to incomparable scientific results. The aim of this study was to develop an adhesion score recognized by experts in the field of hernia surgery. METHODS: Authors of three or more previously published articles on both mesh-tissue adhesion scores and postoperative adhesions were marked as experts. They were queried on seven items using a modified Delphi method. The items concerned the utility of adhesion scoring models, the appropriateness of macroscopic and microscopic variables, the range and use of composite scores or subscores, adhesion-related complications and follow-up length. This study comprised two questionnaire-based rounds and one consensus meeting. RESULTS: The first round was completed by 23 experts (82%), the second round by 18 experts (64%). Of those 18 experts, ten were able to participate in the final consensus meeting and all approved the final proposal. From a total of 158 items, consensus was reached on 90 items. The amount of mesh surface covered with adhesions, tenacity and thickness of adhesions and organ involvement was concluded to be a minimal set of variables to be communicated separately in each future study on mesh adhesions. CONCLUSION: The MEsh Tissue Adhesion scoring system is the first consensus-based scoring system with a wide backing of renowned experts and can be used to assess mesh-related adhesions. By including this minimal set of variables in future research interstudy comparability and objectivity can be increased and eventually linked to clinically relevant outcomes.

Meta-analysis on Materials and Techniques for Laparotomy Closure: The MATCH Review.

BACKGROUND: The aim of this systematic review and meta-analysis was to evaluate closure materials and suture techniques for emergency and elective laparotomies. The primary outcome was incisional hernia after 12 months, and the secondary outcomes were burst abdomen and surgical site infection. METHODS: A systematic literature search was conducted until September 2017. The quality of the RCTs was evaluated by at least 3 assessors using critical appraisal checklists. Meta-analyses were performed. RESULTS: A total of 23 RCTs were included in the meta-analysis. There was no evidence from RCTs using the same suture technique in both study arms that any suture material (fast-absorbable/slowly absorbable/non-absorbable) is superior in reducing incisional hernias. There is no evidence that continuous suturing is superior in reducing incisional hernias compared to interrupted suturing. When using a slowly absorbable suture for continuous suturing in elective midline closure, the small bites technique results in significantly less incisional hernias than a large bites technique (OR 0.41; 95% CI 0.19, 0.86). CONCLUSIONS: There is no high-quality evidence available concerning the best suture material or technique to reduce incisional hernia rate when closing a laparotomy. When using a slowly absorbable suture and a continuous suturing technique with small tissue bites, the incisional hernia rate is significantly reduced compared with a large bites technique.

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 .

Liquid antiadhesive agents for intraperitoneal hernia repair procedures: Artiss® compared to CoSeal® and Adept® in an IPOM rat model.

BACKGROUND: Adhesion formation remains an important issue in hernia surgery. Liquid agents were developed for easy and versatile application, especially in laparoscopy. The aim of this study was to compare the antiadhesive effect of fibrin sealant (FS, Artiss®), Icodextrin (ID, Adept®) and Polyethylene glycol (PEG, CoSeal®) alone and in combination and to evaluate the resulting effect on tissue integration of the mesh. METHODS: A total of 56 Sprague-Dawley rats were operated in open IPOM technique. A middleweight polypropylene mesh of 2 × 2 cm size was implanted and covered with 1: FS, 2: ID, 3: PEG, 4: FS + ID, 5: FS + PEG, 6: PEG + ID, 7: control group, uncovered mesh (n = 8 per treatment/control). Observation period was 30 days. Macroscopic and histological evaluation was performed. RESULTS: Severe adhesions were found in group 2 (ID), group 6 (PEG + ID) and the controls. Best results were achieved with FS alone or FS + ID. Mesh integration in the treatment groups was reduced in comparison with the control group. This is a new finding possibly relevant for the outcome of intraperitoneal mesh repair. Group 6 (PEG + ID) showed an impairment of tissue integration with <50 % of the mesh surface in seven samples. CONCLUSION: FS alone and in combination with ID yielded excellent adhesion prevention. ID alone did not show significant adhesion prevention after 30 days. Tissue integration of FS-covered meshes was superior to ID or PEG alone or combined. PEG did show adhesion prevention comparable to FS but evoked impaired tissue integration. So Artiss® is among the most potent antiadhesive agents in IPOM repair.

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.

Guidelines for laparoscopic treatment of ventral and incisional abdominal wall hernias (International Endohernia Society (IEHS)-part 1.

Guidelines are increasingly determining the decision process in day-to-day clinical work. Guidelines describe the current best possible standard in diagnostics and therapy. They should be developed by an international panel of experts, whereby alongside individual experience, above all, the results of comparative studies are decisive. According to the results of high-ranking scientific studies published in peer-reviewed journals, statements and recommendations are formulated, and these are graded strictly according to the criteria of evidence-based medicine. Guidelines can therefore be valuable in helping particularly the young surgeon in his or her day-to-day work to find the best decision for the patient when confronted with a wide and confusing range of options. However, even experienced surgeons benefit because by virtue of a heavy workload and commitment, they often find it difficult to keep up with the ever-increasing published literature. All guidelines require regular updating, usually every 3 years, in line with progress in the field. The current Guidelines focus on technique and perioperative management of laparoscopic ventral hernia repair and constitute the first comprehensive guidelines on this topic. In this issue of Surgical Endoscopy, the first part of the Guidelines is published including sections on basics, indication for surgery, perioperative management, and key points of technique. The next part (Part 2) of the Guidelines will address complications and comparisons between open and laparoscopic techniques. Part 3 will cover mesh technology, hernia prophylaxis, technique-related issues, new technologic developments, lumbar and other unusual hernias, and training/education.

[Incisional hernias: epidemiology, evidence and guidelines]. / Narbenhernien: Epidemiologie, Evidenz und Leitlinien.

BACKGROUND: From an epidemiological point of view, one third of the population in industrialized countries will undergo abdominal surgery during their lifetime. Depending on the degree of patient-related and procedure-related risks, the occurrence of incisional hernias is associated in a range of up to 30% at 2­year follow-up and even up to 60% at 5 years. In addition to influencing comorbidities, the type of surgical approach and closure technique are of critical importance. OBJECTIVE: To present a descriptive evidence-based recommendation for abdominal wall closure and prophylactic mesh augmentation. MATERIAL AND METHODS: A concise summary was prepared incorporating the current literature and existing guidelines. RESULTS: According to recent studies the recognized risk for the occurrence of incisional hernias in the presence of obesity and abdominal aortic diseases also applies to patients undergoing colorectal surgery and the presence of diastasis recti abdominis. Based on high-level published data, the short stitch technique for midline laparotomy in the elective setting has a high level of evidence to be a standard procedure. Patients with an increased risk profile should receive prophylactic mesh reinforcement, either onlay or sublay, in addition to the short stitch technique. In emergency laparotomy, the individual risk of infection with respect to the closure technique used must be included. CONCLUSION: The avoidance of incisional hernias is primarily achieved by the minimally invasive access for laparoscopy. For closure of the most commonly used midline approach, the short stitch technique and, in the case of existing risk factors, additionally mesh augmentation are recommended.

Long-term evaluation of the Hernia Compact course of the German Hernia School.

INTRODUCTION: Since 2011, the German Hernia Society has developed the German Hernia School (GHS) as a standardized hernia surgery training program for younger surgeons, consisting of the Hernia Compact basic module. It is a standardized three day training program (cadaver workshop, ultrasound simulation training, and hands-on training). After 12 years of experience, a survey was conducted to evaluate the long term effect of this training. METHOD: Using an anonymous online-questionnaire, we contacted from September 2023 to October 2023 the Hernia Compact course participants via the congress organizer "Weitmeer" and the German Hernia Society. This online questionnaire contains 18 multiple choice questions regarding participants' age, gender, professional experience, participation in other modules of the German Hernia School, the effect of the course on their daily practice and their specific interest in hernia and abdominal wall surgery. RESULTS: A total of 146 participants responded to the anonymous online questionnaire. A majority of 132 of 146 participants (90.42%) responded that this course improved the quality of surgical and hernia training (n = 146, no missing data). 141 of 146 individuals (96.58%) recommended the course to surgical colleagues (n = 146, no missing data). There were 89.73% of participants, (n = 146, no missing data) that developed a specific interest in hernia and abdominal wall surgery after the course. For 78.08% (n = 146, no missing data) of participants hernia and abdominal wall surgery was one of the most important activities in their daily surgical practice. CONCLUSION: The standardized Hernia Compact basic course of the German Hernia School appears to have a huge impact on the quality of hernia surgery training in Germany and Austria. It might also help generate a specific interest in hernia surgery among participants.

Three-year follow-up analysis of the short-stitch versus long-stitch technique for elective midline abdominal closure randomized-controlled (ESTOIH) trial.

BACKGROUND: Clinical trials have shown reduced incisional hernia rates 1 year after elective median laparotomy closure using a short-stitch technique. With hernia development continuing beyond the first postoperative year, we aimed to compare incisional hernias 3 years after midline closure using short or long stitches in patients from the ESTOIH trial. METHODS: The ESTOIH trial was a prospective, multicenter, parallel-group, double-blind, randomized-controlled study of primary elective midline closure. Patients were randomized to fascia closure using a short- or long-stitch technique with a poly-4-hydroxybutyrate-based suture. A predefined 3-year follow-up analysis was performed with the radiological imaging-verified incisional hernia rate as the primary endpoint. RESULTS: The 3-year intention-to-treat follow-up cohort consisted of 414 patients (210 short-stitch and 204 long-stitch technique) for analysis. Compared with 1 year postoperatively, incisional hernias increased from 4.83% (20/414 patients) to 9.02% (36/399 patients, p = 0.0183). The difference between the treatment groups at 3 years (short vs. long stitches, 15/198 patients (7.58%) vs. 21/201 (10.45%)) was not significant (OR, 1.4233; 95% CI [0.7112-2.8485]; p = 0.31). CONCLUSION: Hernia rates increased significantly between one and 3 years postoperatively. The short-stitch technique using a poly-4-hydroxybutyrate-based suture is safe in the long term, while no significant advantage was found at 3 years postoperatively compared with the standard long-stitch technique. TRIAL REGISTRY: NCT01965249, registered on 18 October 2013.

The impact of atraumatic fibrin sealant vs. staple mesh fixation in TAPP hernia repair on chronic pain and quality of life: results of a randomized controlled study.

BACKGROUND: Mesh reinforcement has become the standard of care in the open and laparoscopic repair of inguinal hernia. Chronic pain after inguinal hernia repair is often due to nerve injury by penetrating mesh fixation devices such as staples (ST), tacks, or sutures. In several studies on hernioplasty, atraumatic mesh fixation with fibrin sealant (FS) proved to be efficient in terms of fixation strength and elasticity. Unfortunately, most of these studies did not provide a standardized follow-up and assessment of the development of chronic pain (CP) and the quality of life (QoL). Therefore, a randomized controlled trial comparing CP and QoL after FS fixation of mesh with ST in transabdominal preperitoneal hernioplasty (TAPP) was performed at our department. The primary end point of our study was to assess the patient outcome by using a visual analog scale (VAS) and the short form 36 (SF-36). The evaluation of recurrence rates was the secondary aim. METHODS: According to the randomization, a macroporous mesh (TiMESH(®)) was fixed in group A (44 patients with 54 inguinal hernias) with FS (TISSEEL) or in group B (45 patients with 56 inguinal hernias) with ST (EMS(®) Stapler). The observation period was 1 year with regular clinical check ups and assessment of VAS and SF-36. RESULTS: Patient characteristics expressed by BMI, ASA scores, and Schumpelick hernia classification were similar in both treatment groups. In each group there was one recurrence within 8 (FS) and 9 months (ST) postsurgery. The mean preoperative pain values scored by VAS were 1.7 (range = 0-7.5) in the FS group and 2.2 (range = 0-6) in the ST group. Postoperative mean VAS scores measured at 1 year postsurgery were 0.4 (range = 0-3) in the FS group and 0.9 (range = 0-7.5) in the ST group. One year postsurgery there was no significant difference between the two groups with respect to the parameter pain in the SF-36 and VAS. CONCLUSION: Fibrin sealant fixation leads to a low rate of hernia recurrence and avoids tissue trauma. ST provide similar results in the hand of the expert but bear inherent risks of complications due to tissue perforation.

Factors influencing the fascial closure rate after open abdomen treatment: Results from the European Hernia Society (EuraHS) Registry : Surgical technique matters.

PURPOSE: Definitive fascial closure is an essential treatment objective after open abdomen treatment and mitigates morbidity and mortality. There is a paucity of evidence on factors that promote or prevent definitive fascial closure. METHODS: A multi-center multivariable analysis of data from the Open Abdomen Route of the European Hernia Society included all cases between 1 May 2015 and 31 December 2019. Different treatment elements, i.e. the use of a visceral protective layer, negative-pressure wound therapy and dynamic closure techniques, as well as patient characteristics were included in the multivariable analysis. The study was registered in the International Clinical Trials Registry Platform via the German Registry for Clinical Trials (DRK00021719). RESULTS: Data were included from 630 patients from eleven surgical departments in six European countries. Indications for OAT were peritonitis (46%), abdominal compartment syndrome (20.5%), burst abdomen (11.3%), abdominal trauma (9%), and other conditions (13.2%). The overall definitive fascial closure rate was 57.5% in the intention-to-treat analysis and 71% in the per-protocol analysis. The multivariable analysis showed a positive correlation of negative-pressure wound therapy (odds ratio: 2.496, p < 0.001) and dynamic closure techniques (odds ratio: 2.687, p < 0.001) with fascial closure and a negative correlation of intra-abdominal contamination (odds ratio: 0.630, p = 0.029) and the number of surgical procedures before OAT (odds ratio: 0.740, p = 0.005) with DFC. CONCLUSION: The clinical course and prognosis of open abdomen treatment can significantly be improved by the use of treatment elements such as negative-pressure wound therapy and dynamic closure techniques, which are associated with definitive fascial closure.

Effects of the short-stitch technique for midline abdominal closure: short-term results from the randomised-controlled ESTOIH trial.

PURPOSE: The short-stitch technique for midline laparotomy closure has been shown to reduce hernia rates, but long stitches remain the standard of care and the effect of the short-stitch technique on short-term results is not well known. The aim of this study was to compare the two techniques, using an ultra-long-term absorbable elastic suture material. METHODS: Following elective midline laparotomy, 425 patients in 9 centres were randomised to receive wound closure using the short-stitch (USP 2-0 single thread, n = 215) or long-stitch (USP 1 double loop, n = 210) technique with a poly-4-hydroxybutyrate-based suture material (Monomax®). Here, we report short-term surgical outcomes. RESULTS: At 30 (+10) days postoperatively, 3 (1.40%) of 215 patients in the short-stitch group and 10 (4.76%) of 210 patients in the long-stitch group had developed burst abdomen [OR 0.2830 (0.0768-1.0433), p = 0.0513]. Ruptured suture, seroma and hematoma and other wound healing disorders occurred in small numbers without differences between groups. In a planned Cox proportional hazard model for burst abdomen, the short-stitch group had a significantly lower risk [HR 0.1783 (0.0379-0.6617), p = 0.0115]. CONCLUSIONS: Although this trial revealed no significant difference in short-term results between the short-stitch and long-stitch techniques for closure of midline laparotomy, a trend towards a lower rate of burst abdomen in the short-stitch group suggests a possible advantage of the short-stitch technique. TRIAL REGISTRY: NCT01965249, registered October 18, 2013.

Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair.

INTRODUCTION: Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. METHODS: A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. RESULTS: Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. CONCLUSION: After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. TRIAL REGISTRATION: Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.

Comparison of three separate antiadhesive barriers for intraperitoneal onlay mesh hernia repair in an experimental model.

BACKGROUND: Adhesion formation is a common adverse effect in intraperitoneal onlay mesh (IPOM) surgery. Different methods of adhesion prevention have been developed, including coated meshes and separate antiadhesive barriers (SABs). In this study one type of mesh was tested with different SABs, which were fixed to the sutured mesh using fibrin sealant. The primary aim was to compare adhesion prevention between different SABs. Secondary aims were the assessment of tissue integration and evaluation of SAB fixation with fibrin sealant. METHODS: Thirty-two rats were randomized to one of three treatment groups (SurgiWrap, Prevadh and Seprafilm) or a control group (no SAB). Animals were operated on with an open IPOM technique (8 per group). One macroporous polypropylene mesh per animal (2 × 2 cm) was fixed with four non-absorbable sutures. An antiadhesive barrier of 2·5 × 2·5 cm was fixed with fibrin sealant. After 30 days, adhesion formation, tissue integration, seroma formation, inflammation and vascularization were evaluated macroscopically and by histology. RESULTS: Prevadh and Seprafilm groups showed a significant reduction in adhesion formation compared with the control group. Tissue integration of the mesh was reduced in these groups. Fibrin sealant fixed the SAB to the mesh securely in all groups. CONCLUSION: Prevadh and Seprafilm are potent materials for the reduction of adhesion formation. A potential relationship between effective adhesion prevention and impaired tissue integration of the implant was observed. Fibrin sealant proved an excellent agent for SAB fixation.

Human vital amniotic membrane reduces adhesions in experimental intraperitoneal onlay mesh repair.

BACKGROUND: Various antiadhesive coatings have been proposed for intraperitoneal onlay meshes (IPOM). However, adhesions, mesh infections, and impaired integration remain clinically relevant problems. In this experiment, human vital amniotic membrane (AM) was tested as antiadhesive mesh coating. Vital AM complies with clinical standards of product safety. METHODS: In this study, 24 rats were randomized to one control or two treatment groups (n=8). An uncoated polypropylene mesh (Vitamesh) was implanted using open IPOM technique and fixed with four sutures. In the treatment groups, vital AM was attached to Vitamesh by fibrin sealant fixation. The observation period was 7 and 17 days. Vitamesh fixed by suture only served as the control condition (17 days). Adhesion formation, tissue integration, and neovascularization were assessed macroscopically and histologically. RESULTS: All the meshes in the control group elicited severe adhesions. Vital AM was highly efficient in reducing adhesions to mesh and sutures. No foreign body reaction or unfavorable immunologic response to vital AM occurred. Tissue integration and neovascularization of coated meshes were good. Fibrin sealant yielded a reliable fixation. CONCLUSION: Human vital AM was highly effective in reducing adhesions to polypropylene mesh and sutures in experimental IPOM. No adverse effects were detected, and tissue integration of the mesh was good.

Biologic hernia implants in experimental intraperitoneal onlay mesh plasty repair: the impact of proprietary collagen processing methods and fibrin sealant application on tissue integration.

BACKGROUND: Biologic implants have been recommended for reinforcement in routine and challenging hernia repair. However, experimental and clinical studies have reported adverse effects (e.g., slow implant integration and pronounced foreign body reaction). To evaluate the impact of different material processing methods (cross-linking vs. non-cross-linking of collagen) and implant design, four different biologic hernia implants were compared directly in experimental intraperitoneal onlay mesh plasty (IPOM). Tissue integration, shrinkage, and foreign body reaction were primary outcome parameters. METHODS: In this study, 48 Sprague-Dawley rats were randomized to four treatment groups. Open IPOM repair was performed. One peritoneal defect per animal was covered with 2 × 2 cm patches of cross-linked or non-cross-linked implants including CollaMend (n = 12), Peripatch (n = 12), Surgisis (n = 12), and Tutomesh (n = 12). In half of the animals, fibrin sealant was applied for additional fixation and to cover sutures. The observation period was 60 days. The primary outcome parameters were implant integration, shrinkage, and foreign body reaction. Macroscopic and histologic assessments were performed. RESULTS: The integration of implants was insufficient in all the groups. The implants could be detached easily from the underlying tissue, and the penetration of fibroblasts and vessels was limited to the perforations. Foreign body reaction was pronounced with CollaMend and Surgisis, leading to persistent granulomatous inflammation. Shrinkage was excessive with Surgisis, whereas Tutomesh and Peripatch yielded sufficient anti-adhesion and elicited no foreign body reaction. CONCLUSION: At 2 months, cross-linked and non-cross-linked biologic hernia implants were poorly integrated. Cross-linking led to a more pronounced foreign body reaction. Less inflammatory response may reduce local complications, but did not enhance implant integration in this study.

Adverse effects of polyvinylidene fluoride-coated polypropylene mesh used for laparoscopic intraperitoneal onlay repair of incisional hernia.

BACKGROUND: Polyvinylidene fluoride-coated polypropylene meshes have been developed specifically for intraperitoneal onlay mesh repair. They combine a macroporous design with biomechanical characteristics compatible with the abdominal wall and are reported to have favourable antiadhesive properties. This retrospective study reports complications related to one of these materials, DynaMesh. METHODS: Twenty-nine patients underwent intraperitoneal onlay mesh repair with DynaMesh at one of two hospitals. Patients characteristics, surgical procedures and postoperative analgesia were comparable at both sites. RESULTS: Six patients developed DynaMesh-related complications that required surgical reintervention by laparotomy within 1 year of operation. Surgical reintervention was for adhesions in five patients and the mesh had to be explanted in three. One mesh was explanted because of early infection. Adhesions to DynaMesh were found in two patients who had surgery for unrelated reasons. CONCLUSION: Laparoscopic intraperitoneal onlay DynaMesh repair was associated with a high rate of complications.

A comparison of a bovine albumin/glutaraldehyde glue versus fibrin sealant for hernia mesh fixation in experimental onlay and IPOM repair in rats.

BACKGROUND: Research in hernia repair has targeted new atraumatic mesh fixation to reduce major complications such as chronic pain and adhesion formation. The efficacy and safety of two surgical adhesives, viz. Artiss® (FS, fibrin sealant containing 4 IU thrombin) and Bioglue® (AGG, bovine serum albumin/glutaraldehyde glue), were evaluated in this study. Primary study endpoints were tissue integration, dislocation, and adhesion formation. Foreign-body reaction formed the secondary study endpoint. METHODS: Twenty-four polypropylene meshes (VM, Vitamesh®) were randomized to four groups (n = 6): two groups of onlay hernia repair (two meshes per animal) with mesh fixation by FS (O-FS) or by AGG (O-AGG), and two groups of IPOM repair (one mesh per animal) with mesh fixation by four sutures and FS (I-FS) or AGG (I-AGG). Eighteen rats underwent surgery. Follow-up was 30 days. Tissue integration, dislocation, seroma formation, inflammation, adhesion formation, and foreign-body reaction were assessed. RESULTS: Meshes fixed with FS (O-FS, I-FS) showed good tissue integration. No dislocation, seroma formation, or macroscopic signs of inflammation were detectable. Adhesion formation of I-FS was significantly milder compared with I-AGG (P = 0.024). A moderate foreign-body reaction without active inflammation was seen histologically in O-FS and I-FS groups. Samples fixed with AGG (O-AGG, I-AGG) showed extensive scar formation. No dislocation and no seroma formation were observed. All of these samples showed moderate to severe signs of inflammation with abscess formation in the six meshes of O-AGG. Histology underlined these findings. CONCLUSIONS: The fibrin sealant adhesive showed very good overall results of the primary and secondary outcome parameters. FS is a recommendable atraumatic fixation tool for the surgical onlay technique. AGG provides high adhesive strength, but shows low biocompatibility. Persisting active inflammation was seen in both the O-AGG and I-AGG groups, not favoring its use for these indications.