Prophylactic Use of Biologic Mesh in Ileal Conduit (PUBMIC): A Randomized Clinical Trial.

PURPOSE: We assessed the effect of prophylactic biologic mesh on parastomal hernia (PSH) development in patients undergoing cystectomy and ileal conduit (IC). MATERIALS AND METHODS: This phase 3, randomized, controlled trial (NCT02439060) included 146 patients who underwent cystectomy and IC at the University of Southern California between 2015 and 2021. Follow-ups were physical exam and CT every 4 to 6 months up to 2 years. Patients were randomized 1:1 to receive FlexHD prophylactic biological mesh using sublay intraperitoneal technique vs standard IC. The primary end point was time to radiological PSH, and secondary outcomes included clinical PSH with/without surgical intervention and mesh-related complications. RESULTS: The 2 arms were similar in terms of baseline clinical features. All surgeries and mesh placements were performed without any intraoperative complications. Median operative time was 31 minutes longer in patients who received mesh, yet with no statistically significant difference (363 vs 332 minutes, P = .16). With a median follow-up of 24 months, radiological and clinical PSHs were detected in 37 (18 mesh recipients vs 19 controls) and 16 (8 subjects in both arms) patients, with a median time to radiological and clinical PSH of 8.3 and 15.5 months, respectively. No definite mesh-related adverse events were reported. Five patients (3 in the mesh and 2 in the control arm) required surgical PSH repair. Radiological PSH-free survival rates in the mesh and control groups were 74% vs 75% at 1 year and 69% vs 62% at 2 years. CONCLUSIONS: Implementation of biologic mesh at the time of IC construction is safe without significant protective effects within 2 years following surgery.

Short-term outcomes of a multicentre prospective study using a "visible" polyvinylidene fluoride onlay mesh for the prevention of midline incisional hernia.

INTRODUCTION: Prophylactic meshes in high-risk patients prevent incisional hernias, although there are still some concerns about the best layer to place them in, the type of fixation, the mesh material, the significance of the level of contamination, and surgical complications. We aimed to provide answers to these questions and information about how the implanted material behaves based on its visibility under magnetic resonance imaging (MRI). METHOD: This is a prospective multicentre observational cohort study. Preliminary results from the first 3 months are presented. We included general surgical patients who had at least two risk factors for developing an incisional hernia. Multivariate logistic regression was used. A polyvinylidene fluoride (PVDF) mesh loaded with iron particles was used in an onlay position. MRIs were performed 6 weeks after treatment. RESULTS: Between July 2016 and June 2022, 185 patients were enrolled in the study. Surgery was emergent in 30.3% of cases, contaminated in 10.7% and dirty in 11.8%. A total of 5.6% of cases had postoperative wound infections, with the requirement of stoma being the only significant risk factor (OR = 7.59, p = 0.03). The formation of a seroma at 6 weeks detected by MRI, was associated with body mass index (OR = 1.13, p = 0.02). CONCLUSIONS: The prophylactic use of onlay PVDF mesh in midline laparotomies in high-risk patients was safe and effective in the short term, regardless of the type of surgery or the level of contamination. MRI allowed us to detect asymptomatic seromas during the early process of integration. STUDY REGISTRATION:  This protocol was registered at ClinicalTrials.gov (NCT03105895).

A Biomechanical Analysis of Prophylactic Mesh Reinforced Porcine Laparotomy Incisions.

INTRODUCTION: Research indicates that prophylactic mesh may help prevent incisional hernia after laparotomy, but best practice patterns in these situations are still evolving. Here, we compare the failure loads (FLs) and biomechanical stiffness (BMS) of 35 porcine abdominal wall laparotomy incisions reinforced with meshes of various widths and fixation distances using biomechanical testing. METHODS: In each specimen, a 10-cm incision was made and closed using continuous 1-0 Maxon suture. Specimens were randomized to mesh width (none, 2.5 cm, 3 cm, 4 cm, 6 cm, 8 cm) and tack separation (1.5 cm, 2 cm apart) and the meshes secured in an onlay fashion. Cyclic loads oscillating from 15 N to 140 N were applied to simulate abdominal wall stress, and the specimens subsequently loaded to failure. FLs (N) and BMS (N/mm) were comparatively analyzed. RESULTS: All specimens failed via suture pull-through. FLs and BMS were lowest in specimens with suture-only (421.43 N; 11.69 N/mm). FLs and BMS were significantly higher in 4-cm mesh specimens (567.51 N) than those with suture, 2.5-cm, and 3.0-cm mesh (all P < 0.05). FLs in specimens with a greater number of tacks were consistently higher in meshes of similar sizes, although these did not reach significance. CONCLUSIONS: A 4-cm mesh reenforcement was superior to suture-only and smaller meshes at preserving strength in laparotomy closure in a porcine model but larger meshes (6 cm, 8 cm) did not provide an additional benefit. Meshes with more fixation points may be advantageous, but additional data are needed to make definitive conclusions.

Prevention of Incisional Hernia after Open Hepato-Pancreato-Biliary Surgery: A Systematic Review.

INTRODUCTION: Most hepato-pancreato-biliary (HPB) procedures are still performed through open approach. Incisional hernia (IH) is one of the most common complications after open surgery. To date, published data on IH after HPB surgery are scarce; therefore, the aim of this study was to assess the current evidence regarding incidence, risk factors, and prevention. METHODS: Medline/PubMed (1946-2020), EMBASE (1947-2020), and the Cochrane library (1995-2020) were searched for studies on IH in open HPB surgery. Animal studies, editorials, letters, reviews, comments, short case series and liver transplant, laparoscopic, or robotic procedures were excluded. The protocol was registered with PROSPERO (CRD42020163296). RESULTS: A total of 5,079 articles were retrieved. Eight studies were finally included for the analysis. The incidence of IH after HPB surgery ranges from 7.7% to 38.8%. The identified risk factors were body mass index, surgical site infection, ascites, Mercedes or reversed T incisions, and previous IH. Prophylactic mesh might be safe and effective. CONCLUSIONS: IH after open HPB surgery is still an important matter. Some of the risk factors are specific for the HPB operations and the incision type should be carefully considered. Randomized controlled trials are required to confirm the role of prophylactic mesh after HPB operations.

Is prophylactic mesh closure effective to decrease the incidence of incisional hernia after laparotomy in colorectal surgery?

BACKGROUND: few studies have studied prophylactic mesh closure after laparotomy for colorectal surgery. METHODS: a retrospective cohort study was performed to compare patients with and without prophylactic mesh closure after open colorectal surgery. RESULTS: 309 patients were included from January 2014 to December 2016. Prophylactic mesh closure was performed in 98 patients (31.7%). After a mean follow-up of 21.7 months, incisional hernia was developed in 9 and 54 patients in the group with and without mesh respectively (9.2% vs. 25.7%, OR = 0.3, p = 0.001). In the multivariate Cox model prophylactic mesh closure was associated with a protective effect on incisional hernia development with a Hazard Ratio of 0.46 (p = 0.033). Surgical site infection was more frequent in the mesh group (19.4% vs. 9.5%, OR = 2.3, p = 0.015). CONCLUSIONS: prophylactic mesh closure is effective to decrease the incidence of incisional hernia after colorectal surgery.

Use of prophylactic mesh during initial stoma creation to prevent parastomal herniation: a systematic review and meta-analysis of randomised controlled trials.

AIM: Parastomal hernia (PSH) is a common complication following stoma creation. Previous reviews found mesh reinforcement during initial stoma creation beneficial in reducing PSH incidence. Since then, several multicentre randomised controlled trials (RCTs) produced widely ranging results rendering previous findings debatable. This current review assessed whether combining the latest larger multicentre RCTs would alter the previous findings. METHODS: The Cochrane Library, MEDLINE and Embase were searched from the respective dates of inception until 15 January 2021. RCTs were included if they compared mesh with no mesh during initial stoma creation in adult patients to prevent PSH. Included RCTs were summarised narratively and meta-analysed to estimate the relative risk (RR) of PSH incidence (primary analysis), peristomal complications and PSH repair (secondary analyses). Several subgroup analyses were performed, including mesh type (synthetic/biologic), surgical technique (open/laparoscopic) and mesh position (sublay/intraperitoneal). RESULTS: Thirteen RCTs were included in the primary meta-analysis (1070 patients); PSH incidence was reduced in patients with mesh compared with patients without mesh at maximal follow-up (RR = 0.54; 95% CI 0.39-0.77; I2  = 67%; P < 0.01). The number of PSH repairs was fewer in patients who had mesh (RR = 0.63; 0.35-1.14; I2  = 6%; P = 0.39), with no difference in peristomal complications (RR = 0.96; 0.55-1.70; I2  = 0%; P = 0.71), comparing with no mesh. Subgroup analyses suggested that placing synthetic mesh using an open sublay technique might be more beneficial. CONCLUSIONS: Prophylactic mesh reinforcement during initial stoma creation reduces PSH incidence and potentially its repair, without an increase in peristomal complications. However, substantial heterogeneity among included RCTs limits confidence in the results.

Long-term follow-up of prophylactic mesh reinforcement after emergency laparotomy. A retrospective controlled study.

BACKGROUND: Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies. METHODS: This study was a registered (NCT04578561) retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared. RESULTS: From an initial 266 emergency midline laparotomies, 187 patients were included. The median follow-up time was 64.4 months (SD 35). Both groups had similar characteristics, except for a higher rate of previous operations (62 vs. 43.2%; P = 0.01) and operation due to a revision laparotomy (32.5 vs.13%; P = 0.02) in the M group. During follow-up, 29.9% of patients developed an incisional hernia (Group S 36.6% vs. Group M 14.3%; P = 0.002). Chronic mesh infections were diagnosed in 2 patients, but no mesh explants were needed, and no patient in the M group developed chronic pain. Long-term risk factors for incisional hernia were as follows: smoking (HR = 2.47; 95% CI 1.318-4.624; P = 0.05), contaminated surgery (HR = 2.98; 95% CI 1.142-7.8; P = 0.02), surgical site infection (SSI; HR = 3.83; 95% CI 1.86-7.86; P = 0.001), and no use of prophylactic mesh (HR = 5.09; 95% CI 2.1-12.2; P = 0.001). CONCLUSION: Incidence of incisional hernias after emergency midline laparotomies is high and increases with time. High-risk patients, contaminated surgery, and surgical site infection (SSI) benefit from mesh reinforcement. Prophylactic mesh use is safe and feasible in emergencies with a low long-term complication rate. TRIAL REGISTRATION: NCT04578561. www.clinicaltrials.gov.

Closure of stoma site with or without prophylactic mesh reinforcement: a systematic review and meta-analysis.

AIMS: To evaluate comparative outcomes of the closure of temporary stoma site with or without prophylactic mesh reinforcement METHODS: A systematic online search was conducted using the following databases: PubMed, Scopus, Cochrane database, The Virtual Health Library, Clinical trials.gov and Science Direct. Studies comparing the reversal of stoma with and without prophylactic mesh reinforcement were included. Stoma site incisional hernia (SSIH), surgical site infection (SSI), operative time, seroma formation, haematoma formation, bowel obstruction, anastomosis leak, length of hospital stay (LOS) and secondary operation to repair the SSIH were the evaluated outcome parameters. RESULTS: Six comparative studies reporting a total of 1683 patients who underwent closure of stoma with (n = 669) or without (n = 1014) prophylactic mesh reinforcement were included. Use of mesh was associated with a significantly lower risk of SSIH (OR 0.22, P = 0.003) and need for surgical intervention to repair SSIH (OR 0.32, P = 0.04) compared with no use of mesh. However, it was associated with significantly longer operative time (MD 47.78, P = 0.02). There was no significant difference in SSI (OR 1.09, P = 0.59), bowel obstruction (OR 1.11, P = 0.74), seroma formation (OR 2.86, P = 0.19), anastomosis leak (OR 1.60, P = 0.15), haematoma formation (OR 1.25, P = 0.75) or LOS (MD - 0.45, P = 0.31) between two groups. CONCLUSION: Prophylactic mesh reinforcement during the closure of temporary stoma may significantly reduce the risk of SSIH and surgical intervention to repair the hernia without increasing the risk of SSI or other morbidities. However, it may increase the procedure time. Future higher-quality randomised evidence is required.

Impact of incisional hernia development following abdominal operations on total healthcare cost.

BACKGROUND: Introduction of the category III CPT code (0437T) for prophylactic mesh augmentation (PMA) highlights efforts to reduce incisional hernia (IH). PMA's value in the context of value-based care requires understanding both the cost of IH development and the savings from prevention. We hypothesized large healthcare costs with IH development. Appreciating which subsets of patients are at highest risk for IH, and the subsets who have the costliest care is essential in targeting interventions for hernia prevention. METHODS: Retrospective cohort study utilizing data from Truven Health Analytic MarketScan Commercial Claims and Encounters Database from calendar years 2011-2014. Adults undergoing open abdominal operations with continued enrollment 3-year post-surgery were included. Inpatient and outpatient claims were tracked over 3 years to identify IH. Quantile regression estimated the association between conditional distribution of total cost and IH. A generalized linear model with gamma distribution estimated the association of conditional mean of total cost and IH. Models were adjusted for confounding cost covariates (e.g., age, gender, obesity, smoking, cancer). RESULTS: 14,290 patients were identified, 1294 (9.1%) developed IH, 48% within 1-year, 33% at 1-2 years, and 19% at 2-3 years post-surgery. 515 underwent stoma creation, 4579 colon resection, 2263 liver/kidney, 3890 peritoneal, 3043 other (foregut, appendectomy, cholecystectomy). Rate of IH formation was 25, 13, 5.9, 6.3, and 6.3%, respectively. The difference in median expenditures for IH development versus no IH was ostomies: $26,098, colorectal: $21,211, liver/kidney: $23,811, peritoneal: $25,554, others: $28,870 (p < 0.0.01). IH within 1 year was more expensive than within 3 years in the following categories: colorectal ($16,034, p = 0.0385), liver/kidney ($27,145, p = 0.0004), and ostomy ($18,992, p = 0.0035). CONCLUSION: IH is a common occurrence imposing significant healthcare burden. Higher costs occur when IH occurs within 1 year versus 3 years from the index-procedure. This highlights the importance of hernia prevention techniques and the question of whether temporizing closure adjuncts  are appropriate in high-risk patients.

Prophylactic mesh to prevent parastomal hernia: a meta-analysis of randomized controlled studies.

The aim of the present meta-analysis was to determine whether prophylactic mesh decreases the odds of parastomal hernia formation. Randomized controlled trials referenced in MEDLINE or EMBASE between 1946 and 2016 comparing prophylactic mesh to standard stoma formation were included. The primary outcome was occurrence of parastomal hernia. Secondary outcomes were parastomal hernia requiring surgical intervention and complications. Odds ratios were calculated for the primary and secondary outcomes. Subgroup analyses were conducted based on mesh type, mesh location, laparoscopic versus open, and method of hernia diagnosis. Nine randomized controlled trials with 569 participants were included. There was a significant decrease in the odds of developing a parastomal hernia in the prophylactic mesh group [odds ratio (OR) 0.21, 95% confidence interval (CI) 0.11-0.38, p < 0.00001, I 2 = 36%], as well as decreased odds of requiring surgical repair (OR 0.36, 95% CI 0.15-0.87, p = 0.02, I 2 = 0%). There was no evidence that prophylactic mesh increased the odds of surgical complications (seven studies, OR 1.34, 95% CI 0.73-2.46, p = 0.34, I 2 = 34%) or stoma-specific complications (eight studies, OR 0.65, 95% CI 0.40-1.05, p = 0.08, I 2 = 0%). There was a subgroup effect with synthetic mesh associated with a lower incidence of parastomal hernias which was not appreciated in the biologic mesh group (test of subgroup effect p = 0.01). Five studies had a high risk of bias. The Grades of Recommendation, Assessment, Development and Evaluation quality of evidence was moderate. Prophylactic mesh is associated with decreased odds of parastomal hernia formation and the need for surgical repair. There is no evidence that mesh placement increases the odds of complications.

The use of an algorithm for prophylactic mesh use in high risk patients reduces the incidence of incisional hernia following laparotomy for colorectal cancer resection. / Un algoritmo para la colocación de malla profiláctica en pacientes de riesgo reduce la incidencia de hernia incisional tras laparotomía por cáncer colorrectal.

OBJECTIVE: Incisional hernia (IH) after colorectal surgery is highly prevalent. The objective of this study is to assess the utility of an algorithm to decide on mesh augmentation after a midline laparotomy for colorectal resection to prevent IH in high-risk patients. METHODS: A prospective study was conducted including all patients undergoing a midline laparotomy for colorectal resection between January 2011 and June 2014, after the implementation of a decision algorithm for prophylactic mesh augmentation in selected high-risk patients. Intention-to-treat analyses were conducted between patients in which the algorithm was correctly applied and those in which it was not. RESULTS: From the 235 patients analysed, the algorithm was followed in 166 patients, the resting 69 cases were used as a control group. From an initial adherence to the algorithm of 40% in the first semester, a 90.3% adherence was achieved in the seventh semester. The incidence of IH decreased as the adherence to the algorithm increased (from 28 to 0%) with a time-related correlation (R2=0.781). A statistically significant reduction in IH incidence was demonstrated in high-risk groups in which the algorithm was correctly applied (10,2 vs. 46,3%; p=0,0001; OR: 7,58;95%; CI: 3,8-15). Survival analysis showed that the differences remained constant during follow-up. CONCLUSION: The implementation of the algorithm reduces the incidence of IH in high-risk patients. The adherence to the algorithm also correlates with a decrease in the incidence of IH.

Long-term assessment of parastomal hernia prevention by intra-peritoneal mesh reinforcement according to the modified Sugarbaker technique.

BACKGROUND: Parastomal hernia (PSH) is a very frequent complication after creation of a permanent colostomy. The aim of that study is to assess the safety and the long-term efficacy of an intra-peritoneal onlay mesh (IPOM) positioned at the time of primary stoma formation to prevent PSH occurrence. MATERIALS AND METHODS: That multicentre prospective study concerned 29 consecutive patients operated for cancer of the low rectum between 2008 and 2014. There were 14 men and 15 women with a median age of 73 years (range 39-88) and a BMI of 28 (range 21-43). All the patients had potentially curative abdominoperineal excision associated with IPOM reinforcement of the abdominal wall with a round non-slit composite mesh centred on the stoma site and covering the lateralized colon according to the modified Sugarbaker technique. The major outcomes analysed were operative time, complications related to mesh and PSH incidence. Patients were evaluated at 6-month intervals for the first 2 years and thereafter annually with physical examination and CT scan control. For PSH evaluation, we used the classification of Moreno-Matias. RESULTS: Surgery was performed by laparoscopy in 24 patients and by laparotomy in 5; 17 had a trans-peritoneal colostomy and 12 an extra-peritoneal colostomy. The median size of the mesh was 15 cm (range 12-20), the operative time 225 min. (range 123-311) and the specific time for mesh placement 15 min. (range 10-30). With a median follow-up of 48 months (range 6-88), no mesh infection or complication requiring mesh removal were recorded. No patient developed a true PSH; two of them had a type Ia PSH (only containing the bowel forming the colostomy with a sac < 5 cm) and were totally asymptomatic. CONCLUSION: In our series, the incidence of PSH was 7 % and no specific mesh-related complication was noted. Prophylactic mesh reinforcement according to the modified Sugarbaker is an effective technique that addresses the issues related to the occurrence of PSH.

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial.

Background: Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. Methods: In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). Findings: Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. Interpretation: Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. Funding: B. Braun.

[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.

How often is prophylactic parastomal mesh placement performed after rectal resection without sphincter preservation? An analysis of German nationwide hospital discharge data among 41,697 patients.

PURPOSE: The European Hernia Society guidelines of parastomal hernias, published in 2017, strongly recommend prophylactic synthetic non-absorbable mesh upon the construction of a permanent end colostomy to reduce the incidence of parastomal hernias. This study aims to evaluate the implementation of the guidelines in Germany. METHODS: This is a retrospective multicentric analysis conducted in December 2022 at the University Hospital Brandenburg an der Havel. Anonymous data on rectal resection without sphincter preservation in the period 2010-2020 were extracted from the German nationwide hospital discharge data set. Individuals with a hernia and < 18 years old were excluded. Another exclusion criterion was a performed colectomy or proctocolectomy with an ileoanal pouch and placement of an absorbable mesh. The primary endpoint was the annual rate of prophylactic parastomal mesh placement following rectal resection without sphincter preservation in Germany. Cases reporting both non-absorbable mesh placement and rectal resection without sphincter preservation were considered prophylactic mesh insertions. RESULTS: A total of 41,697 patients received a rectal resection without sphincter preservation and without non-absorbable mesh placement. Among these individuals, 27,089 were male and 14,608 were female. The rate of reoperations (3.1%) and the length of hospital stay (25.3 days ± 19.32) remained almost constant during these 10 years. The rate of prophylactic mesh placement was increasing from 0.2% (n = 8) in 2010 to 6.4% (n = 198) in 2020. CONCLUSIONS: Currently, only the minority of patients who have undergone rectal resection without sphincter preservation receive prophylactic mesh insertion.

Prophylactic slowly resorbable mesh in midline laparotomy to limit incisional hernia incidence: the prospective 'Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS)' cohort study protocol.

Background: Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh ("investigational device"). However, the effectiveness of this mesh in IH prevention has not been proved. Methods: The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life. Discussion: Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.

Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial.

PURPOSE: Trocar site incisional hernia (TSIH) is a common complication of laparoscopic surgery. In the scientific literature there are few descriptions of methods or tools for its prevention. The aim of this report was to assess the effectiveness and safety of a prophylactic measure designed to lower rates of TSIH. METHODS: A multicenter randomized double-blinded clinical trial was performed in high-risk patients (diabetes mellitus and/or age ≥ 70 years and/or BMI ≥ 30 kg/m2 and/or extended incision for specimen retrieval) who underwent either elective or emergency laparoscopic cholecystectomy. Patients were assigned to prophylactic onlay polypropylene mesh fixation (intervention) or to standard trocar closure (control). The main aim was to analyze the efficacy of the intervention, taking occurrence of TSIH as the primary outcome. Clinical and radiological follow up lasted at least one year after surgery. Secondary endpoints were technique-related complications (surgical site occurrences). RESULTS: One hundred and forty-three patients were randomized and finally 116 were analyzed (64 in the intervention arm and 52 in the control arm). Groups were homogeneous. Mean [SD] age, 65 [18] years; 86 (60.6%) were women. The cumulative TSIH incidence was lower in the intervention group although the differences did not reach statistical significance, assessed either radiologically (16 [25.4%] vs 17 [31.5%], p = 0.538) or clinically (9 [16.1%] vs 9 [20], p = 0.613). No differences in surgical site infection, hematoma or seroma were detected. Mean follow-up was 670 days (range 223-1294). CONCLUSION: Our results show that, when properly assessed, the overall TSIH incidence is extremely high. Although polypropylene onlay mesh placement is safe, it does not appear to be effective in reducing the TSIH incidence rate. Radiological evaluation may be more accurate. TRIAL REGISTRATION: ClinicalTrials.org NCT03495557. Date of registration: April 12, 2018.

Prevention of incisional hernia after kidney transplantation: study protocol for a randomized controlled trial.

BACKGROUND: Incisional hernia is a common complication after kidney transplantation with an incidence of 1.6-18%. Concerning non-transplant patients, a recently published meta-analysis describes a reduction of the incidence of incisional hernia of up to 85% due to prophylactic mesh replacement in elective, midline laparotomy. The aim of our study is to show a reduction of the incidence of incisional hernia after kidney transplantation with minimal risk for complication. METHODS/DESIGN: This is a blinded, randomized controlled trial comparing time to incisional hernia over a period of 24 months between patients undergoing kidney transplantation and standardized abdominal closure with or without prophylactic placement of ProGrip™ (Medtronic, Fridley, MN, USA) mesh in an onlay position. As we believe that the mesh intervention is superior to the standard procedure in reducing the incidence of hernia, this is a superiority trial. DISCUSSION: The high risk for developing incisional hernia following kidney transplantation might be reduced by prophylactic mesh placement. ProGrip™ mesh features polylactic acid (PLA) microgrips that provide immediate, strong and uniform fixation. The use of this mesh combines the effectiveness demonstrated by the macropore propylene meshes in the treatment of incisional hernias, a high simplicity of use provided by its capacity for self-fixation that does not increase significantly surgery time, and safety. TRIAL REGISTRATION: ClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02-18-2021).

The effect of prophylactic mesh implantation on the development of incisional hernias in patients with elevated BMI: a systematic review and meta-analysis.

BACKGROUND: Incisional hernia is a common complication after midline laparotomy. In certain risk profiles incidences can reach up to 70%. Large RCTs showed a positive effect of prophylactic mesh reinforcement (PMR) in high-risk populations. OBJECTIVES: The aim was to evaluate the effect of prophylactic mesh reinforcement on incisional hernia reduction in obese patients after midline laparotomies. METHODS: Following the PRISMA guidelines, a systematic literature search in Medline, Web of Science and CENTRAL was conducted. RCTs investigating PMR in patients with a BMI ≥ 27 reporting incisional hernia as primary outcome were included. Study quality was assessed using the Cochrane risk-of-bias tool and certainty of evidence was rated according to the GRADE Working Group grading of evidence. A random-effects model was used for the meta-analysis. Secondary outcomes included postoperative complications. RESULTS: Out of 2298 articles found by a systematic literature search, five RCTs with 1136 patients were included. There was no significant difference in the incidence of incisional hernia when comparing PMR with primary suture (odds ratio (OR) 0.59, 95% CI 0.34-1.01, p = 0.06, GRADE: low). Meta-analyses of seroma formation (OR 1.62, 95% CI 0.72-3.65; p = 0.24, GRADE: low) and surgical site infections (OR 1.52, 95% CI 0.72-3.22, p = 0.28, GRADE: moderate) showed no significant differences as well as subgroup analyses for BMI ≥ 40 and length of stay. CONCLUSIONS: We did not observe a significant reduction of the incidence of incisional hernia with prophylactic mesh reinforcement used in patients with elevated BMI. These results stand in contrast to the current recommendation for hernia prevention in obese patients.