Prevention Of Incisional Hernia Research Articles

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.

A SYSTEMATIC REVIEW AND META-REGRESSION OF FACTORS AFFECTING INCISIONAL HERNIA RATES IN MIDLINE INCISIONS OVER A 10-YEAR PERIOD

Abstract Aims The Incisional hernia (IH) rate after midline incisions was reported to be 12.8% in a systematic review of literature published in 2015. With updated guidance on abdominal wall closure techniques, the landscape of abdominal wall closure has changed. We aimed to update this literature to assess any change in the rates and any new identifiable risk factors for IH in midline incisions. Methods We undertook a systematic review of literature according to PRISMA guidelines and registered on PROSPERO. All papers reporting IH rates in midline incisions with primary suture closure between April 2013 — October 2022 were included. Papers with two or more arms suitable for inclusion were extracted independently. Results Sixty three papers (21 RCTs, 36 cohort studies and 6 case-control studies), comprising 18,126 patients were included. The mean IH rate was 16.8% at a weighted mean follow up of 31.3 months. Meta-regression identified two study level variables that correlated with an increase in IH rates (Use of radiology for diagnosis of IH and inclusion of patients undergoing a contaminated procedure) and one operative variable that corresponded with a decrease in rates (Small bites closure technique). Conclusions The Incisional hernia rate in midline incisions reported in the literature have increased over the last decade. A change in detection method and an increase in patient complexity may account for the majority of risk, suggesting standardisation of trial technique is essential in IH prevention trials. Small bites technique is associated with a significant reduction in IH rates, and future work should focus on strengthening the evidence base around this technique.

Protocol for an independent patient data meta-analysis of prophylactic mesh placement for incisional hernia prevention after abdominal aortic aneurysm surgery: a collaborative European Hernia Society project (I-PREVENT-AAA)

IntroductionIncisional hernia (IH) is a prevalent and potentially dangerous complication of abdominal surgery, especially in high-risk groups. Mesh reinforcement of the abdominal wall has been studied as a potential intervention...

Educating Residents in Abdominal Wall Closure: An Overview.

Background and Aims: Incisional hernia prevention has become an important concept for surgeons operating on the abdominal wall. Several techniques have been proposed to help decrease incisional hernia formation with suture closure of the abdominal wall being one of the cornerstones. Technical details that have been reported to decrease incisional hernia rates include achieving a 4:1 Suture to Wound length ratio and the use of a small bites technique. Despite evidence to support many of these techniques there appears to be a gap in practice patterns amongst practicing surgeons. Introducing and promoting these principles in surgical residency may help to close this gap. This paper reviews our experience with surgical training for abdominal wall closures at our institution. Materials and Methods: Programs and projects related to abdominal wall closure were reviewed from our institution from 2010-Present. Type of project, intervention, and impact on education was evaluated and summarized. Results: Seven projects were identified relating to surgical training and abdominal wall closure. Three projects dealt with skills training using an abdominal wall simulation model and related to suturing techniques. Two projects were clinical studies focused on suture to wound length ratios and improving outcomes with this variable in a residency training program. Two projects dealt with models relating to abdominal wall closure and education. Conclusion: Implementation of educational programs in surgical residency programs can lead to improvements in technique and knowledge around abdominal wall closure and help in research endeavors.

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

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. In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27kg/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). 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. 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. B. Braun.

Prevention of incisional hernia with retrorectus synthetic mesh versus biological mesh following loop ileostomy closure (Preloop trial).

The rate of incisional hernia after closure of a temporary loop ileostomy is significant. Synthetic meshes are still commonly avoided in contaminated wounds. The Preloop trial was a multicentre RCT designed to evaluate the benefits of synthetic mesh in incisional hernia prevention, and its safety for use in a contaminated surgical site compared with biological mesh. Study patients who underwent closure of a loop ileostomy after anterior resection for rectal cancer were assigned to receive either retrorectus synthetic or biological mesh to prevent incisional hernia. The primary outcomes were surgical-site infections within 30 days, and clinical or radiological incisional hernia incidence at 10 months. Secondary outcomes were reoperation rate, operating time, duration of hospital stay, other complications within 30 days of surgery, 5-year quality of life measured by RAND-36, and incisional hernia incidence within 5 years of follow-up. Between November 2018 and September 2021, 102 patients were randomised, of whom 97 received the intended allocation. At 10-month follow-up, 90 patients had undergone clinical evaluation and 88 radiological evaluation. One patient in each group (2 per cent) had a clinical diagnosis of incisional hernia (P = 0.950) and one further patient in each group had a CT-confirmed incisional hernia (P = 0.949). The number of other complications, reoperation rate, operating time, and duration of hospital stay did not differ between the study groups. Synthetic mesh appeared comparable to biological mesh in efficacy and safety for incisional hernia prevention at the time of loop ileostomy closure. NCT03445936 (http://www.clinicaltrials.gov).

Surgical site occurrence after prophylactic use of mesh for prevention of incisional hernia in midline laparotomy: systematic review and meta-analysis of randomized clinical trials.

The use of mesh is the standard for the prevention of incisional hernia (IH). However, the effect of surgical site occurrence (SSO) has never been compared. The aim of this meta-analysis was to evaluate the prevalence of SSO and measure its negative effect through the calculation of the number needed to treat for net effect (NNT net). A meta-analysis was performed according to the PRISMA guidelines. The primary objective was to determine the prevalence of SSO and IH, and the secondary objective was to determine the NNT net as a metric to measure the combined benefits and harms. Only published clinical trials were included. The risk of bias was analyzed, and the random effects model was used to determine statistical significance. A total of 15 studies comparing 2344 patients were included. The incidence of IH was significantly lower in the mesh group than in the control group, with an OR of 0.29 (95% CI 0.16-0.49, p = 0.0001). The incidence of SSO was higher in the mesh group than in the control group, with an OR of 1.21 (95% CI 0.85-1.72, p = 0.0001)but without statistical significance. Therefore, the way to compare the benefits and risks of each of the studies was done with the calculation of the NNT net, which is the average number of patients who need to be treated to see the benefit exceeding the harm by one event, and the result was 5, which is the average number of patients who need to be treated to see the benefit exceeding the harmby one event. The use of mesh reduces the prevalence of IH and it does not increases the prevalence of SSO, the NNT net determined that the use of mesh continues to be beneficial for the patient.

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

BackgroundIncisional 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/designThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT04794582. Registered on 08 March 2021. Protocol version 2.0. (02–18-2021).

P-065 SYNTHETIC MESH VERSUS BIOLOGICAL MESH TO PREVENT INCISIONAL HERNIA AFTER LOOP-ILEOSTOMY CLOSURE: A RANDOMIZED FEASIBILITY TRIAL

Abstract Aim Up to one third of patients experience incisional hernia after loop-ileostomy closure. Biological meshes have been commonly used in contaminated surgical sites instead of synthetic ones due to complication concerns, previous data on the subject does not support this practice. The aim of this study was to evaluate the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. Materials &amp; Methods A randomized, controlled, multi-center non-inferior feasibility trial was conducted from April 2018 – November 2021. Patients (n=102) were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene MacroTM, Medtronic) (SM) or a biological mesh (PermacolTM, Medtronic) (BM) to the retrorectus space at loop-ileostomy closure after anterior resection for rectal adenocarcinoma. The primary outcome was rate of surgical site infections (SSI) at 30-day follow-up and rate of incisional hernias at 10 months follow-up. Results In total, 102 patients were randomized, of which 97 received the intended allocation. Of patients in the SM group, 1/46 (2%) had SSI and in the BM group 2/48 (4%) had SSI (p&amp;gt;0.90) at 30 days follow-up. One patient from each group underwent reoperation requiring mesh removal (p&amp;gt;0.90). At 10 months follow-up, one patient (2%) in both groups had an incisional hernia on clinical examination (p&amp;gt;0.90) at 10 months follow-up. None of the patients had underwent reoperation due to mesh or wound-related complications. Conclusions Both a synthetic mesh and biological mesh were safe and effective in incisional hernia prevention after loop-ileostomy closure.

P-015 PREVENTION OF INCISIONAL HERNIA WITH ONLAY MESH IN LOOP ILEOSTOMY CLOSURE

Abstract Aim The primary aim of the study is to determine the efficacy of the placement of an onlay mesh for prevention of incisional hernia after loop ileostomy closure Material &amp; Methods This is a multicentric, prospective, randomized controlled trial including patients operated on for loop ileostomy closure after a prior rectal resection for rectal cancer. In the control group (C), after the digestive tract is reconstructed, the closure of the abdominal wall is performed by a 4:1 ratio running suture of polydioxanone. Patients in the study group (M) had the same closure procedure performed, and a light polypropilene mesh is placed onlay. The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits and radiologically by an abdominal CT scan performed at the end of follow-up (6 month after surgery) Results 58 patients were included (27 in control group and 31 in mesh group) . Both groups had similar characteristics, except for a higher rate of smokers in the control group (48% vs 6%). During the follow-up, 5% of patients developed an incisional hernia (Group M 0 vs Group C 11%). At 30 days of follow-up 5 (16%) surgical site occurrences were detected in Group M for 4 (15%) in Group C. Conclusions A low incidence of IH after ileostomy closure is detected. All the IH were presented in the control group with no stadistically significant differences between groups. Larger trials with longer follow-up are needed to confirm the results.

Surgeon perspectives on the STITCH trial: a mixed methods study.

Incisional hernia prevention strategies related to fascial closure technique during laparotomy are well described yet poorly implemented in practice. The factors hindering the surgeon's adoption of evidence-based techniques for fascial closure are poorly understood and characterized. Using an exploratory sequential mixed methods design, we first collected 139 responses to a validated quantitative survey based on a Theoretical Domain Framework for adoption of healthcare practices. Mean scores from survey responses were tabulated, and the findings were used to develop an interview guide for subsequent qualitative individual semi-structured phone interviews. Fourteen practicing surgeons were purposively sampled from social media outlets andour institution. The interviews were recorded and transcribed verbatim for coding and thematic analysis usingNVivo12 Plus. Data from the surveys and interviews were integrated using joint displays. Quantitative and qualitative analyses from surveys and semi-structured interviews revealed various themes related to surgeon decision-making related to fascial closure technique. Surgeons cited limitations of prior studies, applicability of findings, anecdotal experiences, and situation-specific environments that influence their decision-making. Peer influence and lack of training also affected surgeons' perspectives on integrating small bite technique into practice. Trial design limitations, peer influence, and patient-specific factors impacted surgeon decision-making in the choice of fascial closure technique. Future clinical trials in diverse patient populations may improve surgeons' confidence in implementing technique for fascial closure.

Synthetic mesh versus biological mesh to prevent incisional hernia after loop-ileostomy closure: a randomized feasibility trial

BackgroundIncisional hernia is a frequent complication after loop-ileostomy closure, rationalizing hernia prevention. Biological meshes have been widely used in contaminated surgical sites instead of synthetic meshes in fear of mesh related complications. However, previous studies on meshes does not support this practice. The aim of Preloop trial was to study the safety and efficacy of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure.MethodsThe Preloop randomized, feasibility trial was conducted from April 2018 until November 2021 in four hospitals in Finland. The trial enrolled 102 patients with temporary loop-ileostomy after anterior resection for rectal cancer. The study patients were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene Macro™, Medtronic) (SM) or a biological mesh (Permacol™, Medtronic) (BM) to the retrorectus space at ileostomy closure. The primary end points were rate of surgical site infections (SSI) at 30-day follow-up and incisional hernia rate during 10 months’ follow-up period.ResultsOf 102 patients randomized, 97 received the intended allocation. At 30-day follow-up, 94 (97%) patients were evaluated. In the SM group, 1/46 (2%) had SSI. Uneventful recovery was reported in 38/46 (86%) in SM group. In the BM group, 2/48 (4%) had SSI (p > 0.90) and in 43/48 (90%) uneventful recovery was reported. The mesh was removed from one patient in both groups (p > 0.90).ConclusionsBoth a synthetic mesh and biological mesh were safe in terms of SSI after loop-ileostomy closure. Hernia prevention efficacy will be published after the study patients have completed the 10 months’ follow-up.

Effect of Suture Length on the Incidence of Incisional Hernia and Surgical Site Infection in Patients Undergoing Midline Laparotomy: A Systematic Review and Meta-Analysis.

The development of an incisional hernia is a common complication of midline laparotomy. Improper fascial closure techniques have a significant role in its development. It can also lead to poor wound healing and increase the risk of developing surgical site infections (SSI). Upon conducting a thorough literature review, various studies have been conducted on closing abdominal wounds. However, there is a dearth of studies portraying the role of suture length in the prevention of incisional hernia and SSI. The effect of using a greater suture-to-wound length ratio on postoperative outcomes was not clearly analyzed or described. The objective of this study is to assess the effectiveness of using a suture length to wound length ratio ≥4:1 versus a ratio <4:1 in preventing postoperative complications such as incisional hernia and SSI. This study is a systematic review of randomized controlled trialson abdominal wound closure using a suture length to wound length ratio of≥4:1 and <4:1. published in PubMed, Google Scholar, and Cochrane library. The inclusion and exclusion criteria were defined. The relevant studies identified from 1991 to 2017, were included in the analysis. The primary endpoint was the incidence of incisional hernia, and the secondary outcome was the incidence of SSI. This meta-analysis considered five randomized controlled trials that compared the effects of using different suture lengthto wound length ratios during abdominal closure on incisional hernia and SSI. Participants ranged in size from 100 to 363. The trial follow-up period ranged from a minimum of 10 months to five years. The outcomes studied in the two groups were incisional hernia and SSI. The relative risk of the occurrence of incisional hernia if the suture length to wound length ratio was ≥4:1 was 0.42 with a p-value of <0.001 which was considered significant. This implied that usinga suture length of more than four times that of the wound i.e., 4:1, significantly decreases the risk of developing an incisional hernia by more than half. The relative risk of developing a SSI was 0.98 with a p-value of 0.966. Thus, this method of abdominal closure uing a longer suture length to wound length ratio does not contribute to an increased incidence or significant change in the risk of developing SSI.

Defining High-Risk Patients Suitable for Incisional Hernia Prevention.

OPINION J. Abdom. Wall Surg., 03 February 2023 https://doi.org/10.3389/jaws.2023.10899

If Evidence is in Favor of Incisional Hernia Prevention With Mesh, why is it not Implemented?

OPINION J. Abdom. Wall Surg., 01 February 2023 https://doi.org/10.3389/jaws.2023.11000

Incisional hernia prevention: risk–benefit from a patient perspective (INVITE) – protocol for a single-centre, mixed-methods, cross-sectional study aiming to determine if using prophylactic mesh in incisional hernia prevention is acceptable to patients

IntroductionIncisional hernia (IH) is a common complication of abdominal surgery affecting between 10% and 20% of patients and is associated with significant morbidity along with cost to the National Health...

Innovations for Incisional Hernia Prevention.

Incisional hernias are the most frequent long-term complication of abdominal surgery, resulting in considerable patient morbidity and increased health care costs. These hernias frequently result from excessive tension concentrated at points along the suture line of the abdominal closure. While ample research is focused on developing improved repair materials, the optimal solution to the problem of incisional hernias is prevention. Accordingly, some investigators have postulated that incisional hernias can be prevented by distributing tension more evenly along the fascial closure. Herein we describe two novel and ingenious strategies for the improved distribution of tension when closing abdomens (T-Line® Hernia Mesh and the REBUILD Bioabsorbable™) that were conceived of and developed by surgeons.

Measurement of Closure Forces During Abdominal Wall Closure as a New Parameter for Incisional Hernia Prevention: an Experimental Animal Study

Measurement of Closure Forces During Abdominal Wall Closure as a New Parameter for Incisional Hernia Prevention: an Experimental Animal Study

P-070 SYNTHETIC MESH VERSUS BIOLOGICAL IMPLANT TO PREVENT INCISIONAL HERNIA AFTER LOOP-ILEOSTOMY CLOSURE: A RANDOMIZED FEASIBILITY TRIAL

Abstract Aim The aim of this study was to evaluate the safety and efficiency of synthetic mesh compared to a biological mesh in incisional hernia prevention after loop-ileostomy closure. Material &amp; Methods Up to one third of patients experience incisional hernia after loop-ileostomy closure, justifying hernia prevention procedures. Although biological meshes have been widely used in contaminated surgical sites instead of synthetic ones due to complication concerns, previous data on the subject does not support this practice. A randomized, controlled, multi-center non-inferior feasibility trial was conducted from April 2018 – November 2021. Patients (n=102) were randomized 1:1 to receive either a light-weight synthetic polypropylene mesh (Parietene MacroTM, Medtronic) (SM) or a biological mesh (PermacolTM, Medtronic) (BM) to the retrorectus space at loop-ileostomy closure after anterior resection for rectal adenocarcinoma. The primary outcome was rate of surgical site infections (SSI) at 30-day follow-up. Results In total, 102 patients were randomized, of which 97 received the intended allocation. At 30-day follow-up, 94 patients (97%) were evaluated. Of patients in the SM group, 1/46 (2%) had SSI and in the BM group 2/48 (4%) had SSI (p&amp;gt;0.90). Uneventful wound healing was recorded in 38/46 (86%) and 43/48 (90%) patients in the SM and BM groups, respectively. One patient from each group underwent reoperation requiring mesh removal (p&amp;gt;0.90). Conclusions Both a synthetic mesh and biological mesh were safe in incisional hernia prevention after loop-ileostomy closure. Hernia prevention efficiency will be reported after long-term patient follow-ups.

National epidemiologic trends (2008-2018) in the United States for the incidence and expenditures associated with incisional hernia in relation to abdominal surgery.

It is unknown whether the trend of rising incisional hernia (IH) repair (IHR) incidence and costs until 2011 currently persists. We aimed to evaluate how the IHR procedure incidence, cost and patient risk-profile have changed over the last decade relative to all abdominal surgeries (AS). Repeated cross-sectional analysis of 38,512,737 patients undergoing inpatient 4AS including IHR within the 2008-2018 National Inpatient Sample. Yearly incidence (procedures/1,000,000 people [PMP]), hospital costs, surgical and patient characteristics were compared between IHR and AS using generalized linear and multinomial regression. Between 2008-2018, 3.1% of AS were IHR (1,200,568/38,512,737). There was a steeper decrease in the incidence of AS (356.5 PMP/year) compared to IHR procedures (12.0 PMP/year) which resulted in the IHR burden relative to AS (2008-2018: 12,576.3 to 9,113.4 PMP; trend difference P &lt; 0.01). National costs averaged $47.9 and 1.7 billion/year for AS and IHR, respectively. From 2008-2018, procedure costs increased significantly for AS (68.2%) and IHR (74.6%; trends P &lt; 0.01). Open IHR downtrended (42.2%), whereas laparoscopic (511.1%) and robotic (19,301%) uptrended significantly (trends P &lt; 0.01). For both AS and IHR, the proportion of older (65-85y), Black and Hispanic, publicly-insured, and low-income patients, with higher comorbidity burden, undergoing elective procedures at small- and medium-sized hospitals uptrended significantly (all P &lt; 0.01). IH persists as a healthcare burden as demonstrated by the increased proportion of IHR relative to all AS, disproportionate presence of high-risk patients that undergo these procedures, and increased costs. Targeted efforts for IH prevention have the potential of decreasing $17M/year in costs for every 1% reduction.