Dataset Information

Midline incisional hernia prophylaxis using synthetic mesh in an emergency or urgent gastrointestinal tract surgery: a protocol for multicentre randomised clinical trial.

ABSTRACT:

Introduction

Between 5% and 30% of abdominal incisions eventually result in incisional hernias (IHs) that can lead to severe complications and impaired quality of life. Unfortunately, IH repair is often unsuccessful; therefore, hernia prophylaxis is an important issue. The efficacy of mesh augmentation has been proven for hernia prophylaxis in high-risk patients, but no randomised clinical trial has evaluated prophylactic mesh placement in emergency/urgent gastrointestinal operations.

Methods and analysis

A multicentre, prospective randomised, open and patient-assessor blinded endpoint design will be conducted. A total of 470 patients will be enrolled and randomly allocated to retrorectus mesh augmentation with lightweight polypropylene mesh or primary suture closure. The primary outcome is IH occurrence within 24 months of follow-up, while other clinical outcomes are secondary endpoints. A cost-effectiveness analysis will be conducted from the societal and provider perspectives.

Ethics and dissemination

Ethics approval was obtained from Ramathibodi Hospital (MURA2020/1478) and Vajira Hospital (COA164/2563). The protocol is on the process of submission to the local ethics committee of the other study sites. Results will be submitted for publication in a peer-reviewed journal.

Trial registration number

TCTR20200924002.

SUBMITTER: Tansawet A

PROVIDER: S-EPMC8420735 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionIncisional hernia (IH) is the most frequent mid-term and long-term complication after midline laparotomy. The current standard treatment includes repair using a mesh. In a contaminated field, the use of a non-absorbable mesh increases the risk of surgical site infection and the costs. Slowly absorbable meshes are safe in contaminated fields, but no data have been reported regarding their long-term recurrence rate. COMpACT-BIO is a multicentre prospective randomised controlled phase III trial designed to compare the 3-year recurrence rate in patients undergoing contaminated IH repair with either a slowly absorbable mesh or standard care.MethodsIn patients undergoing midline IH repair in a contaminated surgical field (grade III of the modified Ventral Hernia Working Group classification), the COMpACT-BIO study compares the use of a slowly absorbable mesh with that of conventional care according to standardised surgical procedures (primary closure, non-absorbable synthetic mesh or biologic mesh, at the discretion of the surgeon). Randomisation is done during surgery before closure the fascia with an allocation ratio of 1:1. The choice of the slowly absorbable mesh is left to the criteria of each centre. The primary endpoint is the proportion of patients with scan-confirmed IH recurrence within 3 years after repair.Ethics/disseminationThis trial is conducted in compliance with international standards for research practice and reporting. Written informed consent will be obtained from patients prior to inclusion. All data were identified and anonymised prior to analysis. The protocol has been approved by an Institutional Review Board (2020-A0823-36/SI:20.07.03.66831), and will be conducted in compliance with the CONSORT (Consolidated Standards of Reporting Trials) statement. Results will be submitted for publication in peer-reviewed medical journals and presented to patients and healthcare professionals.Protocol versionVersion 2-13 October 2020.Trial registration numberNCT04597840.