RecruitingPhase 3NCT05488288

Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial

Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

354 participants

Start Date

Jul 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to demonstrate that hernia recurrence (VH) repair with non absorbable mesh concomitant to Bariatric Surgery (BS) decreases the risk of VH, with or without surgical repair, during the first two years after BS when compared to VH suture repair without mesh. As secondary objectives, the study aims to assess the impact of concomitant VH repair with non absorbable mesh versus suture repair in morbidly obese BS candidates on the following measures: - hernia recurrence at 1 year after randomization; - reoperation for hernia recurrence at 2 years after randomization; - strangulated hernia, surgical infection and mesh bulging at one year after randomization; - postoperative morbidity and mortality at 90 days after randomization; - benefit-risk ratio; - chronic pain at three months, six months, one year and two years after randomization; - quality of life during the two years after randomization; - incremental cost utility ratio; - short- and mid-term weight loss. To study if the efficacy of mesh versus suture VH repair differs according to the type and size of VH and to the surgical technique.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Mesh repair and a procedure called Suture repair for people with ventral hernia. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREMesh repair

Abdominal ventral hernia (VH) repair with mesh during bariatric surgery. the repair technique and the type of mesh are left to the choice of the center, as there are no strong data to demonstrate which technique is the best for VH repair in this population.

PROCEDURESuture repair

The hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.


Locations(1)

Department of visceral and digestive surgery, Louis Mourier hospital, APHP

Colombes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05488288


Related Trials