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

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.

NCT Number	NCT05488288
Lead Sponsor	Assistance Publique - Hôpitaux de Paris
Conditions	Ventral Hernia
Enrollment	354 participants
Start Date	2023-07-24
Primary Completion	2030-01 (estimated)
Study Completion	2030-01 (estimated)
Updated on ClinicalTrials.gov	2023-08-31