Randomized Trial of Ventral Hernia Repair With Mesh Versus Suture During Bariatric Surgery in Adults Aged 18 to 60

What this Trial Is About

This research aims to assess the effectiveness of using non absorbable mesh versus suture repair for ventral hernia VH during bariatric surgery BS in adults aged 18 to 60 years with morbid obesity. The main goal is to see if mesh repair lowers the chance of hernia returning within two years after surgery compared to suture repair. The study also evaluates other outcomes such as hernia recurrence at one year, need for reoperation, surgical complications, chronic pain, quality of life, weight loss, and cost-effectiveness. Participants will be randomly assigned to one of two groups one receiving VH repair with non absorbable mesh placed during BS either sleeve gastrectomy or bypass, and the other having suture repair of the hernia during BS. The mesh repair technique and mesh type depend on each surgical centers choice. The suture repair involves removing the hernia sac and closing the defect with slowly absorbable sutures through an open approach. Both groups undergo the bariatric procedure as decided before surgery. Throughout the study, patients will be monitored according to clinical guidelines with follow-up visits at 1, 3, 6, 9, 12, 18, and 24 months after surgery. Researchers will assess hernia recurrence rates, complications like infection or hernia strangulation, chronic pain levels, quality of life, weight loss progress, and costs. Safety and postoperative morbidity and mortality will be tracked up to 90 days after surgery. The study includes 29 surgical centers aiming to enroll 354 patients, with statistical analyses planned after follow-up completion and an interim analysis halfway through.

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