Actively Recruiting
Bariatric Surgery With Mesh Repair of Ventral Hernia: a Randomized Controlled Trial
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-08-31
354
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 center's 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.
CONDITIONS
Brief Title
Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients between 18 and 60 years old
- Body Mass Index (BMI) of 40 kg/m² or higher, or 35 kg/m² or higher with at least one obesity-related comorbidity that can improve after bariatric surgery
- Body Mass Index (BMI) less than 50 kg/m²
- Primary or first recurrent incisional midline ventral hernia, umbilical or epigastric, with a width between 1 cm and 4 cm confirmed by abdominopelvic CT scan without contrast
- Planned primary sleeve gastrectomy or bypass decided after multidisciplinary discussion
- Approval for bariatric surgery by health insurance authorities
- Written informed consent from the patient
You will not qualify if you...
- Previous ventral hernia repair with mesh
- Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernias)
- Planned bariatric surgery by laparotomy
- Reoperation for bariatric surgery (except previous adjustable gastric banding)
- Ongoing abdominal skin infection
- Emergency surgery
- American Society of Anesthesiologists (ASA) score greater than 3
- Ongoing pregnancy or breast-feeding
- Patient not covered by social insurance
- Patient under legal guardianship
- Patient already included in a clinical trial on hernia recurrence
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day (day of surgery)
Participants undergo bariatric surgery combined with either mesh or suture repair of ventral hernia.
1 visit (hospital admission for surgery)
Duration - Up to 2 years after surgery
Participants are followed according to clinical guidelines after surgery to monitor recovery and outcomes.
Visits at 1, 3, 6, 9, 12, 18, and 24 months after surgery
Trial Site Locations
Total: 1 location
1
Department of visceral and digestive surgery, Louis Mourier hospital, APHP
Colombes, France, 92025
Actively Recruiting
Research Team
D
David MOSZKOWICZ, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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