Bariatric SUrgery With Mesh REpair of Ventral Hernia: a Randomized Controlled Trial (BeSURE)
Ventral Hernia
About this trial
This is an interventional treatment trial for Ventral Hernia focused on measuring Ventral Hernia, Bariatric surgery, Obesity, Mesh repair, Suture
Eligibility Criteria
Inclusion Criteria:
- Patients between 18 and 60 years.
- Body Mass Index (BMI) ≥ 40 kg/m² or ≥ 35 kg/m² associated with at least one comorbidity that can improve after BS.
- Body Mass Index (BMI) < 50 kg/m².
- Primary or first recurrent incisional midline VH, umbilical or epigastric, width between 1 cm and 4 cm, on abdominopelvic CT-scan without contrast injection.
- Decision for primary sleeve gastrectomy or by-pass after multidisciplinary discussion.
- Request for BS approved by health insurance authorities.
- Written informed consent from patient.
Exclusion Criteria:
- Previous VH repair with mesh.
- Other types of abdominal hernia (lateral, subxiphoidal, infraumbilical, suprapubic, parastomal, non-midline port-site, and groin hernia).
- Decision of performing BS by laparotomy.
- Reoperation for BS (excepted previous adjustable gastric banding).
- Ongoing abdominal skin infection.
- Emergency surgery.
- ASA (American Society of Anesthesiologists) score>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.
Sites / Locations
- Department of visceral and digestive surgery, Louis Mourier hospital, APHPRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Mesh group
Suture group
ventral hernia repair with non absorbable mesh placement concomitant to bariatric procedure (sleeve gastrectomy or by-pass). In this group, 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.
suture repair of ventral hernia concomitant to bariatric procedure (sleeve gastrectomy or by-pass). In this group, the hernia sack is resected through an open approach, and the fascial defect is systematically closed with a slowly absorbable monofilament suture.