Overview
The aim of the study is to assess impact of omentopexy on de novo gastro-oesophageal reflux disease (GERD) after sleeve gastrectomy.
This will be assess 2 years postoperatively. This study is a prospective, multicentric, randomized trial. Five hundred twenty six patients should be included with 263 in each arm. First arm will include patients who have a sleeve gastrectomy. The second arm will include patients who have sleeve gastrectomy with omentopexy.
Two years after surgery , it will be collected a CARLSSON score and BAROS score (quality of life).
The main objective is to show that omentopexy decreases the rate of de novo GERD after sleeve gastrectomy at 2 years postoperatively without the use of Proton-Pump Inhibitors (PPIs)
Eligibility
Inclusion Criteria:
- Patient ≥ 18 years old,
- Patient to be operated in first intention of a sleeve gastrectomy
- Initial BMI between 35Kg/m² and 40 Kg/m² associated with an obesity-related comorbidity (hypertension, obstructive sleep apnea syndrome, type II diabetes, early osteoarthritis authenticated by a rheumatologist or an orthopedist, dyslipidemia, hepatic steatosis) OR initial BMI ≥ 40 Kg/m².
- Multidisciplinary follow-up of at least 6 months before surgery
- Validation of the surgical intervention in a multidisciplinary consultation meeting
- Certificate of no contraindication by a psychiatrist
- Patient who has the capacity to understand the protocol and has given consent to participate in the research,
- Patient with social security coverage.
Exclusion Criteria:
- Eating disorder or mental disorder
- Misunderstanding of the protocol
- Psychiatric contraindication
- Initial BMI <35Kg/m².
- Initial BMI between 35Kg/m² and 40 Kg/m² without comorbidities.
- Esophagitis of grade B and above on the Oeso-Gastro-Duodenal Fibroscopy
- CARLSSON score (score ≥ 4) preoperatively
- Presence of a Proton-Pump Inhibitors treatment
- Patient to have a 2-stage surgery (first sleeve gastrectomy then gastric bypass or Single Anastomosis Duodeno-Ileal bypass)
- Patient participating in another interventional clinical research protocol involving a drug or medical device
- Patient who are pregnant, breastfeeding, or who have the potential to become pregnant without effective contraception at the time of inclusion and up to 24 months after surgery
- Patient under guardianship, curators or legal protection,P