Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy
- Conditions
- Obesity
- Interventions
- Procedure: sleeve gastrectomy with omentopexyProcedure: sleeve gastrectomy
- Registration Number
- NCT04994665
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 526
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sleeve gastrectomy with omentopexy sleeve gastrectomy with omentopexy realization of a sleeve gastrectomy followed by an omentopexy Sleeve gastrectomy sleeve gastrectomy realization of a sleeve gastrectomy alone
- Primary Outcome Measures
Name Time Method Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone 2 years postoperatively Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
CHD Vendée
🇫🇷La Roche sur Yon, France
Centre Hospitalier Emile Roux
🇫🇷Le Puy-en-Velay, France
CH de la Cote Basque
🇫🇷Bayonne, France
Clinique Santé Atlantique
🇫🇷Saint-Herblain, France
CHU Nantes
🇫🇷Nantes, France
Clinique Jules Verne
🇫🇷Nantes, France
Centre Hospitalier Régional et Universitaire d'Orléans
🇫🇷Orléans, France
Clinique Mutualiste de la Sagesse
🇫🇷Rennes, France
Hopital Pontchaillou
🇫🇷Rennes, France