Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Study Overview
=================
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)

Official Title
-----------------
Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy
* Procedure: sleeve gastrectomy with omentopexy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve gastrectomy<br>realization of a sleeve gastrectomy alone | Procedure: sleeve gastrectomy<br>* The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed<br>|
| Experimental: sleeve gastrectomy with omentopexy<br>realization of a sleeve gastrectomy followed by an omentopexy | Procedure: sleeve gastrectomy with omentopexy<br>* After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone | Presence of de novo GERD defined by a clinical score of CARLSSON >= 4 and/or the use of a PPIs treatment | 2 years postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleeve gastrectomy, omentopexy, gastro-oesophageal disease