Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy (Sleevepexie)

Centre Hospitalier Departemental Vendee

Status: Enrolling

Conditions: Obesity

Treatments: Procedure: sleeve gastrectomy with omentopexy; Procedure: sleeve gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04994665

CHD21_0032

Details and patient eligibility

About

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)

Enrollment: 526 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 at least one severe comorbidity likely to be improved after surgery according to HAS recommendations.

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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526 participants in 2 patient groups

Sleeve gastrectomy

Active Comparator group

Description:

realization of a sleeve gastrectomy alone

Treatment:

Procedure: sleeve gastrectomy

sleeve gastrectomy with omentopexy

Experimental group

Description:

realization of a sleeve gastrectomy followed by an omentopexy

Treatment:

Procedure: sleeve gastrectomy with omentopexy