sleeve gastrectomysleeve gastrectomy with omentopexy
sleeve gastrectomy: The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
sleeve gastrectomy with omentopexy: 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
Study 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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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
Trial sites (9)
Facility
City
Region
Status
CH de la Cote Basque
Bayonne
France
Recruiting
CHD Vendée
La Roche-sur-Yon
France
Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay
France
Recruiting
CHU Nantes
Nantes
France
Recruiting
Clinique Jules Verne
Nantes
France
Recruiting
Centre Hospitalier Régional et Universitaire d'Orléans
Orléans
France
Recruiting
Hopital Pontchaillou
Rennes
France
Recruiting
Clinique Mutualiste de la Sagesse
Rennes
France
Not Yet Recruiting
Clinique Santé Atlantique
Saint-Herblain
France
Recruiting
More Centre Hospitalier Departemental Vendee trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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