Clinical trial

Evaluation of Omentopexy on Gastro-oesophageal Reflux Following Sleeve Gastrectomy

Recruiting now · Not applicable · 1 countries · Registry ID NCT04994665

Recruiting nowNot applicableInterventional

What this study is 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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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 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

Treatments and study arms

sleeve gastrectomy

Procedure

The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed

sleeve gastrectomy with omentopexy

Procedure

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

Primary outcomes

Evaluate de novo GERD of patient benefited from sleeve gastrectomy with omentopexy versus sleeve gastrectomy alone2 years postoperatively

Presence of de novo GERD defined by a clinical score of CARLSSON \>= 4 and/or the use of a PPIs treatment

Study locations

9 locations were listed when this page was built. The first 40 are shown.

CH de la Cote Basque🇫🇷 Bayonne, France
Renaud GONTIER, DrPrincipal Investigator
CHD Vendée🇫🇷 La Roche-sur-Yon, France
Emeric ABET, DrPrincipal Investigator
Centre Hospitalier Emile Roux🇫🇷 Le Puy-en-Velay, France
Luis Matias BRUNAPrincipal Investigator
CHU Nantes🇫🇷 Nantes, France
Claire BLANCHARD, DrPrincipal Investigator
Clinique Jules Verne🇫🇷 Nantes, France
Laurent POTIRONPrincipal Investigator
Centre Hospitalier Régional et Universitaire d'Orléans🇫🇷 Orléans, France
Adel ABOU-MRAD, DrPrincipal Investigator
Clinique Mutualiste de la Sagesse🇫🇷 Rennes, France
Damien BERGEAT, DrPrincipal Investigator
Hopital Pontchaillou🇫🇷 Rennes, France
Marie LIVIN, DrPrincipal Investigator
Clinique Santé Atlantique🇫🇷 Saint-Herblain, France
Antoine SINA, DrPrincipal Investigator