Sleeve gastrectomy
ProcedureThe sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
NCT Number: NCT04994665
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
CH de la Cote Basque, Bayonne, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
OR initial BMI ≥ 40 Kg/m².
Exclusion criteria
The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
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
Time frame: 2 years postoperatively
Presence of de novo GERD defined by a clinical score of CARLSSON >= 4 and/or the use of a PPIs treatment
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Departemental Vendee
Other
Acronym: Sleevepexie
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