Phase
Condition
Obesity
Diabetes Prevention
Gastroesophageal Reflux Disease (Gerd)
Treatment
sleeve gastrectomy with omentopexy
sleeve gastrectomy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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-relatedcomorbidity (hypertension, obstructive sleep apnea syndrome, type II diabetes, earlyosteoarthritis 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 toparticipate in the research,
Patient with social security coverage.
Exclusion
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 orSingle Anastomosis Duodeno-Ileal bypass)
Patient participating in another interventional clinical research protocol involvinga drug or medical device
Patient who are pregnant, breastfeeding, or who have the potential to becomepregnant without effective contraception at the time of inclusion and up to 24months after surgery
Patient under guardianship, curators or legal protection,P
Study Design
Connect with a study center
CH de la Cote Basque
Bayonne,
FranceActive - Recruiting
CHD Vendée
La Roche sur Yon, 85000
FranceActive - Recruiting
Centre Hospitalier Emile Roux
Le Puy-en-Velay, 43012
FranceActive - Recruiting
CHU Nantes
Nantes, 44000
FranceActive - Recruiting
Clinique Jules Verne
Nantes, 44300
FranceActive - Recruiting
Centre Hospitalier Régional et Universitaire d'Orléans
Orléans,
FranceActive - Recruiting
Clinique Mutualiste de la Sagesse
Rennes,
FranceSite Not Available
Hopital Pontchaillou
Rennes, 35000
FranceActive - Recruiting
Clinique Santé Atlantique
Saint-Herblain, 44800
FranceActive - Recruiting
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