Phase
Condition
Obesity
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients included in the YOMEGA study, randomized and operated on with the techniqueassigned to them (121 RYGB and 127 MGB). The main inclusion criteria for the YOMEGA study were:
- Aged between 18 and 65 years old
- Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or moreco-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia,arthritis)
- Patient who has benefited from an upper GI endoscopy with biopsies
- Patient who has benefited from a pluridisciplinary evaluation, with a favorableopinion for a gastric bypass
- Patient who understands and accepts the need for a long term follow-up
- Patient who agrees to be included in the study and who signs the informed consent form
- Patient affiliated to a healthcare insurance plan
Exclusion
Exclusion Criteria: Patients randomized in the YOMEGA study, not operated on with the technique assigned tothem. Main non-inclusion criteria for the YOMEGA study:
- History of esophagitis on upper GI endoscopy (Los Angeles classification)
- Severe gastroesophageal reflux disease (GERD), resistant to medical treatment
- Presence of dysplastic modifications of the gastric mucosa or a history of gastriccancer, on upper gastrointestinal endoscopy.
- Presence of Helicobacter Pylori resistant to medical treatment
- Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 monthspreviously
- History of previous bariatric surgery (gastric band, sleeve gastrectomy, verticalbanded gastroplasty)
- Presence of a severe and evolutive life threatening pathology, unrelated to obesity
- Presence of chronic diarrhea (≥3 loose or liquid stools per day, over a period of morethan 4 weeks)
- Pregnancy or desire to be pregnant during the study
- Binge eating disorders or other eating disorders according to DSM V criteria (Diagnostic and Statistical Manual of Mental Disorders)
- Mentally unbalanced patients, under supervision or guardianship
- Patient who does not understand French/is unable to give consent
- Patient not affiliated to a French or European healthcare insurance
- Patient who has already been included in a trial which has a conflict of interestswith the present study
Study Design
Study Description
Connect with a study center
Cabinet de chirurgie générale, digestive et de l'obésité - Hôpital Privé Drôme et Ardèche
Guilherand-Granges, 07500
FranceActive - Recruiting
Service de Chirurgie Générale et Endocrinienne - Hôpital Claude Huriez - CHU de Lille
Lille, 59037
FranceActive - Recruiting
Service de Chirurgie Digestive Hôpital Edouard Herriot
Lyon,
FranceActive - Recruiting
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
Paris, 75013
FranceActive - Recruiting
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
Paris, 75908
FranceActive - Recruiting
AP-HP Hôpîtal Europeen Georges Pompidou
Paris Cedex 15, 75908
FranceActive - Recruiting
Service de Chirurgie Générale - Hôpital Privé de la Loire
Saint Etienne, 42100
FranceActive - Recruiting
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
Saint-Grégoire, 35760
FranceActive - Recruiting
Service de Chirurgie Générale, Digestive et Viscérale - Centre Hospitalier Intercommunal de Poissy / Saint Gerrmain en Laye
Saint-germain-en-laye, 78100
FranceActive - Recruiting

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