Phase
Condition
Metabolic Syndrome
Obesity
High Cholesterol (Hyperlipidemia)
Treatment
sleeve gastrectomy with transit bipartition (SG +TB)
Roux-en-Y gastric bypass (RYGB)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient who has benefited from a pluridisciplinary evaluation, with a favorableopinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficientweight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20%)).
Patient who had benefited from an Upper GI Endoscopy with biopsies to look forHelicobacter Pylori (HP) and a HP eradication.
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 consentform
Patient affiliated to a healthcare insurance plan
Exclusion
Exclusion Criteria:
History of previous bariatric surgery, other than a Sleeve Gastrectomy
Patient with current BMI > 60 kg/m2
Presence of a severe and evolutive life threatening pathology, unrelated to obesity
History of Chronic inflammatory bowel disease
Type 1 Diabetes
Pregnancy or desire to be pregnant during the study
Nursing woman
Presence of Pylori Helicobacter resistant to medical treatment
Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 monthspreviously
Severe esophagitis (grade C of Los Angeles classification)
Hiatal hernia
Patients with unstable psychiatric disorder, 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
Patient incarcerated
Study Design
Study Description
Connect with a study center
Hop Claude Huriez Chu Lille
Lille, 59037
FranceSite Not Available
Hop Claude Huriez Chu Lille
Lille 2998324, 59037
FranceSite Not Available
CHU de Lyon
Lyon,
FranceSite Not Available
CHU de Lyon
Lyon 2996944,
FranceSite Not Available
CHU de Nantes
Nantes,
FranceSite Not Available
CHU de Nantes
Nantes 2990969,
FranceSite Not Available
CHU Orléans
Orléans,
FranceSite Not Available
CHU Orléans
Orléans 2989317,
FranceSite Not Available
AP-HP Hôpital Bichat
Paris,
FranceActive - Recruiting
AP-HP Hôpital Georges Pompidou
Paris,
FranceSite Not Available
AP-HP Hôpital Bichat
Paris 2988507,
FranceSite Not Available
AP-HP Hôpital Georges Pompidou
Paris 2988507,
FranceSite Not Available
CHU de Poitiers
Poitiers,
FranceSite Not Available
CHU de Poitiers
Poitiers 2986495,
FranceSite Not Available
CHU de Nancy
Vandœuvre-lès-Nancy,
FranceSite Not Available
CHU de Nancy
Vandœuvre-lès-Nancy 2970797,
FranceSite Not Available

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