Last updated: December 26, 2023
Sponsor: University Hospital, Lille
Overall Status: Active - Recruiting
Phase
N/A
Condition
Obesity
Diabetes Prevention
Treatment
Roux-en-Y gastric bypass (RYGB)
sleeve gastrectomy with transit bipartition (SG +TB)
Clinical Study ID
NCT04915014
2020_10
2020-A02656-33
PHRC-19-031
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 (accordingto HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery)after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 monthsafter 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 consent form
- 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
Total Participants: 320
Treatment Group(s): 2
Primary Treatment: Roux-en-Y gastric bypass (RYGB)
Phase:
Study Start date:
July 23, 2021
Estimated Completion Date:
July 31, 2025
Study Description
Connect with a study center
Hop Claude Huriez Chu Lille
Lille, 59037
FranceActive - Recruiting
CHU de Lyon
Lyon,
FranceActive - Recruiting
CHU de Nantes
Nantes,
FranceActive - Recruiting
CHU Orléans
Orléans,
FranceActive - Recruiting
AP-HP Hôpital Bichat
Paris,
FranceActive - Recruiting
AP-HP Hôpital Georges Pompidou
Paris,
FranceActive - Recruiting
CHU de Poitiers
Poitiers,
FranceActive - Recruiting
CHU de Nancy
Vandœuvre-lès-Nancy,
FranceActive - Recruiting
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