Status:
UNKNOWN
Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Severe Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions...
Detailed Description
In these 2 populations of patients, more malabsorptive procedures like long limb One Anastomosis Gastric Bypass or Bilio-Pancreatic Diversion with Duodenal Switch could be more efficient but induce te...
Eligibility Criteria
Inclusion
- Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion 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 insufficient weight 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 for Helicobacter 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
- 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 months previously
- 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 interests with the present study
- Patient incarcerated
Key Trial Info
Start Date :
July 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04915014
Start Date
July 23 2021
End Date
July 1 2025
Last Update
December 27 2023
Active Locations (8)
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1
Hop Claude Huriez Chu Lille
Lille, France, 59037
2
CHU de Lyon
Lyon, France
3
CHU de Nantes
Nantes, France
4
CHU Orléans
Orléans, France