Comparing two surgical methods for treating severe obesity
Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)
This study is testing whether a new type of weight loss surgery called sleeve gastrectomy with transit bipartition works better than the traditional Roux-en-Y gastric bypass for people with severe obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Lille Academic / other |
| Locations | 8 sites (Lille and 7 other locations) |
| Trial ID | NCT04915014 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of sleeve gastrectomy with transit bipartition (SG+TB) versus Roux-en-Y gastric bypass (RYGB) in patients with severe obesity. The study aims to determine which surgical approach leads to better weight loss outcomes and fewer complications, particularly in super-obese patients. Participants will undergo a thorough evaluation to assess their eligibility for either surgical procedure, focusing on those with a BMI of 40 kg/m2 or higher, or 35 kg/m2 with associated comorbidities. The trial will also monitor long-term follow-up to assess weight loss and the incidence of malnutrition.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with a BMI of 40 kg/m2 or higher, or 35 kg/m2 with obesity-related health issues, who have not had prior bariatric surgery.
Not a fit: Patients with a current BMI over 60 kg/m2 or those with a history of previous bariatric surgery, other than sleeve gastrectomy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective surgical option for patients with severe obesity, leading to improved weight loss and reduced complications.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, but this specific comparison of SG+TB and RYGB is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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 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
Where this trial is running
Lille and 7 other locations
- Hop Claude Huriez Chu Lille — Lille, France (Recruiting)
- CHU de Lyon — Lyon, France (Recruiting)
- CHU de Nantes — Nantes, France (Recruiting)
- CHU Orléans — Orléans, France (Recruiting)
- AP-HP Hôpital Bichat — Paris, France (Recruiting)
- AP-HP Hôpital Georges Pompidou — Paris, France (Recruiting)
- CHU de Poitiers — Poitiers, France (Recruiting)
- CHU de Nancy — Vandœuvre-lès-Nancy, France (Recruiting)
Study contacts
- Principal investigator: Robert CAIAZZO, MD,PhD — University Hospital, Lille
- Study coordinator: Robert CAIAZZO, MD,PhD
- Email: robert.caiazzo@chru-lille.fr
- Phone: 0320445962
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.