Clinical trial

Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04915014

Active, not recruitingNot applicableInterventional

What this study is about

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 during long-term follow-up. Sleeve Gastrectomy (SG) has become the most performed intervention either worldwide or in France, where SG represents more than 60% of bariatric interventions and 114,817 patients operated between 2013 and 2016. Maximum Excess weight loss (%EWL) after SG is obtained at one-year post surgery. Then it has been largely reported in the literature that patients could present mild, moderate or important (notably in the super obese patients) weight regain associated with comorbidity relapse motivating redo surgery. Like in revisional surgery, operating super-obese patient (BMI ≥50 kg/m2) is a challenge. It has been shown that achieving significant weight loss was more difficult in patients with a BMI ≥ 50 compared to lower BMIs.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionSevere Obesity

Full registry 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

Treatments and study arms

sleeve gastrectomy with transit bipartition (SG +TB)

Procedure

In case of a first intention procedure, a typical sleeve gastrectomy is performed, calibrated on a 36 French bougie, stapling starting 4 to 6 cm from the pylorus. Antecolic gastroileal anastomosis is performed 250 cm from the ileocecal transition, on the antrum using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 120 cm from the ileocecal junction. Thus, alimentary limb is 130cm and common limb 120cm.

Roux-en-Y gastric bypass (RYGB)

Procedure

A small gastric pouch (30 cc) is performed. Antecolic gastroileal anastomosis is performed 200 cm from the Treitz junction, using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 50 cm from the Treitz junction. Thus, alimentary limb is 150cm and biliary limb 50cm.

Primary outcomes

The Excess Weight Loss percentage (EWL%)at 2 years after surgery

The Excess Weight Loss percentage (EWL%) calculated with the following formula: ((weight at 2 years visit - initial weight (kg)) / (initial weight - ideal weight)) X 100 Ideal weight defined as the weight corresponding to a BMI = 25 kg/m2. Initial weight defined as preoperative weight at V1. All weights are expressed in kg