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ACTIVE NOT RECRUITING
NCT04915014
NA

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

Sponsor: University Hospital, Lille

View on ClinicalTrials.gov

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 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.

Official title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2021-07-23

Completion Date

2026-07

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

PROCEDURE

sleeve gastrectomy with transit bipartition (SG +TB)

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.

PROCEDURE

Roux-en-Y gastric bypass (RYGB)

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.

Locations (8)

Hop Claude Huriez Chu Lille

Lille, France

CHU de Lyon

Lyon, France

CHU de Nantes

Nantes, France

CHU Orléans

Orléans, France

AP-HP Hôpital Bichat

Paris, France

AP-HP Hôpital Georges Pompidou

Paris, France

CHU de Poitiers

Poitiers, France

CHU de Nancy

Vandœuvre-lès-Nancy, France