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

NCT04915014 | Active Not Recruiting DMC

• 3 other identifiers: 2020_102020-A02656-33PHRC-19-031
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Severe Obesity

Keywords

Severe obesity; Type 2 diabetes; Metabolic syndrome; Surgery; Malnutrition

Outcome Measures

Primary Outcomes (1)

• The Excess Weight Loss percentage (EWL%)

  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

  at 2 years after surgery

Secondary Outcomes (16)

• Change nutritional status assessment

  from baseline (before surgery) to 24 months after surgery

• Change in liver status assessment

  from baseline (before surgery) to 24 months after surgery

• Change in vitamins status assessment

  from baseline (before surgery) to 24 months after surgery

• Change in mineral status assessment

  from baseline (before surgery) to 24 months after surgery

• 24-hour steatorrhea quantified at 6 months

  At 6 months

Study Arms (2)

laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

EXPERIMENTAL

One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

Procedure: sleeve gastrectomy with transit bipartition (SG +TB)

laparoscopic Roux-en-Y gastric bypass (RYGB)

SHAM COMPARATOR

One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB)

Procedure: Roux-en-Y gastric bypass (RYGB)

Interventions

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.

laparoscopic Roux-en-Y gastric bypass (RYGB)

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.

laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (8)

Hop Claude Huriez Chu Lille

Lille, 59037, France

Location

CHU de Lyon

Lyon, France

Location

CHU de Nantes

Nantes, France

Location

CHU Orléans

Orléans, France

Location

AP-HP Hôpital Bichat

Paris, France

Location

AP-HP Hôpital Georges Pompidou

Paris, France

Location

CHU de Poitiers

Poitiers, France

Location

CHU de Nancy

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2; Metabolic Syndrome; Malnutrition

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Robert CAIAZZO, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: June 7, 2021
• Study Start: July 23, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

FR (8)