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

University Hospital, Lille

Status: Enrolling

Conditions: Severe Obesity

Treatments: Procedure: Roux-en-Y gastric bypass (RYGB); Procedure: sleeve gastrectomy with transit bipartition (SG +TB)

Study type: Interventional

Funder types: Other

Identifiers

NCT04915014

PHRC-19-031 (Other Identifier)

2020_10

2020-A02656-33 (Other Identifier)

Details and patient eligibility

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.

Full 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 technical difficulties (high complication rate) and can be responsible for malnutrition (vitamin deficiencies, hypoalbuminemia...). That's why, in case of revisional surgery or for high BMI patients,laparoscopic Roux-en-Y gastric bypass (RYGBP) is still considered as the gold standard and is the most performed intervention. To obtain better weight loss safely,Santoro et al. promoted the sleeve gastrectomy with transit bipartition (SG+TB), a new intervention coupling a SG without interrupting pathway through the duodenum and preserving the pylorus and a long biliary limb RYGBP.

Hypothesis: Because there is no duodenal and jejunal exclusion, malnutrition is expected to be less frequent after SG+TB compared to BPD/DS. Its anastomosis on the antrum makes SG+TB easier to perform in super-obese patient than standard RYGB but more efficient in term of weight loss. Compared to BPD/DS or SADI which involves dissection of the duodenum and the confection of a duodenojejunostomy, SG+TB is also expected to be easier then safer.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

Experimental group

Description:

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

Treatment:

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

laparoscopic Roux-en-Y gastric bypass (RYGB)

Sham Comparator group

Description:

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

Treatment:

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