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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Hop Claude Huriez Chu Lille
RECRUITING
Lille
CHU de Lyon
RECRUITING
Lyon
CHU de Nantes
RECRUITING
Nantes
CHU Orléans
RECRUITING
Orléans
AP-HP Hôpital Bichat
RECRUITING
Paris
AP-HP Hôpital Georges Pompidou
RECRUITING
Paris
CHU de Poitiers
RECRUITING
Poitiers
CHU de Nancy
RECRUITING
Vandœuvre-lès-nancy
Contact Information
Primary
Robert CAIAZZO, MD,PhD
robert.caiazzo@chru-lille.fr
0320445962
Time Frame
Start Date: 2021-07-23
Estimated Completion Date: 2025-07
Participants
Target number of participants: 320
Treatments
Experimental: laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
Sham_comparator: laparoscopic Roux-en-Y gastric bypass (RYGB)
One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB)
Sponsors
Collaborators: Ministry of Health, France
Leads: University Hospital, Lille

This content was sourced from clinicaltrials.gov