Clinical trial NCT04915014: Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Obesity
Keywords: Severe obesity
Type 2 diabetes
Metabolic syndrome
Surgery
Malnutrition
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2021-06-07
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: The Excess Weight Loss percentage (EWL%)
timeFrame: at 2 years after surgery
Secondary outcomes:
measure: Change nutritional status assessment
timeFrame: from baseline (before surgery) to 24 months after surgery
measure: Change in liver status assessment
timeFrame: from baseline (before surgery) to 24 months after surgery
measure: Change in vitamins status assessment
timeFrame: from baseline (before surgery) to 24 months after surgery
measure: Change in mineral status assessment
timeFrame: from baseline (before surgery) to 24 months after surgery
measure: 24-hour steatorrhea quantified at 6 months
timeFrame: At 6 months
measure: Evolution of muscle mass assessed by bioelectrical impedance analysis
timeFrame: from baseline to 24 months after surgery
measure: Evolution of muscle mass assessed by grip strength test.
timeFrame: from baseline to 24 months after surgery
measure: Complications rate within 2 years according to Dindo-Clavien classification
timeFrame: within 2 years
measure: Length of hospital stay defined as the number of days of hospitalization
timeFrame: up to 2 week
measure: Evolution from baseline to 24 months after surgery of HbA1c level, HDL, LDL and triglycerides
timeFrame: from baseline to 24 months after surgery
measure: Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12
timeFrame: from baseline to 24 months
measure: Change of the GIQLI score
timeFrame: from baseline to 24 months after surgery
measure: Change of the SF36 scores
timeFrame: from baseline to 24 months after surgery
measure: Change in Sigstad questionnaire score (dumping syndrome).
timeFrame: from baseline to 24 months after surgery
measure: Change of food choices and preferences assessed by the Leeds Food Preference Questionnaire (LFPQ) score.
timeFrame: from baseline to 24 months after surgery
measure: Change of physical activity assessed by the International Physical Activity Index (IPAQ) score.
timeFrame: from baseline to 24 months after surgery
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
city: Lyon
country: France
facility: CHU de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Orléans
country: France
facility: CHU Orléans
city: Paris
country: France
facility: AP-HP Hôpital Bichat
city: Paris
country: France
facility: AP-HP Hôpital Georges Pompidou
city: Poitiers
country: France
facility: CHU de Poitiers
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy
Study officials:
affiliation: University Hospital, Lille
name: Robert CAIAZZO, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: