Overview

This trial is active, not recruiting.

Condition obesity
Treatments laparoscopic mini-gastric bypass, procedure of reference in bariatric surgery
Sponsor Hospices Civils de Lyon
Start date May 2014
End date April 2018
Trial size 256 participants
Trial identifier NCT02139813, 2014.851

Summary

Several prospective trials and metaanalysis have demonstrated the superiority of bariatric surgery on the medical treatment of obesity. The Roux-en-Y Gastric ByPass (RYGBP) procedure has been practiced for more than 30 years, and is the procedure of choice for morbidly obese with metabolic disorders in most of the reference centers. Nevertheless, the RYGBP is a technically demanding procedure with a learning curve of more than 75 cases. The complication rate is around 10% in expert centers.

More recently another procedure has been described which seems as efficient on weight loss and co-morbidities as the RYGBP, with the advantage of being less technically difficult and less morbid, especially for multi-complicated obese and/or the super obese. It consists of a unique gastro-jejunal anastomosis between a long gastric pouch and a jejunal Omega loop. However, this procedure could be at risk of biliary reflux and anastomotic ulcers with dysplastic changes of the gastric and esophageal mucosa. As a result, the Omega loop bypass (OLB) has only been developed by a few teams and remains a controversial subject, particularly as only one monocentric randomized trial has compared it to the RYGBP, which is remains the gold standard. The first litterature results show similar or even better weight loss efficiency than RYGBP with a better feasibility. The early complication rate seems lower, but there are still insufficient data on long term morbidity and biliary reflux consequences.

By performing a randomized and prospective comparison of OLB to RYGBP, the aim of the investigators study is to analyze the weight loss efficiency, the morbidity and mortality, the feasibility, and the quality of life of both techniques, in order to validate the Omega loop bypass as a procedure of choice in bariatric surgery

Hypothesis :

The OLB, while being as efficient as RYGBP on weight loss and metabolic complications, could be less morbid.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Laparoscopic Mini-gastric bypass
laparoscopic mini-gastric bypass
The laparoscopic Omega Loop Bypass will consist of: a long gastric tube, stapled approximately 1.5 cm from the left of the lesser curvature of the antrum to the angle of His a narrow gastric tube will be calibrated to be approximately 1.5 cm wide an Omega loop of 200 cm a unique gastro-jejunal anatomosis of 200cm from the ligament of Treitz, using a linear stapler
(Active Comparator)
Procedure of reference in bariatric surgery
procedure of reference in bariatric surgery
The laparoscopic Roux-en-Y Gastric Bypass will consist of: a small gastric pouch (about 30cc) an antecolic alimentary limb a gastro-jejunal anastomosis using a linear stapler a 150cm long alimentary limb a 50cm biliary limb a latero-lateral jejuno-jejunal anastomosis closure of the mesenteric defects

Primary Outcomes

Measure
Weight loss assessment according to Excess BMI Loss percentage (EBL%)
time frame: 2 years after surgery

Secondary Outcomes

Measure
Weight loss according to absolute weight loss (aWL in kg), Excess Weight Loss percentage (EWL%), EBL%
time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Waist size reduction according to absolute waist size (in cm)
time frame: 1, 3, 6, 12, 18 and 24 months after surgery
Medical and surgical complication rates
time frame: 1, 12 and 24 months after surgery
Type and severity of complications
time frame: During the month following surgery (for early complications) and from one month to 24 months postoperatively (for late complications)
Operative time
time frame: Recorded on the day of surgery (Day 0)
Mean length of stay
time frame: Average period of 5 days from surgery (Day of surgery = D0) until the end of hospitalization, recorded on Visit 4 (Month1 +/- 10 days)
Patient's quality of life
time frame: The day before surgery (D-1) and 6, 12 and 24 months after surgery
Metabolic and lipid profile
time frame: During the period of inclusion (D-60 to D-2) and at 6, 12 and 24 months after surgery
Dumping syndrome and hypoglycemia symptoms
time frame: At 1, 3,6,12,18 and 24 months after surgery
Gastroesophageal reflux
time frame: The day before surgery (Day-1) and 6, 12, and 24 months after surgery
Modifications of the gastric and esophageal mucosa
time frame: 2 years after surgery
Frequency of diarrhea
time frame: The day before surgery (day-1) and 6, 12, and 24 months after surgery
Nutritional status
time frame: During the period of inclusion (D-60 to D-2) and 6, 12, and 24 months after surgery (The 24-hour steatorrhea will be quantified at 6 months).

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Aged between 18 and 65 years old - Morbid obesity with BMI ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 associated with one or more co-morbidities (type 2 diabetes, arterial hypertension, sleep apnea, dyslipidemia, arthritis) - Patient who has benefited from an upper GI endoscopy with biopsies - Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for a gastric bypass - 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 esophagitis on upper GI endoscopy (Los Angeles classification) - Severe gastroesophageal reflux disease (GERD), resistant to medical treatment - Presence of dysplastic modifications of the gastric mucosa or a history of gastric cancer, on upper gastrointestinal endoscopy. - Presence of Helicobacter Pylori resistant to medical treatment - Presence of an unhealed gastro-duodenal ulcer or an ulcer diagnosed less than 2 months previously - History of previous bariatric surgery (gastric band, sleeve gastrectomy, vertical banded gastroplasty) - Presence of a severe and evolutive life threatening pathology, unrelated to obesity - Presence of chronic diarrhea (≥ 3 loose or liquid stools per day, over a period of more than 4 weeks) - Pregnancy or desire to be pregnant during the study - Binge eating disorders or other eating disorders according to DSM V criteria - Mentally unbalanced patients, 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

Additional Information

Official title Prospective Multicentric Randomized Trial of Efficiency and Safety of Laparoscopic Omega Loop Bypass Versus Roux-en-Y Gastric Bypass
Principal investigator Maud ROBERT, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.