Omega Loop Versus Roux-en-Y Gastric Bypass

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.

Conditions

• Obesity

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

• Hospices Civils de Lyon

  lead OTHER

Principal Investigators

• Maud ROBERT, MD · Service de Chirurgie Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon - France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-31

Primary Completion

2018-03-31

Completion

2018-03-31

Countries

• France

Study Locations