Omega Loop Versus Roux-en-Y Gastric Bypass
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

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.
    


Intervention name(s): Laparoscopic Mini-gastric bypass; Procedure of reference in bariatric surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity -; Bariatric surgery; Gastric bypass