Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

Phase 4

• Conditions: Morbid Obesity
• Interventions: Procedure: laparoscopic operation Sleeve Gastrectomy; Procedure: laparoscopic operation Roux-en-Y Gastric bypass

• Registration Number: NCT00667706
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss is now gaining popularity as a standalone procedure for the treatment of morbid obesity. It appears to be a technically easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good weight loss results, in some studies even comparable to the RYGB and Biliopancreatic Diversion with Duodenal Switch.

The mechanism of action is assumed to be purely restrictive, but some neurohumoral interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the medical and general quality of life or resolution of comorbidities.

The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been reported in the range that seems to be higher than for the purely restrictive procedures.

Our goal is to to compare the surgical and weight loss outcomes between the two procedures, their influence on resolution of common comorbidities and on quality of life change.

150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed evaluation and preoperative questionnaires will be used to obtain demographic and medical data, and quality of life will be assessed.

General metabolic and nutritional work up will be done, and will be reassessed at different intervals up to 5 years, in order to compare the short and long term results of the two procedures.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study Start: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-25
• Last Update Submitted: 2008-04-25
• Study First Posted: 2008-04-28
• Last Update Posted: 2008-04-28
• Primary Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adult patients with morbid obesity

Exclusion Criteria

• Pregnancy,
• Previous bariatric operation,
• IBD,
• Previous bowel or stomach surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	laparoscopic operation Sleeve Gastrectomy	Patients who will undergo Laparoscopic Sleeve Gastrectomy
2	laparoscopic operation Roux-en-Y Gastric bypass	Patients who will undergo Laparoscopic Roux-en-Y Gastric Bypass

Primary Outcome Measures

Name	Time	Method
weight loss	5 years

Secondary Outcome Measures

Name	Time	Method
short and long term complication rates, length of stay, need for re-operations efficiency of the procedure in inducing weigh loss and resolution of common co-morbidities	5 years