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| Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy |
| Current status of trial | Not yet recruiting |
| Sponsors and collaborators | Hadassah Medical Organization Carmel Medical Center |
| Information provided by | Hadassah Medical Organization |
| ClinicalTrials.gov identifier | NCT00667706 |
| Purpose | 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. |
| Condition(s) | Morbid Obesity |
| Intervention(s) | Procedure: laparoscopic operation Sleeve Gastrectomy Procedure: laparoscopic operation Roux-en-Y Gastric bypass |
| Phase | Phase IV |
| Study type and design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Official title | Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy |
| Primary outcome | weight loss 5 years No |
| Secondary outcome | 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 No |
| Study start | April 2008 |
| Minimum age | 18 Years |
| Maximum age | 80 Years |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - Adult patients with morbid obesity Exclusion Criteria: - Pregnancy, - Previous bariatric operation, - IBD, - Previous bowel or stomach surgery |
| Study ID numbers | GBVSSG-HMO-CTIL |
| Last updated | April 25, 2008 |
| Record first received | April 16, 2008 |
| ClinicalTrials.gov identifier | NCT00667706 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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