Morbid Obesity Clinical Trial
Official title:
Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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