Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
NCT ID: NCT00667706
Last Updated: 2008-04-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2008-04-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Patients who will undergo Laparoscopic Sleeve Gastrectomy
laparoscopic operation Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy will be performed employing a 5-6 trocar technique, and includes gastric resection starting 4-5 cm proximal to the pylorus, using a 38 fr. Bougie and endoscopic stapler with blue and green load.
2
Patients who will undergo Laparoscopic Roux-en-Y Gastric Bypass
laparoscopic operation Roux-en-Y Gastric bypass
Divided LRYGB will employ 5-7 trocars technique, and includes stapled jejunojejunostomy 30-50 cm distal to the Treitz ligament, gastric pouch of 20 cc., and antecolic, antegastric gastrojejunal anastomosis, either two layered hand-sawn, GIA, or EEA-25 -stapled, at surgeons preference. The length of the Roux limb will be 100 centimeters or 150 centimeters in patients with BMI of \<50, and \>50, respectively.
Interventions
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laparoscopic operation Sleeve Gastrectomy
Laparoscopic Sleeve Gastrectomy will be performed employing a 5-6 trocar technique, and includes gastric resection starting 4-5 cm proximal to the pylorus, using a 38 fr. Bougie and endoscopic stapler with blue and green load.
laparoscopic operation Roux-en-Y Gastric bypass
Divided LRYGB will employ 5-7 trocars technique, and includes stapled jejunojejunostomy 30-50 cm distal to the Treitz ligament, gastric pouch of 20 cc., and antecolic, antegastric gastrojejunal anastomosis, either two layered hand-sawn, GIA, or EEA-25 -stapled, at surgeons preference. The length of the Roux limb will be 100 centimeters or 150 centimeters in patients with BMI of \<50, and \>50, respectively.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Previous bariatric operation,
* IBD,
* Previous bowel or stomach surgery
18 Years
80 Years
ALL
No
Sponsors
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Carmel Medical Center
OTHER
Hadassah Medical Organization
OTHER
Responsible Party
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Hadassah Medical Organization
References
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Keidar A, Hershkop KJ, Marko L, Schweiger C, Hecht L, Bartov N, Kedar A, Weiss R. Roux-en-Y gastric bypass vs sleeve gastrectomy for obese patients with type 2 diabetes: a randomised trial. Diabetologia. 2013 Sep;56(9):1914-8. doi: 10.1007/s00125-013-2965-2. Epub 2013 Jun 14.
Other Identifiers
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GBVSSG-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id