Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
Primary Purpose
Morbid Obesity
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
laparoscopic operation Sleeve Gastrectomy
laparoscopic operation Roux-en-Y Gastric bypass
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
Inclusion Criteria:
- Adult patients with morbid obesity
Exclusion Criteria:
- Pregnancy,
- Previous bariatric operation,
- IBD,
- Previous bowel or stomach surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Patients who will undergo Laparoscopic Sleeve Gastrectomy
Patients who will undergo Laparoscopic Roux-en-Y Gastric Bypass
Outcomes
Primary Outcome Measures
weight loss
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00667706
First Posted
April 16, 2008
Last Updated
April 25, 2008
Sponsor
Hadassah Medical Organization
Collaborators
Carmel Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00667706
Brief Title
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
Official Title
Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hadassah Medical Organization
Collaborators
Carmel Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients who will undergo Laparoscopic Sleeve Gastrectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Patients who will undergo Laparoscopic Roux-en-Y Gastric Bypass
Intervention Type
Procedure
Intervention Name(s)
laparoscopic operation Sleeve Gastrectomy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic operation Roux-en-Y Gastric bypass
Intervention Description
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.
Primary Outcome Measure Information:
Title
weight loss
Time Frame
5 years
Secondary Outcome Measure Information:
Title
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
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients with morbid obesity
Exclusion Criteria:
Pregnancy,
Previous bariatric operation,
IBD,
Previous bowel or stomach surgery
12. IPD Sharing Statement
Citations:
PubMed Identifier
23765186
Citation
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.
Results Reference
derived
Learn more about this trial
Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy
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