- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00434655
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy
December 14, 2009 updated by: North Texas Veterans Healthcare System
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial
- The investigators aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with comorbidities or BMI > 40) in VETERANS.
- The investigators hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a bariatric surgery Phase 3 prospective trial.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75216
- VA North Texas
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Morbidly obese VETERANS ONLY (BMI>35 with comorbidities or BMI > 40)
- Age > 18 y/o
Exclusion Criteria:
- Pregnancy
- Severe uncontrolled medical or psychiatric conditions
- Previous bariatric surgery
- Multiple previous abdominal surgeries
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1 LAP BAND
|
Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
|
Experimental: 2 Sleeve gastrectomy
|
Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Short and long term clinical outcomes
Time Frame: 5 years
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Metabolic outcomes
Time Frame: 5 years
|
5 years
|
Esophago-gastric physiology
Time Frame: 2 years
|
2 years
|
Hormonal physiology
Time Frame: 5 years
|
5 years
|
Procedure costs
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Esteban Varela, MD, VA North Texas
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2009
Study Registration Dates
First Submitted
February 9, 2007
First Submitted That Met QC Criteria
February 9, 2007
First Posted (Estimate)
February 13, 2007
Study Record Updates
Last Update Posted (Estimate)
December 15, 2009
Last Update Submitted That Met QC Criteria
December 14, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-010 (Sponsor's Code)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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