Laparoscopic Gastric Banding Versus Sleeve Gastrectomy
This study is not yet open for patient recruitment.
Verified by North Texas Veterans' Healthcare System February 2007
| Sponsored by: |
North Texas Veterans' Healthcare System |
| Information provided by: |
North Texas Veterans' Healthcare System |
| ClinicalTrials.gov Identifier: |
NCT00434655 |
|
Purpose
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We aim to determine the clinical and metabolic outcomes of two available bariatric restrictive procedures: laparoscopic adjustable gastric banding and laparoscopic sleeve gastrectomy for the treatment of morbidly obesity(BMI>35 with comorbidities or BMI>40).
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We hypothesize that the short and long term outcomes between laparoscopic adjustable gastric banding and sleeve gastrectomy are similar.
| Condition |
Intervention |
Phase |
Morbid Obesity
|
Procedure: Laparoscopic restrictive procedure
|
Phase III
|
MedlinePlus
related topics:
Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Randomized Trial
Further study details as provided by North Texas Veterans' Healthcare System:
Primary Outcome Measures:
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Short and long term clinical outcomes
Secondary Outcome Measures:
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Metabolic outcomes
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Esophago-gastric physiology
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Hormonal physiology
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Procedure costs
Total Enrollment: 40
Study start: April 2007
-This is a bariatric surgery Phase 3 prospective randomized trial.
Eligibility
Ages Eligible for Study: 18 Years - 65 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
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Morbidly obese veterans ((BMI>35 with comorbidities or BMI>40)
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Age > 18 y/o
Exclusion Criteria:
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Pregnancy
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Severe uncontrolled medical or psychiatric conditions
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Previous bariatric surgery
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00434655
United States, Texas
VA North Texas, Dallas, Texas, 75216, United States
Esteban Varela, MD, Principal Investigator
Study chairs or principal investigators
Esteban Varela, MD, Principal Investigator, VA North Texas
More Information
Study ID Numbers: 07-010
Last Updated: February 9, 2007
Record first received: February 9, 2007
ClinicalTrials.gov Identifier:
NCT00434655
Health Authority: United States: Federal Government
