Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy
Phase 3
Completed
- Conditions
- Morbid Obesity
- Registration Number
- NCT00434655
- Lead Sponsor
- North Texas Veterans Healthcare System
- Brief Summary
* 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.
- Detailed Description
This is a bariatric surgery Phase 3 prospective trial.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Short and long term clinical outcomes 5 years
- Secondary Outcome Measures
Name Time Method Metabolic outcomes 5 years Esophago-gastric physiology 2 years Hormonal physiology 5 years Procedure costs 5 years
Trial Locations
- Locations (1)
VA North Texas
🇺🇸Dallas, Texas, United States
VA North Texas🇺🇸Dallas, Texas, United States