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NCT00434655 Clinical Trial

Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

Morbid Obesity Clinical Trial

Official title:
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00434655
Other study ID # 07-010
Secondary ID
Status Completed
Phase Phase 3
First received February 9, 2007
Last updated December 14, 2009
Start date January 2008
Est. completion date December 2009

Study information
Verified date December 2009
Source North Texas Veterans Healthcare System
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Description:

This is a bariatric surgery Phase 3 prospective trial.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Laparoscopic restrictive procedure
Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.

Locations
Country Name City State
United States VA North Texas Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
North Texas Veterans Healthcare System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Short and long term clinical outcomes 5 years No
Secondary Metabolic outcomes 5 years No
Secondary Esophago-gastric physiology 2 years No
Secondary Hormonal physiology 5 years No
Secondary Procedure costs 5 years Yes
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