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
• 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

• Morbid Obesity
• Obesity, Morbid

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