N Texas Band study looking for obese VETERANS

[Guest guest]

Please pass this on to anyone you know (male or female veterans) who

may be interested.

Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve

Gastrectomy

This study is currently recruiting participants.

Verified by North Texas Veterans' Healthcare System, April 2008

Sponsored by: North Texas Veterans' Healthcare System

Information provided by: North Texas Veterans' Healthcare System

ClinicalTrials. gov Identifier: NCT00434655

Purpose

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.

Condition Intervention Phase

Morbid Obesity

Procedure: Laparoscopic restrictive procedure

Phase III

MedlinePlus related topics: Obesity

U.S. FDA Resources

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:

Short and long term clinical outcomes [ Time Frame: 5 years ] [

Designated as safety issue: No ]

Secondary Outcome Measures:

Metabolic outcomes [ Time Frame: 5 years ] [ Designated as safety

issue: No ]

Esophago-gastric physiology [ Time Frame: 5 years ] [ Designated as

safety issue: No ]

Hormonal physiology [ Time Frame: 5 years ] [ Designated as safety

issue: No ]

Procedure costs [ Time Frame: 5 years ] [ Designated as safety issue:

Yes ]

Estimated Enrollment: 40

Study Start Date: January 2008

Estimated Study Completion Date: December 2012

Estimated Primary Completion Date: December 2010 (Final data

collection date for primary outcome measure)

Arms Assigned Interventions

1 LAP BAND: Active Comparator Procedure: Laparoscopic restrictive

procedure

Morbidly Obese VETERANS will receive one of two laparoscopic

bariatric restrictive procedures.

2 Sleeve gastrectomy: Experimental Procedure: Laparoscopic

restrictive procedure

Morbidly Obese VETERANS will receive one of two laparoscopic

bariatric restrictive procedures.

Detailed Description:

This is a bariatric surgery Phase 3 prospective randomized trial.

Eligibility

Ages Eligible for Study: 18 Years to 65 Years

Genders Eligible for Study: Both

Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials. gov identifier:

NCT00434655

Contacts

Contact: Tammy Nguyen, MT 214-857-1521

tammy.nguyen@ va.gov

Locations

United States, Texas

VA North Texas Recruiting

Dallas, Texas, United States, 75216

Contact: Tammy Nguyen, MT 214-857-1521

tammy.nguyen@ va.gov

Principal Investigator: Esteban Varela, MD

Sponsors and Collaborators

North Texas Veterans' Healthcare System

Investigators

Principal Investigator: Esteban Varela, MD VA North

Texas

More Information

Responsible Party: North Texas VA ( Esteban Varela MD,MPH )

Study ID Numbers: 07-010

First Received: February 9, 2007

Last Updated: July 28, 2008

ClinicalTrials. gov Identifier: NCT00434655

Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:

Morbid obesity

Bariatric surgery

Obesity surgery

Gastric banding

Sleeve gastrectomy

ClinicalTrials. gov processed this record on November 20, 2008