Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy - Full Text View

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

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

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

No publications provided

Responsible Party:	North Texas VA ( Esteban Varela MD,MPH )
Study ID Numbers:	07-010
Study First Received:	February 9, 2007
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00434655 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:

Morbid obesity
Bariatric surgery
Obesity surgery
Gastric banding
Sleeve gastrectomy

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders

Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on July 02, 2009