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

Sponsor:	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:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective 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: 2 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
Study Completion Date:	December 2009
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 LAP BAND	Procedure: Laparoscopic restrictive procedure Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
Experimental: 2 Sleeve gastrectomy	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 trial.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434655

Locations

Sponsors and Collaborators

North Texas Veterans Healthcare System

Investigators

Principal Investigator:

Esteban Varela, MD

VA North Texas

More Information

No publications provided

Responsible Party:	Esteban Varela MD,MPH, North Texas VA
ClinicalTrials.gov Identifier:	NCT00434655 History of Changes
Other Study ID Numbers:	07-010
Study First Received:	February 9, 2007
Last Updated:	December 14, 2009
Health Authority:	United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:

Morbid obesity
Bariatric surgery
Obesity surgery
Gastric banding
Sleeve gastrectomy

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012