Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

December 14, 2009 updated by: North Texas Veterans Healthcare System

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

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a bariatric surgery Phase 3 prospective trial.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75216
        • VA North Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Short and long term clinical outcomes
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Metabolic outcomes
Time Frame: 5 years
5 years
Esophago-gastric physiology
Time Frame: 2 years
2 years
Hormonal physiology
Time Frame: 5 years
5 years
Procedure costs
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

North Texas Veterans Healthcare System

Investigators

  • Principal Investigator: Esteban Varela, MD, VA North Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

February 9, 2007

First Submitted That Met QC Criteria

February 9, 2007

First Posted (Estimate)

February 13, 2007

Study Record Updates

Last Update Posted (Estimate)

December 15, 2009

Last Update Submitted That Met QC Criteria

December 14, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-010 (Sponsor's Code)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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