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Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic restrictive procedure
Sponsored by
North Texas Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid obesity, Bariatric surgery, Obesity surgery, Gastric banding, Sleeve gastrectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA North Texas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1 LAP BAND

2 Sleeve gastrectomy

Arm Description

Outcomes

Primary Outcome Measures

Short and long term clinical outcomes

Secondary Outcome Measures

Metabolic outcomes
Esophago-gastric physiology
Hormonal physiology
Procedure costs

Full Information

First Posted
February 9, 2007
Last Updated
December 14, 2009
Sponsor
North Texas Veterans Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT00434655
Brief Title
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy
Official Title
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy: A Prospective Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
North Texas Veterans Healthcare System

4. Oversight

5. Study Description

Brief 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.
Detailed Description
This is a bariatric surgery Phase 3 prospective trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid obesity, Bariatric surgery, Obesity surgery, Gastric banding, Sleeve gastrectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 LAP BAND
Arm Type
Active Comparator
Arm Title
2 Sleeve gastrectomy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic restrictive procedure
Intervention Description
Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
Primary Outcome Measure Information:
Title
Short and long term clinical outcomes
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Metabolic outcomes
Time Frame
5 years
Title
Esophago-gastric physiology
Time Frame
2 years
Title
Hormonal physiology
Time Frame
5 years
Title
Procedure costs
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esteban Varela, MD
Organizational Affiliation
VA North Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States

12. IPD Sharing Statement

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Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

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