Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

February 9, 2007

Last Updated Date

August 18, 2009

Start Date ^ICMJE

January 2008

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Short and long term clinical outcomes [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Short and long term clinical outcomes

Change History

Complete list of historical versions of study NCT00434655 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Metabolic outcomes
Esophago-gastric physiology
Hormonal physiology
Procedure costs

Descriptive Information

Brief Title ^ICMJE

Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

Official Title ^ICMJE

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

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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Morbid Obesity

Intervention ^ICMJE

Procedure: Laparoscopic restrictive procedure

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00434655

Responsible Party

Esteban Varela MD,MPH, North Texas VA

Study ID Numbers ^ICMJE

07-010

Study Sponsor ^ICMJE

North Texas Veterans Healthcare System

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Esteban Varela, MD

VA North Texas

Information Provided By

North Texas Veterans Healthcare System

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP