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Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

NCT ID: NCT00434655

Last Updated: 2009-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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* 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

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This is a bariatric surgery Phase 3 prospective trial.

Conditions

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Morbid Obesity

Keywords

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Morbid obesity Bariatric surgery Obesity surgery Gastric banding Sleeve gastrectomy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 LAP BAND

Group Type ACTIVE_COMPARATOR

Laparoscopic restrictive procedure

Intervention Type PROCEDURE

Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.

2 Sleeve gastrectomy

Group Type EXPERIMENTAL

Laparoscopic restrictive procedure

Intervention Type PROCEDURE

Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.

Interventions

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Laparoscopic restrictive procedure

Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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North Texas VA

Principal Investigators

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Esteban Varela, MD

Role: PRINCIPAL_INVESTIGATOR

VA North Texas

Locations

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VA North Texas

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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07-010

Identifier Type: -

Identifier Source: org_study_id