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OpenTrials
Completed

NCT Number: NCT00434655

Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy

* 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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA North Texas

Dallas, Texas, 75216, United States

About this study

This is a bariatric surgery Phase 3 prospective trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic restrictive procedure

Procedure

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

Primary outcomes

  1. Short and long term clinical outcomes

    Time frame: 5 years

Secondary outcomes

  1. Metabolic outcomes

    Time frame: 5 years

  2. Esophago-gastric physiology

    Time frame: 2 years

  3. Hormonal physiology

    Time frame: 5 years

  4. Procedure costs

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 13, 2007
Registry last updated
Dec 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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