Status:
COMPLETED
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Lead Sponsor:
University of California, Irvine
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as "morbid obesity", is defined as being 100 pounds in excess of ideal body weight. Nonsurgical treatments for morbid o...
Detailed Description
RATIONALE: 1. Morbid obesity and its health consequences is increasing in the United States 2. Roux-en-Y GBP is an effective treatment for morbid obesity but can be associated with substantial morbid...
Eligibility Criteria
Inclusion
- Eligibility:
- Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities
- Good health status with acceptable operative risk (good cardiopulmonary function)
- Willingness to follow protocol requirements: Signing informed consent, follow-up, and completing protocol diagnostic tests
Exclusion
- Prior upper abdominal surgery except cholecystectomy
- Large abdominal ventral hernia
- Patients with hiatal hernia
- Inadequate prior medical management
- Lack of patient's motivation and contribution to long-term success
- Unacceptable operative risk
- Minors and pregnant women are excluded as these patients do not qualify for the bariatric procedures. Minors are not psychologically fit to undergo such surgery and pregnant women are excluded because of safety for the fetus.
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
197 Patients enrolled
Trial Details
Trial ID
NCT00247377
Start Date
October 1 2002
End Date
December 1 2009
Last Update
April 24 2023
Active Locations (1)
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1
Univeristy of California, Irvine, Medical Center
Orange, California, United States, 92868