Status:
COMPLETED
Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
United States Surgical Corporation
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Laparoscopic gastric bypass surgery is a common procedure being performed for the treatment of morbid obesity. The procedure consists of a creation of a small gastric pouch and rerouting the small bow...
Detailed Description
RATIONALE: 1. Gastrointestinal (GI) bleeding can occur in up to 4% of cases. GI bleeding is associated with significant morbidity which may include transfusion and possible re-operation 2. Leaks at t...
Eligibility Criteria
Inclusion
- BMI between 40-60 kg/m2
- BMI of 35 kg/m2 with comorbidities
Exclusion
- large abdominal ventral hernia
- large hiatal hernia,
- history of liver cirrhosis
- history of venous thrombosis or pulmonary embolism, coagulopathy or
- Pregnant women
- All physician, hospital, surgery, and laboratory costs will be billed to the subject or their insurance carriers as customary. The 3.5mm circular stapler is an FDA approved product and it will also be billed to the subject or insurer in the customary fashion.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT00254072
Start Date
January 1 2007
End Date
April 1 2009
Last Update
February 18 2010
Active Locations (6)
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1
University of California, Irvine Medical Center
Orange, California, United States, 92868
2
Tampa General Hospital- University of South Florida
Tampa, Florida, United States, 33601
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021