Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)

Completed · Not applicable

Conditions studied: Morbid Obesity

In brief

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 bowel to bypass the stomach and duodenum. There are two anastomoses in this procedure: the gastrojejunostomy and the jejunojejunostomy. Potential complications after gastric bypass include gastrointestinal bleeding and leaks. Gastrointestinal bleeding can occur at any staple line including the gastrojejunostomy. Potential methods for prevention of postoperative gastrointestinal bleeding include oversewing of the anastomosis or the use of a smaller stapler height. We hypothesize that the use of staplers with smaller staple height will significantly result in a lower rate of staple line bleeding and possible leaks.

Key facts

Study ID

NCT00254072

Run by

University of California, Irvine

People needed

355

Starts

2007-01-01

Expected to finish

2009-04-01

Last updated by the study team

2010-02-18

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• BMI between 40-60 kg/m2
• BMI of 35 kg/m2 with comorbidities

You may not qualify if…

• 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.

Where it is running

• University of California, Irvine Medical Center — Orange, California, United States
• Tampa General Hospital- University of South Florida — Tampa, Florida, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• New York Presbyterian Hospital-Weill Cornell Medical Center — New York, New York, United States
• Ohio State University — Columbus, Ohio, United States
• UT Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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