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.

Condition	Intervention
Morbid Obesity	Procedure: Laparoscopic Gastric Bypass

Further study details as provided by University of California, Irvine:

Expected Total Enrollment:  360

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 the gastrojejunostomy can be potentially life threatening and ranged from 1% to 2%.

HYPOTHESES:

The smaller circular stapler may be associated with a lower rate of intraoperative intraluminal bleeding and postoperative gastrointestinal bleeding than the larger one.

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

1. BMI between 40-60 kg/m2
2. BMI of 35 kg/m2 with comorbidities

Exclusion Criteria:

1. large abdominal ventral hernia
2. large hiatal hernia,
3. history of liver cirrhosis
4. history of venous thrombosis or pulmonary embolism, coagulopathy or
5. Pregnant women

Please refer to this study by ClinicalTrials.gov identifier  NCT00254072

Allen A Sabio, BS      714-456-7367  Ext. 7367    sabioa@uci.edu

California
      University of California, Irvine Medical Center, Orange,  California,  92868,  United States
Florida
      Tampa General Hospital- University of South Florida, Tampa,  Florida,  33601,  United States
Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States
New York
      New York Presbyterian Hospital-Weill Cornell Medical Center, New York,  New York,  10021,  United States
Ohio
      Ohio State University, Columbus,  Ohio,  43210-1228,  United States
Texas
      UT Southwestern Medical Center, Dallas,  Texas,  75390-9156,  United States

Study chairs or principal investigators

Ninh T Nguyen, MD,  Principal Investigator,  University of California, Irvine   

Study ID Numbers:  HS 2005 4474; SPA 38461
Last Updated:  December 19, 2005
Record first received:  October 31, 2005
ClinicalTrials.gov Identifier:  NCT00254072
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10