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

Not Applicable

Completed

• Conditions: Morbid Obesity
• Interventions: Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

• Registration Number: NCT00254072
• Lead Sponsor: University of California, Irvine

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 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.

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 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.

Study Timeline

• Study First Submitted: 2005-10-31
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-15
• Study Start: 2007-01
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Results First Submitted: 2009-11-05
• Results First Submitted QC: 2009-12-11
• Results First Posted: 2010-01-18
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-11
• Last Update Posted: 2010-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 355

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

   • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Larger Stapler	3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass	4.8 mm Circular Stapler
Smaller Stapler	3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass	3.5 mm Circular Stapler

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Gastrointestinal Hemorrhage	30 days

Trial Locations

Locations (6)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Tampa General Hospital- University of South Florida; 🇺🇸 Tampa, Florida, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of California, Irvine Medical Center; 🇺🇸 Orange, California, United States

New York Presbyterian Hospital-Weill Cornell Medical Center; 🇺🇸 New York, New York, United States