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

Morbid Obesity Clinical Trial

— EEA-LGB  

Official title:

Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)a Prospective Randomized Comparison of the 3.5 mm vs 4.8 mm Circular Stapler for Creation of the Gastrojejunostomy in Prevention of Staple Line Hemorrhage During Laparoscopic Gastric Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00254072
• Other study ID #: HS 2005 4474
• Secondary ID: SPA 38461
• Status: Completed
• Phase: N/A
• First received: October 31, 2005
• Last updated: February 11, 2010
• Start date: January 2007
• Est. completion date: April 2009

Study information

• Verified date: February 2010
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	United States Surgical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Postoperative Gastrointestinal Hemorrhage		30 days	Yes