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

This study has been completed.
Sponsor:
Collaborator:
United States Surgical
Information provided by:
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00254072
First received: October 31, 2005
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

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: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants With Postoperative Gastrointestinal Hemorrhage [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Enrollment: 355
Study Start Date: January 2007
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Smaller Stapler
3.5 mm Circular Stapler
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.
Other Names:
  • Covidien small 3.5 mm Circular Stapler
  • Covidien large 4.8 mm Circular Stapler
Active Comparator: Larger Stapler
4.8 mm Circular Stapler
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.
Other Names:
  • Covidien small 3.5 mm Circular Stapler
  • Covidien large 4.8 mm Circular Stapler

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

    • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254072

Locations
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
United States, Florida
Tampa General Hospital- University of South Florida
Tampa, Florida, United States, 33601
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, New York
New York Presbyterian Hospital-Weill Cornell Medical Center
New York, New York, United States, 10021
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210-1228
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390-9156
Sponsors and Collaborators
University of California, Irvine
United States Surgical
Investigators
Principal Investigator: Ninh T Nguyen, MD University of California, Irvine
  More Information

No publications provided

Responsible Party: Ninh T. Nguyen, MD /Chief, Division of Gastrointestinal Surgery, University of California, Irvine Medical Center
ClinicalTrials.gov Identifier: NCT00254072     History of Changes
Other Study ID Numbers: HS 2005 4474, SPA 38461
Study First Received: October 31, 2005
Results First Received: November 5, 2009
Last Updated: February 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Morbid Obesity
Laparoscopic Gastric Bypass
Staple Line Hemorrhage

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014