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

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ClinicalTrials.gov Identifier: NCT00254072
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : January 18, 2010
Last Update Posted : February 18, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Morbid Obesity Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2007
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Postoperative Gastrointestinal Hemorrhage [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Corporation
Investigators
Principal Investigator: Ninh T Nguyen, MD University of California, Irvine
More Information

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
First Posted: November 15, 2005    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: February 18, 2010
Last Verified: February 2010

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

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