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

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Postoperative Gastrointestinal Hemorrhage	30 days

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: United States Surgical Corporation

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): April 1, 2009
• Study Completion (ACTUAL): April 1, 2009

Study Registration Dates

• First Submitted: October 31, 2005
• First Submitted That Met QC Criteria: November 14, 2005
• First Posted (ESTIMATE): November 15, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): February 18, 2010
• Last Update Submitted That Met QC Criteria: February 11, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Morbid Obesity; Laparoscopic Gastric Bypass; Staple Line Hemorrhage
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: HS 2005 4474; SPA 38461