Clinical trial NCT00254072: Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid Obesity
Laparoscopic Gastric Bypass
Staple Line Hemorrhage
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: United States Surgical Corporation
First posted: 2005-11-15
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants With Postoperative Gastrointestinal Hemorrhage
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital- University of South Florida
state: Florida
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: New York
country: United States
facility: New York Presbyterian Hospital-Weill Cornell Medical Center
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of California, Irvine
name: Ninh T Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References: