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

University of California Irvine (UCI)

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT00254072

HS 2005 4474

SPA 38461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 355 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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355 participants in 2 patient groups

Smaller Stapler

Active Comparator group

Description:

3.5 mm Circular Stapler

Treatment:

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

Larger Stapler

Active Comparator group

Description:

4.8 mm Circular Stapler

Treatment:

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