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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 355
- Locations
- 6
- Primary Endpoint
- Number of Participants With Postoperative Gastrointestinal Hemorrhage
Study Overview
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:
- 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
- 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
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •BMI between 40-60 kg/m2
- •BMI of 35 kg/m2 with comorbidities
Exclusion Criteria
- •large abdominal ventral hernia
- •large hiatal hernia,
- •history of liver cirrhosis
- •history of venous thrombosis or pulmonary embolism, coagulopathy or
- •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.
Arms & Interventions
Smaller Stapler
3.5 mm Circular Stapler
Intervention: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass (Procedure)
Larger Stapler
4.8 mm Circular Stapler
Intervention: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass (Procedure)
Outcomes
Primary Outcomes
Number of Participants With Postoperative Gastrointestinal Hemorrhage
Time Frame: 30 days
Secondary Outcomes
No secondary outcomes reported