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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Smaller Stapler<br>3.5 mm Circular Stapler | Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass<br>* 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.<br>* Other names: Covidien large 4.8 mm Circular Stapler;|
| Active Comparator: Larger Stapler<br>4.8 mm Circular Stapler | Procedure: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass<br>* 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.<br>* Other names: Covidien large 4.8 mm Circular Stapler;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Laparoscopic Gastric Bypass, Staple Line Hemorrhage