N/A
Completed N=355
Evaluation of Endostapled Anastomoses for Laparoscopic Gastric Bypass (EEA-LGB)
Source: ClinicalTrials.gov NCT00254072 ↗Enrolled (actual)
355
Serious AEs
5.4%
Results posted
Jan 2010
Primary outcomePrimary: Number of Participants With Postoperative Gastrointestinal Hemorrhage — 13; 39 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Gastrointestinal Hemorrhage |
13; 39 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00254072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.