N/A N=355 Randomized Prevention

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

Morbid Obesity

Bottom Line

View on ClinicalTrials.gov: NCT00254072 ↗

Enrolled (actual)

355

Serious AEs

5.4%

Results posted

Jan 2010

Primary outcome: Primary: Number of Participants With Postoperative Gastrointestinal Hemorrhage — 13; 39 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 3.5 mm vs 4.8 mm Stapler During Laparoscopic Gastric Bypass (Procedure)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of California, Irvine
Primary completion: Apr 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Postoperative Gastrointestinal Hemorrhage	13; 39	—

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.

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.

View full record on ClinicalTrials.gov →

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.