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| Sponsors and Collaborators: |
Weill Medical College of Cornell University AstraZeneca |
|---|---|
| Information provided by: | Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00361985 |
Purpose
The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric bypass surgery for morbid obesity.
| Condition | Intervention | Phase |
|---|---|---|
|
Anastomotic Stricture Morbid Obesity |
Drug: Esomeprazole |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized, Prospective, Double-Blind Trial of PPI vs Placebo in Prevention of Gastrojejunal Strictures After Laparoscopic Roux-en-Y Gastric Bypass for Morbid Obesity |
| Estimated Enrollment: | 400 |
| Study Start Date: | January 2008 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Nexium group
|
Drug: Esomeprazole
Esomeprazole 40mg once daily orally.
Drug: Esomeprazole
Esomeprazole 40mg once daily orally
|
Laparoscopic Roux-en-Y gastric bypass (LYRGB) has been shown to be a safe and effective procedure for the treatment of morbid obesity. However, a common early complication of LYRGB is stricture at the gastrojejunal (GJ) anastomosis, occurring in 4% - 27% of patients, usually within the third post-operative month. This complication usually presents with progressive dysphagia leading to daily vomiting. Endoscopic balloon dilation is the treatment of choice for this complication, and multiple dilations are often required to provide complete resolution.
The etiology of GJ anastomotic strictures is unknown and is probably multi-factorial. Some investigators hypothesize that ischemia or non-ischemia-related excessive scar formation is the cause of stricture. The method of construction of the anastomosis as well seems to have an impact, as circular stapled anastomoses may have higher rates of stricture than linear staplers or completely hand-sewn anastomoses. The route of the Roux limb (antecolic vs retrocolic) does not appear to affect this complication.
Several investigators have demonstrated little acid production in the gastric bypass pouch. Despite this data, acid secretion has been hypothesized as a predominant factor in the development of GJ stricture. This hypothesis is supported in part by the frequent finding of ulcers at the site of stricture in up to 55% of patients. The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce GJ anastomosis stricture rate.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Gregory F. Dakin, MD | 212-746-5294 | grd9006@med.cornell.edu |
| United States, New York | |
| Weill Medical College of Cornell Unversity | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Gregory Dakin, MD 212-746-5294 grd9006@med.cornell.edu | |
| Principal Investigator: | Gregory F. Dakin, MD | Weill Medical College of Cornell University |
More Information
| Responsible Party: | Weill Cornell Medical College ( Gregory Dakin, MD ) |
| Study ID Numbers: | 0511008254 |
| Study First Received: | August 7, 2006 |
| Last Updated: | April 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00361985 |
| Health Authority: | United States: Institutional Review Board |
|
Gastric bypass Anastomotic stricture Morbid obesity Bariatric surgery Omeprazole |
|
Pathological Conditions, Anatomical Body Weight Signs and Symptoms Obesity Omeprazole |
Nutrition Disorders Overweight Overnutrition Constriction, Pathologic Obesity, Morbid |
|
Molecular Mechanisms of Pharmacological Action Therapeutic Uses Anti-Ulcer Agents |
Gastrointestinal Agents Enzyme Inhibitors Pharmacologic Actions |
