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”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: January 2011

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.

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • Esomeprazole 40mg once daily orally.
• Drug: Esomeprazole
  • Esomeprazole 40mg once daily orally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Nexium group

Primary Measures

• Gastrojejunal stricture
  • Time Frame: 6 months after surgery
    Safety Issue?: No

Secondary Measures

• Gastrojejunal ulcer
  • Time Frame: 6 months after surgery
    Safety Issue?: No

Inclusion Criteria:

• Any patient who satisfies the requirements of the Weill-Cornell Weight Loss Surgery program to undergo laparoscopic Roux-en-Y gastric bypass surgery as treatment for morbid obesity.

Exclusion Criteria:

• Patients with a history of ulcer disease, patients taking chronic acid suppression medicine, and patients taking NSAIDS.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Weill Medical College of Cornell University

Overall Clinical Trial Officials and Contacts

Gregory F. Dakin, MD Principal Investigator Weill Medical College of Cornell University  

Overall Contact: Gregory F. Dakin, MD 212-746-5294 grd9006@med.cornell.edu

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361985

Study ID Number: 0511008254

ClinicalTrials.gov Identifier: NCT00361985

Health Authority: United States: Institutional Review Board