Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery
Primary Purpose
Anastomotic Stricture, Morbid Obesity
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Sponsored by
About this trial
This is an interventional prevention trial for Anastomotic Stricture focused on measuring Gastric bypass, Anastomotic stricture, Morbid obesity, Bariatric surgery, Omeprazole
Eligibility Criteria
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.
Sites / Locations
- Weill Medical College of Cornell Unversity
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Nexium group
Outcomes
Primary Outcome Measures
Gastrojejunal stricture
Secondary Outcome Measures
Gastrojejunal ulcer
Full Information
NCT ID
NCT00361985
First Posted
August 7, 2006
Last Updated
October 31, 2016
Sponsor
Weill Medical College of Cornell University
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT00361985
Brief Title
Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient enrollment
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
PLEASE NOTE: THIS STUDY DOES NOT PROVIDE SURGERY (APPROPRIATE INSURANCE COVERAGE IS REQUIRED).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anastomotic Stricture, Morbid Obesity
Keywords
Gastric bypass, Anastomotic stricture, Morbid obesity, Bariatric surgery, Omeprazole
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Nexium group
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
Esomeprazole 40mg once daily orally.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
Esomeprazole 40mg once daily orally
Primary Outcome Measure Information:
Title
Gastrojejunal stricture
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Gastrojejunal ulcer
Time Frame
6 months after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory F. Dakin, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell Unversity
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery
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