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Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery

NCT ID: NCT00361985

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-07-31

Brief Summary

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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

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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).

Conditions

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Anastomotic Stricture Morbid Obesity

Keywords

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Gastric bypass Anastomotic stricture Morbid obesity Bariatric surgery Omeprazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Nexium group

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

Esomeprazole 40mg once daily orally.

Esomeprazole

Intervention Type DRUG

Esomeprazole 40mg once daily orally

Interventions

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Esomeprazole

Esomeprazole 40mg once daily orally.

Intervention Type DRUG

Esomeprazole

Esomeprazole 40mg once daily orally

Intervention Type DRUG

Other Intervention Names

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Nexium Nexium

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Weill Cornell Medical College

Principal Investigators

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Gregory F. Dakin, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Medical College of Cornell Unversity

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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0511008254

Identifier Type: -

Identifier Source: org_study_id