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

This study has been withdrawn prior to enrollment.

(Insufficient enrollment)

Sponsor:

Collaborator:

AstraZeneca

Information provided by:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT00361985

First received: August 7, 2006

Last updated: May 7, 2010

Last verified: May 2010

History of Changes

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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:

Gastrojejunal stricture [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gastrojejunal ulcer [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

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
Experimental: 1 Nexium group	Drug: Esomeprazole Esomeprazole 40mg once daily orally. Other Name: Nexium Drug: Esomeprazole Esomeprazole 40mg once daily orally Other Name: Nexium

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).

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361985

Locations

United States, New York
Weill Medical College of Cornell Unversity
New York, New York, United States, 10021

Sponsors and Collaborators

Weill Medical College of Cornell University

AstraZeneca

Investigators

Principal Investigator:

Gregory F. Dakin, MD

Weill Medical College of Cornell University

More Information

No publications provided

Responsible Party:	Gregory Dakin, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT00361985 History of Changes
Other Study ID Numbers:	0511008254
Study First Received:	August 7, 2006
Last Updated:	May 7, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

Gastric bypass
Anastomotic stricture
Morbid obesity
Bariatric surgery
Omeprazole

Additional relevant MeSH terms:

Obesity
Obesity, Morbid
Constriction, Pathologic
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Pathological Conditions, Anatomical

Omeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013

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