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Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

NCT ID: NCT00519441

Last Updated: 2012-08-15

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

Brief Summary

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Patients who have had laparoscopic surgery for the treatment of achalasia will be asked to have pH studies done in order to determine is these patients suffer from reflux after surgery.

Detailed Description

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The purpose of this study is to determine if patients who have laparoscopic Heller myotomies for the treatment of achalasia suffer from reflux after the surgery. Patients at our institution who have had surgery for achalasia will be asked to have pH studies done to determine whether or not these patients have reflux.

Conditions

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Reflux

Keywords

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laparoscopic Heller myotomy, achalasia, reflux

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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I

All patients in the study will have pH studies done in order to determine the degree of reflux after laparoscopic Heller myotomies.

Group Type OTHER

pH study

Intervention Type OTHER

All patients will have 48 hour pH study

Interventions

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pH study

All patients will have 48 hour pH study

Intervention Type OTHER

Other Intervention Names

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Bravo

Eligibility Criteria

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Inclusion Criteria

* Patients who have had laparoscopic Heller myotomies for the treatment of achalasia

Exclusion Criteria

* Patients under the age of 18 will not be included
* Patients who are receiving anti-reflux therapy will not be included
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kenneth Luberice

OTHER

Sponsor Role lead

Responsible Party

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Kenneth Luberice

Clinical Research Coordinator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sarah M Cowgill, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Harbourside Medical Tower

Tampa, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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104802

Identifier Type: -

Identifier Source: org_study_id