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Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00519441
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : August 15, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Reflux Other: pH study

Detailed Description:
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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Gastroesophageal Reflux in Patients With Achalasia
Study Start Date : June 2007
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
I
All patients in the study will have pH studies done in order to determine the degree of reflux after laparoscopic Heller myotomies.
Other: pH study
All patients will have 48 hour pH study
Other Name: Bravo


Outcome Measures

Primary Outcome Measures :
  1. The objective of this study is to determine the degree of post-operative reflux in patients who have had laparoscopic Heller myotomies for the treatment of achalasia. [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519441


Locations
United States, Florida
Harbourside Medical Tower
Tampa, Florida, United States, 33606
Sponsors and Collaborators
Kenneth Luberice
Investigators
Principal Investigator: Sarah M Cowgill, MD University of South Florida
More Information

Responsible Party: Kenneth Luberice, Clinical Research Coordinator, University of South Florida
ClinicalTrials.gov Identifier: NCT00519441     History of Changes
Other Study ID Numbers: 104802
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: August 15, 2012
Last Verified: August 2012

Keywords provided by Kenneth Luberice, University of South Florida:
laparoscopic Heller myotomy, achalasia, reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Achalasia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases