Back to resultsDo Patients Who Have Had Surgery for Achalasia Suffer From Reflux
Primary Purpose
Reflux
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pH study
Sponsored by
About this trial
This is an interventional diagnostic trial for Reflux focused on measuring laparoscopic Heller myotomy, achalasia, reflux
Eligibility 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
Sites / Locations
- Harbourside Medical Tower
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
I
Arm Description
All patients in the study will have pH studies done in order to determine the degree of reflux after laparoscopic Heller myotomies.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00519441
Brief Title
Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux
Official Title
Gastroesophageal Reflux in Patients With Achalasia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Luberice
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflux
Keywords
laparoscopic Heller myotomy, achalasia, reflux
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Other
Arm Description
All patients in the study will have pH studies done in order to determine the degree of reflux after laparoscopic Heller myotomies.
Intervention Type
Other
Intervention Name(s)
pH study
Other Intervention Name(s)
Bravo
Intervention Description
All patients will have 48 hour pH study
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah M Cowgill, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harbourside Medical Tower
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Do Patients Who Have Had Surgery for Achalasia Suffer From Reflux
We'll reach out to this number within 24 hrs