Reflux Clinical Trial
Official title:
Gastroesophageal Reflux in Patients With Achalasia
Verified date | August 2012 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | June 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Harbourside Medical Tower | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Kenneth Luberice |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 years | No |
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