Achalasia Clinical Trial
Official title:
Achalasia Patient Reported Outcomes
NCT number | NCT02606578 |
Other study ID # | 15-006921 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | January 15, 2021 |
Verified date | March 2024 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other.
Status | Terminated |
Enrollment | 200 |
Est. completion date | January 15, 2021 |
Est. primary completion date | January 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: - >18 years old - Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures - Esophagus diameter less <8 cm on barium swallow test Exclusion Criteria: - Pregnant - Diverticular disease of the esophagus - Barrett's esophagus - Extensive abdominal adhesions - <50% predicted FEV1 on pulmonary function testing - Cardiac ejection fraction <25% - Esophageal stricture from prior myotomy - Sigmoidization of the esophagus - More than one prior balloon dilation (>3 cm) or any prior dilation of 3 cm |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire | Comparison of surgical techniques evaluated from the patient's medical record using patient reported post-operative symptoms on the achalasia questionnaire. The achalasia questionnaire includes quality of life, pain, activity level, heart burn, acid regurgitation, reflux, dysphagia, and diet. | 2 years |
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