Transoral Incisionless Fundoplication Database Repository (TIF)
- Conditions
- Gastroesophageal Reflux Disease
- Registration Number
- NCT04306380
- Lead Sponsor
- Indiana University
- Brief Summary
Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.
- Detailed Description
Collect patient information related to transoral incisionless fundoplication (TIF) done for gastroesophageal reflux disease. The database information with be used for research to assess trends improve patient care.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- Having a TIF procedure completed at Indiana University Health, University Hospital
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Exclusion Criteria
- under 13 years of age
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GERD-Health Related Quality of Life Questionnaire (GERD_HRQL) baseline; 6,12,24 and 60 months Change in score for questionnaire related to quality of life with GERD
RESQ-7 questionnaire baseline; 6,12,24 & 60 months Change in score for questionnaire related to symptoms of GERD
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States