Status:
ACTIVE_NOT_RECRUITING
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
Lead Sponsor:
University of Pittsburgh
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Brief Summary
The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcome...
Detailed Description
GERD is a significant public health problem and when it is severe it may have a considerable impact on patients' QOL. Relatively new treatments such as proton pump inhibitors (PPI) and laparoscopic fu...
Eligibility Criteria
Inclusion
- Patients with reflux symptoms present for at least 6 months, caused by documented reflux. Reflux symptoms include:
- heartburn
- acid regurgitation
- waterbrash
- non-cardiac chest pain
- dyspepsia
- Reflux diagnosis either by endoscopy, upper gastrointestinal (GI), or 24 hour pH.
- Patients scheduled for surgical management of GERD and/or hiatal hernia
- Patients currently or commencing treatment with at least proton pump inhibitors or pro-motility agents.
Exclusion
- Patients unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
Key Trial Info
Start Date :
April 1 1999
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2050
Estimated Enrollment :
2500 Patients enrolled
Trial Details
Trial ID
NCT00260572
Start Date
April 1 1999
End Date
December 1 2050
Last Update
April 16 2025
Active Locations (1)
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1
UPMC Department of Cardiothoracic Surgery
Pittsburgh, Pennsylvania, United States, 15213