An observational study in Gastroesophageal Reflux Disease, sponsored by University of Pittsburgh. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by University of Pittsburgh · Observational
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 outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.
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 fundoplication (wrapping or gathering the stomach around the lower end of the esophagus to reduce or prevent reflux) are now available. Patient derived outcomes such as QOL and satisfaction are rarely taken into consideration when evaluating such new treatments. Outcome analysis of the results of medical and surgical treatments using an ongoing database of patients will enhance our ability to treat patients with GERD.
This study's goal is to build a database to collect the outcome information on patients who are having medical or surgical treatment of GERD. In addition we want to measure standard outcomes such as morbidity, mortality, medication use and patient derived outcomes such as general and disease specific QOL, and patient satisfaction with the treatment. We also want to assess if and how long QOL is improved by medical and surgical treatment methods. In addition we want to see if low QOL scores on medical treatment as well as the standard medical criteria can help to identify which patients may benefit from surgical (an operation) rather than the medical treatment. It is hoped that we can also identify which factors might predict or help to determine which patients will have failure of both medical and surgical treatments of GERD. Using this information we want to identify if a psychological profile done before treatment will influence or predict the outcomes of treatment.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's planned enrollment of 2,500 is above the median of 178 across 348 observational studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with a diagnosis of reflux seeking treatment in a physician's office.
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Patients with reflux symptoms present for at least 6 months, caused by documented reflux. Reflux symptoms include:
Exclusion Criteria:
Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.
Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.
Questionnaire administered postoperatively at set intervals.
Questionnaire administered preoperatively and at set intervals postoperatively.
Plan to share: Undecided
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The record gives a start of Apr 1999, a primary completion of Dec 2050 and a completion of Dec 2050. It does not say whether these dates are actual or estimated.
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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