View Clinical Trial (Medical Research Study)
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
| City: |
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Pittsburgh |
| State: |
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Pennsylvania |
| Zip Code: |
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15213 |
| Conditions: |
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Gastroesophageal Reflux Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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Inclusion Criteria:
- 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 laparoscopic Nissen fundoplication or laparoscopic Toupet
fundoplication.
- Patients currently or commencing treatment with at least proton pump inhibitors or
pro-motility agents.
Exclusion Criteria:
- Patients unable to comprehend or complete the QOL instruments.
- Patients less than 18 years of age.
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| NCT ID: |
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NCT00260572 |
| Primary Contact: |
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Principal Investigator
James D. Luketich, MD
Department of Cardiothoracic Surgery
Julie A Ward, BSN
Phone: 412-647-8583
Email: wardj@upmc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Pittsburgh, Pennsylvania 15213
United States
Julie A. Ward, BSN
Phone: 412-647-8583
Email: wardj@upmc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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