Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/23/2018 |
| Start Date: | April 1999 |
| End Date: | December 2050 |
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.
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.
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.
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 surgical management of GERD and/or hiatal hernia
- 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.
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: James D. Luketich, MD
Phone: 412-647-8583
Click here to add this to my saved trials
