Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00260572|
Recruitment Status : Active, not recruiting
First Posted : December 1, 2005
Last Update Posted : August 21, 2018
|Condition or disease||Intervention/treatment|
|Gastroesophageal Reflux Disease||Behavioral: Questionnaires to evaluate QOL Behavioral: Questionnaires to evaluate heartburn and quality of life Behavioral: Questionnaire to evaluate satisfaction with treatment Behavioral: Questionnaire to evaluate presence or absence of pain|
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.
|Study Type :||Observational|
|Estimated Enrollment :||2500 participants|
|Official Title:||Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease|
|Study Start Date :||April 1999|
|Estimated Primary Completion Date :||December 2050|
|Estimated Study Completion Date :||December 2050|
- Behavioral: Questionnaires to evaluate QOL
Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.
- Behavioral: Questionnaires to evaluate heartburn and quality of life
Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.
- Behavioral: Questionnaire to evaluate satisfaction with treatment
Questionnaire administered postoperatively at set intervals.
- Behavioral: Questionnaire to evaluate presence or absence of pain
Questionnaire administered preoperatively and at set intervals postoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00260572
|United States, Pennsylvania|
|UPMC Department of Cardiothoracic Surgery|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||James D. Luketich, MD||Department of Cardiothoracic Surgery|