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| Tracking Information | |||||
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| First Received Date ICMJE | November 28, 2005 | ||||
| Last Updated Date | October 13, 2008 | ||||
| Start Date ICMJE | April 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00260572 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease | ||||
| Official Title ICMJE | Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease | ||||
| 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 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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| 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 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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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Prospective | ||||
| Condition ICMJE | Gastroesophageal Reflux Disease | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 1500 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00260572 | ||||
| Responsible Party | James Luketich, MD, University of Pittsburgh | ||||
| Study ID Numbers ICMJE | #99-0355 | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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