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Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
This study is currently recruiting participants.
Study NCT00260572   Information provided by University of Pittsburgh
First Received: November 28, 2005   Last Updated: October 13, 2008   History of Changes

November 28, 2005
October 13, 2008
April 1999
 
 
 
Complete list of historical versions of study NCT00260572 on ClinicalTrials.gov Archive Site
 
 
 
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease
Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

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.

 
Observational
Case-Only, Prospective
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
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1500
 
 

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.
Both
18 Years and older
No
Contact: Julie A Ward, BSN 412-647-8583 wardj@upmc.edu
United States
 
NCT00260572
James Luketich, MD, University of Pittsburgh
#99-0355
University of Pittsburgh
 
Principal Investigator: James D. Luketich, MD Heart, Lung, and Esophageal Surgery Institute
University of Pittsburgh
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP