Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00260572
First received: November 28, 2005
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Estimated Enrollment: 1500
Study Start Date: April 1999
Estimated Study Completion Date: December 2050
Estimated Primary Completion Date: December 2050 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of reflux seeking treatment in a physician's office.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260572

Contacts
Contact: Julie A Ward, BSN 412-647-8583 wardj@upmc.edu

Locations
United States, Pennsylvania
UPMC Department of Cardiothoracic Surgery Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Julie A. Ward, BSN    412-647-8583    wardj@upmc.edu   
Principal Investigator: James D. Luketich, MD         
Sub-Investigator: Rodney J. Landreneau, MD         
Sub-Investigator: Kevin McGrath, MD         
Sub-Investigator: Arnold Wald, MD         
Sub-Investigator: Arjun Pennathur, MD         
Sub-Investigator: Neil A. Christie, MD         
Sub-Investigator: Matthew Schuchert, MD         
Sub-Investigator: John McClay Close, MA         
Sub-Investigator: Ghulam Abbas, MD         
Sub-Investigator: Manisha Shende, MD         
Sub-Investigator: Katie Nason, MD         
Sub-Investigator: Lawrence Crist, MD         
Sub-Investigator: Jason Lamb, MD         
Sub-Investigator: Omar Awais, MD         
Sub-Investigator: Samuel Keeley, MD         
Sub-Investigator: Angela Gallagher, CRNP         
Sub-Investigator: Benny Weksler, MD         
Sub-Investigator: Ryan Levy, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: James D. Luketich, MD Department of Cardiothoracic Surgery
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00260572     History of Changes
Other Study ID Numbers: #99-0355
Study First Received: November 28, 2005
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
heartburn
GERD
nissen
fundoplication
reflux
toupet
QOL
dyspepsia
Patients with reflux symptoms for at least 6 months
Patients scheduled for lap nissen or toupet fundoplication
Reflux diagnosed by either endoscopy, upper GI, or 24hr. pH
On or starting treatment with PPI or pro-motility agents

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014