Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

NCT ID: NCT00260572

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 2050-12-31

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.

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Questionnaires to evaluate QOL

Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.

Intervention Type: BEHAVIORAL

Questionnaires to evaluate heartburn and quality of life

Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.

Intervention Type: BEHAVIORAL

Questionnaire to evaluate satisfaction with treatment

Questionnaire administered postoperatively at set intervals.

Intervention Type: BEHAVIORAL

Questionnaire to evaluate presence or absence of pain

Questionnaire administered preoperatively and at set intervals postoperatively.

Intervention Type: BEHAVIORAL

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

James Luketich

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James D. Luketich, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiothoracic Surgery

Locations

UPMC Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY20050057

Identifier Type: -

Identifier Source: org_study_id