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.

Study Overview

• Status: Active, not recruiting
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Department of Cardiothoracic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: James D. Luketich, MD, Department of Cardiothoracic Surgery

Study record dates

Study Major Dates

• Study Start: April 1, 1999
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050

Study Registration Dates

• First Submitted: November 28, 2005
• First Submitted That Met QC Criteria: November 28, 2005
• First Posted (Estimated): December 1, 2005

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: GERD; reflux; heartburn; dyspepsia; QOL; fundoplication; nissen; toupet; 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 (numeric scale used to specify the acidity of gastric contents); On or starting treatment with PPI or pro-motility agents
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic
• Other Study ID Numbers: STUDY20050057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No