Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00260572
• Other study ID #: STUDY20050057
• Status: Active, not recruiting
• Start date: April 1999
• Est. completion date: December 2050

Study information

• Verified date: February 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: December 2050
• Est. primary completion date: December 2050
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Behavioral:
• Questionnaires to evaluate QOL
Questionnaire to evaluate QOL administered preoperatively and postoperatively at set intervals.
• Questionnaires to evaluate heartburn and quality of life
Questionnaires to evaluate heartburn and quality of life administered preoperatively and at set intervals postoperatively.
• Questionnaire to evaluate satisfaction with treatment
Questionnaire administered postoperatively at set intervals.
• Questionnaire to evaluate presence or absence of pain
Questionnaire administered preoperatively and at set intervals postoperatively.

Locations

Country	Name	City	State
United States	UPMC Department of Cardiothoracic Surgery	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States,