Outcomes After Medical and Surgical Treatment of Gastroesophageal Reflux Disease

NCT00260572 | Active Not Recruiting

• 1 other identifier: STUDY20050057
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD; nissen; fundoplication; reflux; toupet; QOL; dyspepsia; heartburn; 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

Interventions

Questionnaires to evaluate QOL BEHAVIORAL

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

Questionnaires to evaluate heartburn and quality of life BEHAVIORAL

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

Questionnaire to evaluate satisfaction with treatment BEHAVIORAL

Questionnaire administered postoperatively at set intervals.

Questionnaire to evaluate presence or absence of pain BEHAVIORAL

Questionnaire administered preoperatively and at set intervals postoperatively.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients unable to comprehend or complete the QOL instruments.
• Patients less than 18 years of age.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC Department of Cardiothoracic Surgery

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Dyspepsia; Heartburn

Interventions

Quality of Life; Therapeutics

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• James D. Luketich, MD

  Department of Cardiothoracic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: December 1, 2005
• Study Start: April 1, 1999
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

US (1)