Gastroesophageal Reflux Disease Prospective Registry (GERD)

The purpose of this registry is to evaluate information to determine which operations and treatments for gastroesophageal reflux disease or similar diseases of the stomach, esophagus or digestive tract are providing the most benefit including the long-term effects of treatment (or no treatment) and the progression of the disease over time.

Study Overview

• Status: Recruiting
• Conditions: GERD
• Intervention / Treatment: Other: Diagnosed with GERD

Detailed Description

All patients in this registry will have a diagnosis of gastroesophageal reflux disease or a similar disease of the stomach, esophagus or digestive tract. Each patient undergoing anti-reflux surgery will be asked to participate in the registry to gather preoperative, intraoperative and postoperative outcomes. The data collected from the registry will be used to assess the outcome of various treatments, both standard and new: some specific areas of interest include the long-term effects of treatment (or no treatment), the progression of the disease over time, and the overall length of survival of the patient.

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Christine Sanchez, MA; Phone Number: 214-820-4589; Email: christine.sanchez2@BSWHealth.org
• Study Contact Backup: Name: Tammy Fisher, RN; Phone Number: 214-820-7221; Email: Tammy.Fisher@BSWHealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor Research Institute
      • Contact: Tammy Fisher, RN; Phone Number: 214-820-7221; Email: Tammy.Fisher@BSWHealth.org
      • Contact: Estrellita Ontiveros, MA; Phone Number: 214-820-5283; Email: Estrellita.Ontiveros@BSWHealth.org

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients with diagnosis of GERD or a similar disease of the stomach, esophagus or digestive tract.

Description

Inclusion Criteria:

- Any patient undergoing anti-reflux surgery

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnosed with GERD; Collect data on GERD patients	Other: Diagnosed with GERD; Recording of patient outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative patient reported sign and symptoms	Patient reported signs and symptoms as reported in Reflux scale and GERD questionnaire.	Up to 10 years after surgery

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Steven Leeds, MD, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2030
• Study Completion (Anticipated): July 1, 2030

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): June 29, 2020
• Last Update Submitted That Met QC Criteria: June 26, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 014-008