Gastroesophageal Reflux Disease Prospective Registry

GERD Clinical Trial

— GERD  

Official title:

Gastroesophageal Reflux Disease Prospective Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02479438
• Other study ID #: 014-008
• Status: Recruiting
• Start date: January 2014
• Est. completion date: July 2030

Study information

• Verified date: June 2020
• Source: Baylor Research Institute
• Contact: Christine Sanchez, MA
• Phone: 214-820-4589
• Email: christine.sanchez2[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient undergoing anti-reflux surgery

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• GERD

Intervention

Other:
• Diagnosed with GERD
Recording of patient outcomes

Locations

Country	Name	City	State
United States	Baylor Research Institute	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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