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Gastroesophageal Reflux Disease Prospective Registry (GERD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02479438
Recruitment Status : Recruiting
First Posted : June 24, 2015
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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Brief 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.

Condition or disease Intervention/treatment
GERD 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Gastroesophageal Reflux Disease Prospective Registry
Study Start Date : January 2014
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : July 2030

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Groups and Cohorts
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Group/Cohort Intervention/treatment
Diagnosed with GERD
Collect data on GERD patients
 Other: Diagnosed with GERD
Recording of patient outcomes


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative patient reported sign and symptoms [ Time Frame: Up to 10 years after surgery ]
    Patient reported signs and symptoms as reported in Reflux scale and GERD questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of GERD or a similar disease of the stomach, esophagus or digestive tract.
Criteria

Inclusion Criteria:

- Any patient undergoing anti-reflux surgery

Exclusion Criteria:

- None

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479438


Contacts
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Contact: Christine Sanchez, MA 214-820-4589 christine.sanchez2@BSWHealth.org
Contact: Tammy Fisher, RN 214-820-7221 Tammy.Fisher@BSWHealth.org

Locations
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United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Contact: Estrellita Ontiveros, MA    214-820-5283    Estrellita.Ontiveros@BSWHealth.org   
Contact: Tammy Fisher, RN    214-820-7221    Tammy.Fisher@BSWHealth.org   
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Steven Leeds, MD Baylor Health Care System
More Information
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Additional Information:

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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT02479438    
Other Study ID Numbers: 014-008
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
 Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases