Registry of Outcomes From AntiReflux Surgery

Completed

Conditions studied: Gastroesophageal Reflux Disease, Hiatal Hernia

In brief

Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.

Key facts

Study ID

NCT02923362

Run by

The Heartburn Foundation

People needed

1941

Starts

2016-05-01

Expected to finish

2023-05-03

Last updated by the study team

2026-08-07

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject must be at least 21years of age and at least the minimum Age of Majority according to applicable state law.
• Subject is a suitable surgical candidate, i.e. is able to undergo appropriate anesthesia and endoscopic procedure or laparoscopic surgery.
• Appropriate indications for and documentation of disease process requiring surgery. (Documented gastroesophageal reflux disease by accepted endoscopic or ambulatory reflux monitoring criteria, or have a hiatal hernia that meets accepted criteria for repair (e.g. large paraesophageal hernia with chest pain)).
• Subject is willing and able to cooperate with follow-up examinations
• Subject has been informed of the study procedures and treatment and has signed an informed consent for the study.

You may not qualify if…

• Suspected or confirmed esophageal or gastric cancer.
• Cannot understand trial requirements or is unable to comply with follow-up schedule
• Pregnant or nursing, or plans to become pregnant during the course of the study
• Medical illness (i.e. congestive heart failure) that may cause the subject to be non-compliant with or able to meet the protocol requirements or is associated with limited life expectancy (i.e. less than 3 years)
• Diagnosed psychiatric disorder (e.g. bipolar, schizophrenia, etc.), subjects that exhibit depression that are on appropriate medication(s) are allowable.

Where it is running

• Advanced Surgeons, PC — Birmingham, Alabama, United States
• University of Southern Alabama — Mobile, Alabama, United States
• The Arkansas Heartburn Treatment Center — Heber Springs, Arkansas, United States
• Bass Medical Group — Walnut Creek, California, United States
• HealthOne Cardiothoracic Surgery Associates — Aurora, Colorado, United States
• Institute of Esophageal and Reflux Surgery — Englewood, Colorado, United States
• Suncoast Surgical Associates — Brandon, Florida, United States
• South Florida Surgical Specialists, LLC — Coral Springs, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Tampa Bay Reflux Center — Riverview, Florida, United States
• The Tampa Bay Reflux Center — Tampa, Florida, United States
• Coastal Carolina Bariatric and Surgical Center — Summerville, South Carolina, United States
• Baylor Scott and White Research Institute — Dallas, Texas, United States
• Baylor University Medical Center at Dallas — Dallas, Texas, United States
• Houston Methodist Research Institute — Houston, Texas, United States
• North Texas Surgical Oncology Associates — Plano, Texas, United States
• Swedish Health Services — Seattle, Washington, United States
• Affinity Medical Group — Chilton, Wisconsin, United States
• Froedtert & The Medical College of Wisconsin Hospitals and Health Partners — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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