Registry of Outcomes From AntiReflux Surgery

Active, not recruiting

• Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease

• Registration Number: NCT02923362
• Lead Sponsor: The Heartburn Foundation

Brief Summary

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

Detailed Description

This is a prospective, multi center, observational database of patients that are having surgical laparoscopic antireflux procedure and/or hiatal hernia repair, including laparoscopic Nissen fundoplication and Magnetic Sphincter Augmentation with the LINX device. Patients meeting registry inclusion and exclusion will be followed for 5 years with standardized quality of life surveys and appropriate standard of care testing. Up to 40 sites will participate with total enrollment of 1000 patients.

The main objectives are to collect data from everyday clinical practices and track patients from preoperative assessments to 5 years post surgical intervention to evaluate symptoms, medication use and side effects.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-10-03
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-16
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of Life reported by patient	5 Years	Standard GERD Quality of Life Assessment

Trial Locations

Locations (19)

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

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