Registry of Outcomes From AntiReflux Surgery
ROARS
1 other identifier
observational
2,500
1 country
19
Brief Summary
Prospective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 3, 2016
CompletedFirst Posted
Study publicly available on registry
October 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2025
CompletedFebruary 21, 2023
February 1, 2023
6.8 years
October 3, 2016
February 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life reported by patient
Standard GERD Quality of Life Assessment
5 Years
Study Arms (2)
Laparoscopic Fundoplication Group
This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair.
LINX Antireflux Device Group
This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair.
Interventions
The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.
The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.
Eligibility Criteria
Male and female patient over the age of 21 with no maximum age who meet the eligibility for anti reflux and or hiatal hernia repair surgery
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Advanced Surgeons, PC
Birmingham, Alabama, 35243, United States
University of Southern Alabama
Mobile, Alabama, 36617, United States
The Arkansas Heartburn Treatment Center
Heber Springs, Arkansas, 72543, United States
Bass Medical Group
Walnut Creek, California, 94598, United States
HealthOne Cardiothoracic Surgery Associates
Aurora, Colorado, 80012, United States
Institute of Esophageal and Reflux Surgery
Englewood, Colorado, 80113, United States
Suncoast Surgical Associates
Brandon, Florida, 33511, United States
South Florida Surgical Specialists, LLC
Coral Springs, Florida, 33065, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Tampa Bay Reflux Center
Riverview, Florida, 33578, United States
The Tampa Bay Reflux Center
Tampa, Florida, 33609, United States
Coastal Carolina Bariatric and Surgical Center
Summerville, South Carolina, 29485, United States
Baylor Scott and White Research Institute
Dallas, Texas, 75204, United States
Baylor University Medical Center at Dallas
Dallas, Texas, 75246, United States
Houston Methodist Research Institute
Houston, Texas, 77030, United States
North Texas Surgical Oncology Associates
Plano, Texas, 75075, United States
Swedish Health Services
Seattle, Washington, 98103, United States
Affinity Medical Group
Chilton, Wisconsin, 53014, United States
Froedtert & The Medical College of Wisconsin Hospitals and Health Partners
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reginald Bell, MD
The Heartburn Foundation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2016
First Posted
October 4, 2016
Study Start
May 1, 2016
Primary Completion
March 1, 2023
Study Completion
May 1, 2025
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share