Registry of Outcomes From AntiReflux Surgery

Gastroesophageal Reflux Disease Clinical Trial

— ROARS  

Official title:

Registry of Outcomes From AntiReflux Surgery (ROARS)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02923362
• Other study ID #: THF001
• Status: Active, not recruiting
• Start date: May 2016
• Est. completion date: May 2025

Study information

• Verified date: February 2023
• Source: The Heartburn Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2500
• Est. completion date: May 2025
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Hernia
• Hernia, Hiatal
• Hiatal Hernia

Intervention

Procedure:
• Laparoscopic Fundoplication
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.

Device:
• LINX Antireflux
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
The Heartburn Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Life reported by patient	Standard GERD Quality of Life Assessment	5 Years