Registry of Outcomes From AntiReflux Surgery (ROARS)

Registry of Outcomes From AntiReflux Surgery (ROARS)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease
• Intervention / Treatment: Procedure: Laparoscopic Fundoplication; Device: LINX Antireflux

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Advanced Surgeons, PC
    • Mobile, Alabama, United States, 36617
      • University of Southern Alabama
  • Arkansas
    • Heber Springs, Arkansas, United States, 72543
      • The Arkansas Heartburn Treatment Center
  • California
    • Walnut Creek, California, United States, 94598
      • Bass Medical Group
  • Colorado
    • Aurora, Colorado, United States, 80012
      • HealthOne Cardiothoracic Surgery Associates
    • Englewood, Colorado, United States, 80113
      • Institute of Esophageal and Reflux Surgery
  • Florida
    • Brandon, Florida, United States, 33511
      • Suncoast Surgical Associates
    • Coral Springs, Florida, United States, 33065
      • South Florida Surgical Specialists, LLC
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic
    • Riverview, Florida, United States, 33578
      • Tampa Bay Reflux Center
    • Tampa, Florida, United States, 33609
      • The Tampa Bay Reflux Center
  • South Carolina
    • Summerville, South Carolina, United States, 29485
      • Coastal Carolina Bariatric and Surgical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center at Dallas
    • Dallas, Texas, United States, 75204
      • Baylor Scott and White Research Institute
    • Houston, Texas, United States, 77030
      • Houston Methodist Research Institute
    • Plano, Texas, United States, 75075
      • North Texas Surgical Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98103
      • Swedish Health Services
  • Wisconsin
    • Chilton, Wisconsin, United States, 53014
      • Affinity Medical Group
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert & The Medical College of Wisconsin Hospitals and Health Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.; Other Names: Nissen Fundoplication; Fundoplication; Fundoplasty; Hiatal Hernia Repair; Partial Fundoplication
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.	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.; Other Names: LINX Reflux Management System; LINX System; LINX Implant; LINX Magnetic Sphincter Augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life reported by patient	Standard GERD Quality of Life Assessment	5 Years

Collaborators and Investigators

• Sponsor: The Heartburn Foundation
• Investigators: Principal Investigator: Reginald Bell, MD, The Heartburn Foundation

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: October 3, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: GERD; LINX; Magnetic Sphincter Augmentation; Reflux; Laryngopharyngeal Reflux; Heartburn; Regurgitation; Acid Reflux; Hiatal Hernia; LPR; Nissen; Antireflux Surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Hernia, Diaphragmatic; Internal Hernia; Hernia; Gastroesophageal Reflux; Hernia, Hiatal
• Other Study ID Numbers: THF001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO