Clinical trial NCT02923362: Registry of Outcomes From AntiReflux Surgery
Official title: Registry of Outcomes From AntiReflux Surgery (ROARS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastroesophageal Reflux Disease
Hiatal Hernia
Keywords: GERD
Reflux
Acid Reflux
Heartburn
Regurgitation
Laryngopharyngeal Reflux
Hiatal Hernia
LPR
LINX
Magnetic Sphincter Augmentation
Antireflux Surgery
Nissen
Lead sponsor: The Heartburn Foundation
Sponsor class: OTHER
First posted: 2016-10-04
Enrollment: 2500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of Life reported by patient
timeFrame: 5 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Advanced Surgeons, PC
state: Alabama
city: Mobile
country: United States
facility: University of Southern Alabama
state: Alabama
city: Heber Springs
country: United States
facility: The Arkansas Heartburn Treatment Center
state: Arkansas
city: Walnut Creek
country: United States
facility: Bass Medical Group
state: California
city: Aurora
country: United States
facility: HealthOne Cardiothoracic Surgery Associates
state: Colorado
city: Englewood
country: United States
facility: Institute of Esophageal and Reflux Surgery
state: Colorado
city: Brandon
country: United States
facility: Suncoast Surgical Associates
state: Florida
city: Coral Springs
country: United States
facility: South Florida Surgical Specialists, LLC
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Riverview
country: United States
facility: Tampa Bay Reflux Center
state: Florida
city: Tampa
country: United States
facility: The Tampa Bay Reflux Center
state: Florida
city: Summerville
country: United States
facility: Coastal Carolina Bariatric and Surgical Center
state: South Carolina
city: Dallas
country: United States
facility: Baylor Scott and White Research Institute
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Research Institute
state: Texas
city: Plano
country: United States
facility: North Texas Surgical Oncology Associates
state: Texas
city: Seattle
country: United States
facility: Swedish Health Services
state: Washington
city: Chilton
country: United States
facility: Affinity Medical Group
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert & The Medical College of Wisconsin Hospitals and Health Partners
state: Wisconsin
Study officials:
affiliation: The Heartburn Foundation
name: Reginald Bell, MD
role: PRINCIPAL_INVESTIGATOR
References: