Registry of Outcomes From AntiReflux Surgery (ROARS)

The Heartburn Foundation

Status: Active, not recruiting

Conditions: Hiatal Hernia; Gastroesophageal Reflux Disease

Treatments: Device: LINX Antireflux; Procedure: Laparoscopic Fundoplication

Study type: Observational

Funder types: Other

Identifiers

NCT02923362

THF001

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,500 participants in 2 patient groups

Laparoscopic Fundoplication Group

Description:

This group of patients are surgical candidates based on preoperative testing results for laparoscopic fundoplication antireflux procedure and possible hiatal hernia repair.

Treatment:

Procedure: Laparoscopic Fundoplication

LINX Antireflux Device Group

Description:

This group of patients are surgical candidates based on preoperative testing results for the laparoscopic LINX antireflux device placement and possible hiatal hernia repair.

Treatment:

Device: LINX Antireflux