Observational Study of Anti-Reflux Surgery

Torax Medical

Status: Completed

Conditions: Gastro Esophageal Reflux; Gastroesophageal Reflux; GERD

Study type: Observational

Funder types: Industry

Identifiers

NCT01624506

2776

Details and patient eligibility

About

The Anti-Reflux Surgical Study has been established to:

• Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
• Track the clinical course of patients from pre-operative assessment to three years post-surgery

Full description

This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

Enrollment: 760 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals treated with LINX Reflux Management System or Fundoplication
• Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
• Individuals willing to complete questionnaires and comply with the three years of follow-up.

Exclusion criteria

• Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy <3 years)

Trial design

760 participants in 2 patient groups

Magnetic Sphincter Augmentation

Description:

Patients will be treated with magnetic sphincter augmentation via the LINX Reflux Management System

Fundoplication

Description:

Patients treated with laparoscopic fundoplication