Looking for volunteers
LINX vs Fundoplication
NCT07093359 · University of Oxford · Updated 5 Aug 2025
- What is being tested
- Laparoscopic or robotic LINX procedure; Laparoscopic or robotic fundoplication
- For
- Gastro-oesophageal Reflux Disease
- Kind of study
- Tests a treatment or device on volunteers. Phase 3.
- Who can join
- Ages 18 years and older. About 460 people. The full rules are on the registry page.
- Where
- United Kingdom (5 sites)
- When
- Starts or started 6 March 2025, ends July 2029. Registered 30 July 2025.
- Results
- None posted yet.
In the researchers' words
Reflux disease can severely impact upon quality-of-life and lead to complications, including ulceration of the oesophagus. It is often controlled with self-help measures and medication. However, sometimes surgery is recommended. The current standard surgical treatment is called a fundoplication. This operation is carried out through keyhole (laparoscopic) surgery, and tightens the lower oesophagus to prevent reflux. Fundoplication is very safe and improves the quality-of-life of most patients. However, many patients have gas bloating, difficulty swallowing and recurrence of their reflux symptoms. As an alternative, some surgeons use a device called LINX, using a keyhole procedure. LINX is a magnetic device that wraps around the lower oesophagus to prevent reflux. Studies suggest that LINX may cause fewer complications, with a similar improvement in quality-of-life. However, there is a need for better evidence to compare LINX with fundoplication in the surgical treatment of reflux disease. GOLF is a multi-centre study designed which to determine if LINX achieves similar reflux control and improves symptoms compared to fundoplication. GOLF measures: (1) quality of life,(2) surgical complications, including need for additional treatment, (3) financial cost-effectiveness and (4) objectively measure the presence of acid that has refluxed into the lower oesophagus. GOLF aims…
Sites
- Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's HospitalOxford, Oxfordshire, United Kingdom
- Imperial College Healthcare NHS Trust, St Mary's HospitalOxford, Oxfordshire, United Kingdom
- Leeds Teaching Hospitals NHS Trust, St James's University HospitalOxford, Oxfordshire, United Kingdom
- Oxford University Hospitals NHS Foundation Trust, Churchill HospitalOxford, Oxfordshire, United Kingdom
- University Hospital Southampton NHS Foundation TrustOxford, Oxfordshire, United Kingdom
