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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…
ClinicalTrials.gov, NCT07093359

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