LINX vs Fundoplication

Summary

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 randomise 460 patients to receive fundoplication or the LINX device. It will be conducted across at least 16 UK and 7 European specialist surgical centres. All participants will be followed up at 6 weeks, 6, 12 and 24 months to assess which treatment offers the best results after surgery. A quality assurance programme within participating centres will ensure that procedures are completed to a high-quality standard. Study results will incorporate a patient and public involvement programme, which will inform national and international guidelines for the surgical treatment of reflux disease.

Conditions

• Gastro-oesophageal Reflux Disease

Interventions

PROCEDURE

Laparoscopic or robotic LINX procedure

Participants randomised to laparoscopic or robotic magnetic sphincter augmentation (LINX procedure) will receive surgical treatment under general anaesthesia, with placement of the LINX device around the distal oesophagus. The LINX device comprises titanium beads with magnets in the centre.

PROCEDURE

Laparoscopic or robotic fundoplication

Participants randomised to laparoscopic or robotic fundoplication will receive surgical treatment for managing GORD including a total or partial fundic wrap behind or in front of the distal oesophagus and gastro-oesophageal junction.

Sponsors & Collaborators

• King's College London

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Oxford University Hospitals NHS Trust

  collaborator OTHER

• Guy's and St Thomas' NHS Foundation Trust

  collaborator OTHER

• University of Bristol

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• University of Oxford

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-06

Primary Completion

2029-02-28

Completion

2029-07-31

Countries

• United Kingdom

Study Locations