Double-blind Randomised Controlled Trial for Treatment of Gastro-Oesophageal Reflux Disease; LINX Management System vs. Fundoplication (GOLF)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age 18 years and above

• Willing and able to give informed consent

• Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery

• Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflux oesophagitis, or 24-hour pH study or BRAVO test of the oesophagus consistent with GORD

• No hiatal hernia or hiatal hernia \<5 cm in length

• Adequate lower oesophageal motility as defined by preoperative oesophageal manometry study. Oesophageal manometry will show a mean contractile amplitude of \>30 mmHg or DCI \>450 mmHg-s-cm in 70% of swallows.

Locations
Other Locations
United Kingdom
Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's Hospital
RECRUITING
Oxford
Imperial College Healthcare NHS Trust, St Mary's Hospital
RECRUITING
Oxford
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
RECRUITING
Oxford
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
RECRUITING
Oxford
University Hospital Southampton NHS Foundation Trust
RECRUITING
Oxford
Contact Information
Primary
Sheraz Markar, PhD, FRCS, MSc, MA
golf@nds.ox.ac.uk
+44 07584039433
Time Frame
Start Date: 2025-03-06
Estimated Completion Date: 2029-07
Participants
Target number of participants: 460
Treatments
Active_comparator: 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.
Experimental: 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.
Sponsors
Leads: University of Oxford
Collaborators: Imperial College London, Guy's and St Thomas' NHS Foundation Trust, University of Bristol, King's College London, University of Southampton, Oxford University Hospitals NHS Trust

This content was sourced from clinicaltrials.gov