Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

460

participants targeted

Target at P50-P75 for phase_3

Timeline

39mo left

Started Mar 2025

Typical duration for phase_3

Geographic Reach

1 country

5 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.3 years study duration

Study Progress27%

Mar 2025Jul 2029

Study Start

First participant enrolled

March 6, 2025

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed

28 days until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed

3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2029

Expected

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

August 5, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

July 2, 2025

Last Update Submit

August 4, 2025

Conditions

Gastro-oesophageal Reflux Disease

Keywords

LINXGORDGERDFundoplicationREFLUXANTI REFLUX

Outcome Measures

Primary Outcomes (1)

Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire
24 months following surgery

Secondary Outcomes (9)

Prevalence of gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire
24 months postoperatively
Prevalence of inability to belch measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire
24 months postoperatively
Prevalence of symptomatic GORD, inability to belch and gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire
6 weeks, 6 and 12 months after surgery
Severity of dysphagia and regurgitation measured using participant-reported outcomes/GORD-HRQL questionnaire
6 weeks, 6, 12 and 24 months postoperatively
Global HRQL measured using participant-reported outcomes/EQ-5D-5L questionnaire
6 weeks, 6, 12 and 24 months postoperatively
+4 more secondary outcomes

Study Arms (2)

Laparoscopic or robotic fundoplication

ACTIVE COMPARATOR

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.

Procedure: Laparoscopic or robotic fundoplication

Laparoscopic or robotic LINX procedure

EXPERIMENTAL

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 LINX procedure

Interventions

Laparoscopic or robotic LINX procedurePROCEDURE

Laparoscopic or robotic LINX procedure

Laparoscopic or robotic fundoplicationPROCEDURE

Laparoscopic or robotic fundoplication

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia
Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials
Previous anti-reflux or gastric surgery
Previous or planned neurosurgical intervention
Oesophageal manometry showing complete absence of lower oesophageal contractility

Contact the study team to confirm eligibility.