Gastro-oesophageal Reflux DiseasePhase 3GOLFNCT07093359
LINX vs Fundoplication
A Phase 3 study testing Laparoscopic or robotic LINX procedure and Laparoscopic or robotic fundoplication in people with Gastro-oesophageal Reflux Disease, run by University of Oxford at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastro-oesophageal Reflux Disease
- What is being tested?
- Laparoscopic or robotic LINX procedure and Laparoscopic or robotic fundoplication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 6 Mar 2025to Jul 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Recruiting
Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's Hospital
Oxford, Oxfordshire, OX3 7LD
James Gossage, 00000, james.gossage@nhs.net
- Recruiting
Imperial College Healthcare NHS Trust, St Mary's Hospital
Oxford, Oxfordshire, OX3 7LD
Ahmed Ahmed, 00000, ahmed.ahmed4@nhs.net
- Recruiting
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Oxford, Oxfordshire, OX3 7LD
Andy Cockbain, 00000, andy.cockbain@nhs.net
- Recruiting
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Oxford, Oxfordshire, OX3 7LD
Sheraz Markar, 00000, sheraz.markar@ouh.nhs.uk
- Recruiting
University Hospital Southampton NHS Foundation Trust
Oxford, Oxfordshire, OX3 7LD
Fergus Noble, 00000, fergus.noble@uhs.nhs.uk
About this study
Official title: Double-blind Randomised Controlled Trial for Treatment of Gastro-Oesophageal Reflux Disease; LINX Management System vs. Fundoplication (GOLF)
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
- Being tested
- Laparoscopic or robotic LINX procedure, Laparoscopic or robotic fundoplication
- Keywords
- LINX, GORD, GERD, Fundoplication, REFLUX, ANTI REFLUX
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic or robotic LINX procedureProcedure or surgery
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.
Laparoscopic or robotic fundoplicationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Laparoscopic or robotic LINX procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire
Measured: 24 months following surgery
Secondary outcomes (9)
Prevalence of gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire
Measured: 24 months postoperatively
Prevalence of inability to belch measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire
Measured: 24 months postoperatively
Prevalence of symptomatic GORD, inability to belch and gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire
Measured: 6 weeks, 6 and 12 months after surgery
Severity of dysphagia and regurgitation measured using participant-reported outcomes/GORD-HRQL questionnaire
Measured: 6 weeks, 6, 12 and 24 months postoperatively
Global HRQL measured using participant-reported outcomes/EQ-5D-5L questionnaire
Measured: 6 weeks, 6, 12 and 24 months postoperatively
Utilisation of anti-GORD medications measured using participant-reported outcomes/questionnaire
Measured: 6 weeks, 6, 12 and 24 months postoperatively
24-hour pH measurement measured using participant's medical records/24-hour pH measurement or BRAVO test
Measured: 12 months postoperatively
Postoperative complication rates, including reoperation and endoscopic reintervention, measured using participant's medical records/postoperative outcomes
Measured: 30-day, 90-day, 12 and 24-month
Cost-effectiveness of both treatments as measured by incremental cost per quality-adjusted life year (QALY)
Measured: 6 weeks, 6, 12 and 24 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start6 Mar 2025
- Primary completionFeb 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro-oesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, Imperial College London, Oxford University Hospitals NHS Trust, Guy's and St Thomas' NHS Foundation Trust, University of Bristol, University of Southampton
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093359
- Sponsor's protocol ID
- IRAS 331404
- Other IDs
- NIHR152268, ISRCTN 13533177
- Acronym
- GOLF
- Status last verified
- Jun 2025
- First submitted
- 2 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data-sharing plans for the current study are unknown and will be made available at a later date.