Does the LINX procedure achieve similar reflux control and improve postoperative symptoms, specifically gas bloating and inability to belch, when compared to laparoscopic fundoplication?
| ISRCTN | ISRCTN13533177 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13533177 |
| ClinicalTrials.gov (NCT) | NCT07093359 |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 331404 |
| Protocol serial number | CPMS 58022, IRAS 331404 |
| Sponsor | University of Oxford |
| Funder | NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR152268 |
- Submission date
- 28/05/2024
- Registration date
- 03/06/2024
- Last edited
- 14/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Reflux disease, where stomach acid leaks up into the oesophagus (food pipe), can severely impact 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 and 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.
Who can participate?
Patients aged 18 years and above with gastro-oesophageal reflux disease that is insufficiently controlled by medical treatment or intolerance to medical treatment being considered for anti-reflux surgery
What does the study involve?
Patients will be randomly allocated to undergo either a laparoscopic LINX procedure or fundoplication. All participants will be followed up at 6 weeks, 6, 12 and 24 months to assess which treatment offers the best results after surgery. Quality of life, surgical complications, including the need for additional treatment, financial cost-effectiveness and the presence of acid that has refluxed into the lower oesophagus are all measured. 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.
What are the possible benefits and risks of participating?
The information from this study will help us understand whether the LINX procedure gives similar reflux control and improves symptoms after the operation, particularly gas bloating and not being able to burp, when compared to fundoplication at 24 months after surgery. At the moment this remains an unanswered question and this is why the researchers are doing this study.
Both fundoplication and the LINX procedure are well tolerated, but it is uncertain how common the side effects are with LINX compared to fundoplication - they could be similar, worse, or better; hence the need for this study to compare and find out. Both operations can result in gas bloating, difficulty belching and swallowing or an eventual recurrence of reflux symptoms after surgery and the need for reintervention or reoperation.
Where is the study run from?
University of Oxford (UK)
When is the study starting and how long is it expected to run for?
July 2023 to June 2028
Who is funding the study?
NIHR Efficacy and Mechanism Evaluation (EME) Programme (UK)
Who is the main contact?
GOLF Trial Manager, golf@nds.ox.ac.uk
Contact information
Principal investigator
Surgical Intervention Trials Unit (SITU)
University of Oxford
Botnar Research Centre
Nuffield Orthopaedic Centre
Old Road
Headington
Oxford
OX3 7LD
United Kingdom
 ORCID ID |
0000-0001-8650-2017 |
|---|---|
| Phone | +44 (0)7584 039433 |
| sheraz.markar@nds.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional; Design type: Treatment, Device, Surgery; Randomized |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Double-blind randomised controlled trial for treatment of Gastro-Oesophageal reflux disease; LINX management system vs Fundoplication (GOLF) |
| Study acronym | GOLF |
| Study objectives | This study aims to determine whether the LINX procedure achieves similar reflux control and improves postoperative symptoms, specifically gas bloating and inability to belch when compared to fundoplication at 24 months after surgery. |
| Ethics approval(s) | Approved 21/05/2024, Wales REC6 (Floor 4, Institute of Life Science 2, Swansea University, Swansea, SA2 8PP, UK; Wales.REC6@wales.nhs.uk), ref: 24/WA/0154 |
| Health condition(s) or problem(s) studied | Gastro-oesophageal reflux disease |
| Intervention | The GOLF study is a multi-centre, pragmatic, two-arm, double-blind, Phase III, randomized controlled trial (RCT). An embedded QuinteT Recruitment Intervention will be used to understand, monitor and address barriers to participation. The study will recruit 460 patients (230 in each of two arms) recommended for anti-reflux surgery with gastro-oesophageal reflux disease (GORD) from at least 16 UK and 7 non-UK European large upper gastro-intestinal surgical centres. Patients will be randomized 1:1 to receive either a laparoscopic LINX procedure or fundoplication. The primary outcome is the assessment of symptomatic GORD using the GORD-HRQL questionnaire at 24 months following surgery, and core secondary outcomes are the prevalence of inability to belch and gas bloating at 24 months also assessed by GORD-HRQL. Patients will be followed up either in clinic, via telephone or electronically at baseline, 6 weeks, 6, 12 and 24 months after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Symptomatic GORD and health-related quality of life (HRQL) assessed using the GORD-HRQL questionnaire at 24 months following surgery |
| Key secondary outcome measure(s) |
1. Prevalence of gas bloating measured using participant-reported outcomes/GORD-HRQL and Foregut Symptom Questionnaire at 24 months postoperatively |
| Completion date | 30/06/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 460 |
| Key inclusion criteria | 1. Age 18 years and above 2. Willing and able to give informed consent 3. Patients with GORD insufficiently controlled by medical therapy or intolerance to medical therapy being considered for anti-reflux surgery 4. 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 5. No hiatal hernia or hiatal hernia <5 cm in length 6. 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. |
| Key exclusion criteria | 1. Unsuitable for surgical intervention due to medical conditions precluding general anaesthesia 2. Suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials 3. Previous anti-reflux or gastric surgery 4. Previous or planned neurosurgical intervention 5. Oesophageal manometry showing complete absence of lower oesophageal contractility |
| Date of first enrolment | 30/06/2024 |
| Date of final enrolment | 30/06/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Oxford Road
Manchester
M13 9WL
England
Westbury-on-trym
Bristol
BS10 5NB
England
Cosham
Portsmouth
PO6 3LY
England
Marton Road
Middlesbrough
TS4 3BW
England
London
N19 5NF
England
Gloucester
GL1 3NN
England
Bordesley Green
Birmingham
B9 5ST
England
Floyd Drive
Warrington
WA2 8DB
England
Tremona Road
Southampton
SO16 6YD
England
Barnstaple
EX31 4JB
England
Westminster Bridge Road
London
SE1 7EH
England
Dartford
DA2 8DA
England
Derby
DE22 3NE
England
Warwick
CV34 5BW
England
Old Road
Headington
Oxford
OX3 7LE
England
Barrack Road
Exeter
EX2 5DW
England
Newton Road
Torquay
TQ2 7AA
England
Wrythe Lane
Carshalton
SM5 1AA
England
Derby Road
Nottingham
NG7 2UH
England
Croydon
CR7 7YE
England
Dudley
DY1 2HQ
England
Middlesbrough
TS4 3BW
England
Wexham
Slough
SL2 4HL
England
Frimley
Camberley
GU16 7UJ
England
London
SE1 9RT
England
Pield Heath Road
Uxbridge
UB8 3NN
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 12/07/2025 | 09/09/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/11/2025: Study participating centres updated.
09/09/2025: Publication reference, ClinicalTrials.gov number and study website added.
05/06/2025: Wexham Park Hospital, Frimley Park Hospital and Guy's Hospital were added to the study participating centres.
22/05/2025: Contact details updated.
28/05/2024: Study's existence confirmed by the NIHR.
