Does the LINX procedure achieve similar reflux control and improve postoperative symptoms, specifically gas bloating and inability to belch, when compared to laparoscopic fundoplication?
Gastro-oesophageal reflux disease (GORD) happens when stomach acid travels up into the food pipe, causing painful heartburn and tissue damage. When medicines do not help, surgery is often considered. The usual keyhole operation, called fundoplication, wraps part of the stomach around the food pipe to tighten it. While effective, it can cause long-term side effects like uncomfortable gas bloating and difficulty burping. An alternative keyhole option uses a small magnetic device called LINX, which wraps around the lower food pipe to keep it closed against acid. This trial, led by the University of Oxford, randomly places patients into two groups to receive either standard fundoplication or the LINX implant. Researchers will track patients for two years to compare symptom control, side effects, and overall quality of life. The results will help shape future NHS treatment guidelines for reflux surgery.
At a glance
What is this study about?
Acid reflux, or GORD, is a common condition where stomach acid splashes back up into the oesophagus (the food pipe). For many people, this causes painful heartburn, chest discomfort, or difficulty swallowing. When lifestyle changes and daily acid-lowering medicines fail to work well, or cause unpleasant side effects, doctors may suggest surgery to strengthen the natural valve between the stomach and food pipe.
The current standard operation is called fundoplication. Carried out through keyhole surgery, a surgeon wraps the upper part of the stomach around the bottom of the food pipe to create a tighter valve. Although this operation successfully controls acid for most people, it can leave patients with lasting side effects. Many find they can no longer burp normally, leading to trapped wind, painful stomach bloating, or trouble swallowing.
To address these problems, surgeons have developed a newer treatment called the LINX system. This involves placing a small, flexible ring of magnetic beads around the lower food pipe using keyhole surgery. The magnets hold the valve shut to block acid, but open naturally when you swallow food or need to burp.
The GOLF study aims to discover which of these two procedures provides the best balance of reflux control and day-to-day comfort. By comparing both treatments over two years, the study will provide clear, reliable evidence to help NHS surgeons and future patients choose the safest, most effective operation.
Key takeaways
- Compares two keyhole operations for severe acid reflux: the LINX magnetic ring and standard fundoplication.
- Aims to discover which procedure causes less bloating and difficulty burping.
- Open to adults aged 18 and over whose reflux is not controlled by medication.
- Participants are followed up closely for two years after surgery.
- Led by the University of Oxford and funded by the NHS research body (NIHR).
Who may be eligible?
You may be able to join this study if you are 18 or older and have severe acid reflux (GORD) that is not well managed by medicines, or if you cannot tolerate reflux medications. Your reflux must be confirmed through routine hospital tests, such as an endoscopy (a small camera looking down your food pipe) or a 24-hour acid level test. You will also need to have good muscle movement in your food pipe and no large hiatus hernia.
You will not be eligible if you have already had surgery on your stomach or food pipe, or if you have medical conditions that make general anaesthetics unsafe. Because the LINX device contains metal magnets, people with known metal allergies (such as nickel or titanium) or those who have had or need brain or nerve surgery cannot take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am 18 years of age or older.
- I have severe acid reflux (GORD) that medication does not properly control.
- I am being considered for keyhole anti-reflux surgery.
- I have never had previous surgery on my stomach or food pipe.
- I do not have allergies to metals like nickel, titanium, or stainless steel.
What does participation involve?
Taking part in the GOLF study lasts for around two years in total. If you take part, a computer will randomly assign you to have either standard fundoplication surgery or the LINX magnetic ring procedure. Both are performed as keyhole operations under general anaesthetic, meaning you will be asleep throughout. Neither you nor your research team can choose which operation you receive.
After your operation, the research team will check on your recovery at regular intervals: 6 weeks, 6 months, 12 months, and 24 months. During these follow-up checks, you will answer questions about your symptoms, your general quality of life, and whether you experience bloating or swallowing difficulties. You may also have follow-up tests to measure acid levels in your food pipe so doctors can see how well your operation is working.
Potential risks and benefits
Locations (26)
- Manchester Royal InfirmaryApproximateManchester, England
- Southmead HospitalApproximateBristol, England
- Queen Alexandra HospitalApproximatePortsmouth, England
- James Cook University HospitalApproximateMiddlesbrough, England
- The Whittington HospitalApproximateLondon, England
- Gloucestershire Royal HospitalUnverifiedGloucester, England
- Heartlands HospitalUnverifiedBirmingham, England
- St Marys HospitalUnverifiedWarrington, England
- Southampton General HospitalUnverifiedSouthampton, England
- North Devon District HospitalUnverifiedBarnstaple, England
- St Thomas' HospitalUnverifiedLondon, England
- Darent Valley HospitalUnverifiedDartford, England
Common questions
How is my treatment decided?
A computer randomly allocates you to receive either the LINX device or standard fundoplication surgery. This gives an equal chance of receiving either operation.
What is the main difference between the two operations?
Fundoplication wraps part of your own stomach tissue around the food pipe, while LINX uses a small magnetic bead ring to support the valve. Both aim to stop acid leaking upwards.
Can I have an MRI scan if I have a LINX device?
Because LINX contains magnets, specific safety rules apply to MRI scans. Your medical team will explain which scans are safe and provide you with an implant card.
Do I have to pay to take part in this trial?
No, the study is funded by the National Institute for Health and Care Research (NIHR) and carried out within the NHS at no cost to you.
What happens if I change my mind after joining?
You are free to leave the study at any time. Your decision will not affect the quality of your regular NHS medical care.
How to find out more
Sheraz Markar
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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