RecruitingPHASE3INTERVENTIONAL

LINX vs Fundoplication

If you suffer from severe heartburn (reflux) that's not helped by usual treatments, surgery might be an option. This study, called GOLF, is comparing two keyhole operations: the standard fundoplication and a newer magnetic device called LINX. Fundoplication tightens the gullet to stop reflux, but can cause side effects like bloating. LINX uses a magnetic ring to do a similar job, and early studies suggest it might have fewer side effects. This research aims to find out which operation is better at controlling reflux, improving quality of life, and is more cost-effective. Around 460 patients across the UK and Europe will take part, with follow-up appointments over two years to track their progress.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University of Oxford

Enrolment target

460

Start

06 Mar 2025

Estimated completion

01 Jul 2029

Gastro-oesophageal Reflux Disease

What is this study about?

If you've been living with severe heartburn, also known as gastro-oesophageal reflux disease (GORD), you know how uncomfortable and disruptive it can be. While lifestyle changes and medicines often help, sometimes these aren't enough, and surgery becomes a serious consideration. This study is all about helping doctors understand which surgical option is best for patients like you.

Currently, the most common surgery for reflux is called a fundoplication. This is a keyhole operation where the top part of your stomach is wrapped around the lower end of your food pipe (oesophagus) to strengthen it and prevent acid from rising. It can be very effective, but some people experience issues like feeling bloated, having trouble swallowing, or their reflux symptoms coming back over time.

There's a newer keyhole procedure that uses a device called LINX. This is a small ring of magnetic beads placed around the lower part of your food pipe. It's designed to open when you swallow but close afterwards, stopping reflux. Early findings suggest LINX might cause fewer side effects than fundoplication while still offering good symptom relief. This study, called GOLF, aims to directly compare LINX and fundoplication to see which one gives patients the best results in terms of comfort, symptom control, and overall quality of life, as well as being cost-effective.

Key takeaways

This study compares two keyhole surgeries for severe heartburn: fundoplication and LINX.
It aims to find out which operation controls reflux better and causes fewer side effects.
Around 460 patients will be randomly assigned to one of the two surgeries.
Your health will be closely monitored for two years after the operation.
The study results will help improve guidelines for reflux surgery nationwide.

Who may be eligible?

This study is looking for adults aged 18 or older who have severe heartburn (reflux) that hasn't been properly controlled by medicines, or who can't tolerate the medicines. You would need to be considering surgery for your reflux. Doctors would need to confirm your reflux using tests like an endoscopy (looking inside your food pipe) or a pH test (measuring acid in your food pipe).

There are a few reasons you might not be able to join. For example, if you have other serious medical conditions that would make surgery unsafe, or if you're allergic to metals like titanium or nickel. You also can't have had previous surgery for reflux or stomach issues. Doctors will also check a test called an oesophageal manometry, which looks at how your food pipe muscles work, to make sure they're strong enough for the surgery.

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.

Are you 18 years old or older?
Is your severe heartburn (reflux) not well controlled by medicines?
Are you considering surgery for your reflux?
Do you have no known allergies to metals like titanium or nickel?
Have you not had previous surgery on your stomach or for reflux?

Answer every question to see your result.

What does participation involve?

If you're invited to take part in this study, you'll first have a discussion with your doctor and decide if it's right for you. If you agree, you'll be randomly assigned to receive either the fundoplication surgery or the LINX device. This decision is made by chance, like flipping a coin. Both operations are performed using keyhole surgery.

After your surgery, you'll have several follow-up appointments. These will typically be at 6 weeks, then 6 months, 12 months, and finally 24 months (two years) after your operation. At these appointments, doctors will check how you're feeling, how well your reflux is controlled, and if you're experiencing any side effects. They will also assess your overall quality of life. The total duration of your participation in the study, including all follow-up, will be two years.

Potential risks and benefits

Taking part in any clinical study means you could experience benefits, but also potential risks. The potential benefits of this study include receiving either a well-established surgical treatment or a newer alternative that might offer advantages. Your health will be closely monitored by medical professionals throughout the study. However, as with any surgery, there are risks involved, such as infection, bleeding, or side effects like difficulty swallowing or bloating, which the study will monitor. You also have the absolute right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guy's and St Thomas's NHS Foundation Trust, Guy's and St Thomas's Hospital
Verified postcode
Oxford, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust, St Mary's Hospital
Verified postcode
Oxford, United Kingdom· Recruiting
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Verified postcode
Oxford, United Kingdom· Recruiting
Oxford University Hospitals NHS Foundation Trust, Churchill Hospital
Verified postcode
Oxford, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is reflux?

Reflux, or heartburn, is when stomach acid flows back up into your food pipe (oesophagus), causing a burning feeling in your chest.

What is keyhole surgery?

Keyhole surgery uses small cuts and special instruments, rather than one large cut, to perform an operation, often leading to a quicker recovery.

Will I get to choose which surgery I have?

No, if you join this study, you'll be randomly assigned to either the fundoplication or LINX group, like picking from a hat.

How long will I be followed up for?

You will have follow-up appointments for two years after your surgery to check how you are doing.

What if I change my mind about taking part?

You have the right to leave the study at any time, for any reason, without needing to explain why, and it won't affect your future care.

How to find out more

Sheraz Markar, PhD, FRCS, MSc, MA

golf@nds.ox.ac.uk +44 07584039433 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.