Does the LINX procedure achieve similar reflux control and improve postoperative symptoms, specifically gas bloating and inability to belch, when compared to laparoscopic fundoplication?

Plain English Summary

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

Prof Sheraz Markar
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) 7407 894087
Email	sheraz.markar@nds.ox.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centres

Sponsor information

University of Oxford
University/education

Joint Research Office
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom

Email	RGEA.Sponsor@admin.ox.ac.uk
Website	http://www.ox.ac.uk/
"ROR"	https://ror.org/052gg0110

Funders

Funder type

Government

Results and Publications

Editorial Notes

28/05/2024: Study's existence confirmed by the NIHR.