LINX versus fundoplication for treating gastro-oesophageal reflux (GERD)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with symptomatic, objectively confirmed gastro-oesophageal reflux disease who are being considered for anti-reflux surgery are offered either a laparoscopic or robotic LINX device or a laparoscopic or robotic fundoplication. Eligible participants must be 18 or older, have objective evidence of reflux, a hiatal hernia no larger than 5 cm, and adequate oesophageal motility, while prior anti-reflux surgery excludes patients. The trial compares symptom control, quality of life, and surgical complications such as gas bloat and swallowing difficulty between the two surgical approaches. The programme is led by the University of Oxford in collaboration with major UK centres.

Why it matters

Who can join: the full rules

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.

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

Where it's running

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

Study contacts

• Study coordinator: Sheraz Markar, PhD, FRCS, MSc, MA
• Email: golf@nds.ox.ac.uk
• Phone: +44 07584039433

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.