Double-blind randomised controlled trial for treatment of Gastro-Oesophageal reflux disease; LINX management system vs Fundoplication (GOLF)
Gastro-oesophageal reflux disease
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.
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.
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