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

INTERVENTION: 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‐reflu Xsurgery with gastro‐oesophageal reflu Xdisease (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 LIN Xprocedure 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. CONDITION: Gastro‐oesophageal reflu Xdisease ; Digestive System PRIMARY OUTCOME: Symptomatic GORD and health‐related quality of life (HRQL) assessed using the GORD‐HRQL questionnaire at 24 months following surgery SECONDARY OUTCOME: 1. Prevalence of gas bloating measured using participant‐reported outcomes/GORD‐HRQL and Foregut Symptom Questionnaire at 24 months postoperatively; 2. Prevalence of inability to belch measured using participant‐reported outcomes/GORD‐HRQL and Foregut Symptom Questionnaire at 24 months postoperatively; 3. Prevalence of symptomatic GORD, inability to belch and gas bloating measured using participant‐reported outcomes/GORD‐HRQL and Foregut Symptom Questionnaire at 6 weeks, 6 and 12 months after surgery; 4. Severity of dysphagia and regurgitation measured using participant‐reported outcomes/GORD‐HRQL questionnaire at 6 weeks, 6, 12 and 24 months postoperatively; 5. Global HRQL measured using participant‐reported outcomes/EQ‐5D‐5L questionnaire at 6 weeks, 6, 12 and 24 months postoperatively; 6. Utilisation of anti‐GORD medications measured using participant‐reported outcomes/questionnaire at 6 weeks, 6, 12 and 24 months postoperatively; 7. 24‐hour pH measurement measured using participant’s medical records/24‐hour pH measurement or BRAVO test at 12 months postoperatively; 8. 30‐day, 90‐day, 12 and 24‐month postoperative complication rates, including reoperation and endoscopic reintervention, measured using participant’s medical records/postoperative outcomes; 9. Cost‐effectiveness of both treatments as measured by incremental cost per quality‐adjusted life year (QALY) at 6 weeks, 6, 12 and 24 months postoperatively 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‐reflu Xsurgery 4. Symptomatic and objectively defined GORD; endoscopy with appearances or biopsies consistent with reflu Xoesophagitis, 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.