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

QUESTION: Does the LINX procedure achieve similar reflux control and improve postoperative symptoms, specifically gas bloating and inability to belch, when compared to laparoscopic fundoplication? BACKGROUND: Gastro-oesophageal reflux disease (GORD) represents a significant burden on the Western healthcare system, affecting up to 20% of adults. Laparoscopic fundoplication is currently the gold standard surgical treatment for managing GORD, the late complications include gas bloating, dysphagia, and recurrence of reflux. The LINX procedure involves laparoscopic placement of the LINX device around the distal oesophagus and comprises titanium beads with magnets in the centre that augment lower oesophageal tone and thus prevent reflux. AIMS: This study aims to determine whether the LINX procedure achieves similar reflux control and improves postoperative symptoms, specifically gas bloating and inability to belch, when compared to fundoplication at 24 months after surgery. Secondary aims are to compare the prevalence and severity of reflux, gas bloating and inability to belch at 6 weeks, 6, and 12 months, regurgitation, dysphagia, global health-related quality of life (HRQL) and utilisation of anti-GORD medications at 6 weeks, 6, 12 and 24 months, objective assessment of lower oesophageal acid exposure using 24hr pH manometry or BRAVO test at 12 months and 30-day, 90-day, 12 and 24-month complication rates. The mechanistic research will aim to provide a unique understanding of technical surgical factors that underpin patient reported outcome measures (PROMS) after anti-reflux surgery, through detailed video analysis with robust surgical quality assurance (SQA). METHODS: A prospective, multi-centre, pragmatic, double-blind phase III RCT design will be utilised, randomising patients 1:1 between laparoscopic LINX procedure and fundoplication. The setting will be at least 16 UK and 4 European large upper gastro-intestinal surgical centres. With the support of an integrated QuinteT Recruitment Intervention (QRI) to optimise recruitment, we will recruit 460 patients recommended for anti-reflux surgery with GORD. Patients will be randomised 1:1 to receive either laparoscopic LINX procedure or fundoplication. The primary outcome is assessment of symptomatic GORD and HRQL using the GORD-HRQL questionnaire at 24 months following surgery, and key secondary outcomes are prevalence of inability to belch and gas bloating at 24 months. Patients will be followed-up at baseline, 6 weeks, 6, 12 and 24 months. All procedures will be recorded, and videos will be annotated, these will then be compared with data relating to post-operative complications and PROMS. TIMELINES The total length of the trial is 60 months. Recruitment will last 24 months and there will be a formal stop/go review of the internal pilot in month 14 of the project (8th month of recruitment) to ensure that a minimum of 15 centres are active and recruiting at least 1-3 patients/centre/month. Data from the patients in the internal pilot phase will be included in the final analysis. IMPACT We anticipate that the study results will change national guidelines for GORD and thus affect over 2000 patients who are treated with surgery in the UK annually. The findings are likely to extend beyond the UK and dissemination will be through publications, presentations, and appropriate use of media. We have incorporated a full patient and public involvement programme.