GOLF Study Patient Information
Double-blind randomised controlled trial for treatment of Gastro-Oesophageal reflux disease; Linx management system vs. Fundoplication (GOLF)
Plain English Summary:
Gastro-oesophageal reflux disease (GORD) is a common condition in which acid from the stomach passes back (reflux) into the gullet (oesophagus). It typically occurs due to weakening of the ring of muscle at the bottom of the oesophagus (the lower oesophageal sphincter). GORD is more common in older people and in women, however, can affect anyone of any age or ethnicity. The most common symptoms are heartburn and an unpleasant taste in the back of the mouth. Although GORD may be only an occasional nuisance for most people, there are others in whom it has a severe impact upon their quality-of-life. It can lead to several complications, including ulceration and narrowing of the oesophagus. The most serious complication (2 in 10 people) is called Barrett’s oesophagus; a change in the lining of the oesophagus that increases the risk of developing oesophageal cancer. In most cases, GORD can be controlled with self-help measures and medication. However, there are instances in which surgery is recommended. The current best surgical treatment for GORD is called a fundoplication. This operation, which is carried out through keyhole (laparoscopic) surgery, tightens the lower oesophagus to prevent acid reflux. Fundoplication has an excellent safety profile and produces an improvement in the quality of life of many patients. However, there are a significant number of patients who suffer from gas bloating (8 out of 10 people), difficulty swallowing (2 out of 10 people) and a recurrence of their GORD symptoms (6 out of 10 people) after fundoplication. As an alternative to fundoplication, some surgeons have started to use a device called LINX, through a similar keyhole operation. LINX is a magnetic band that wraps around the lower part of the oesophagus to prevent acid reflux. Small scale studies suggest that LINX may cause fewer complications than fundoplication, albeit at the cost of a more modest improvement in quality-of-life. However, before LINX can safely overtake fundoplication as the primary means of surgically treating GORD, there is a need to generate more conclusive evidence. In order to meet this need, we have designed a multi-centre study which aims to determine whether the LINX procedure achieves similar reflux control and improves symptoms when compared to fundoplication. We intend to measure (1) quality of life, (2) complications related to the operation, including the need for additional treatment, (3) the financial cost effectiveness and (4) the presence of acid in the lower oesophagus. Given that there is no clear ‘better’ surgical option between the two options, 230 patients will be randomly allocated to receive either fundoplication or the insertion of the LINX device. This study will be conducted across 16 UK and 4 European large specialist surgical centres. Patients participating in the study will be followed up at regular intervals (6 weeks, 6 months, 12 months and 24 months) to better understand which treatment option offers the best results. Moreover, we will implement a quality assurance programme within participating study centres to ensure that the procedures are completed to a high-quality standard. As part of this, all procedures will be recorded and assessed. We anticipate that the study results, which will incorporate a full patient and public involvement programme, will change national and international guidelines for GORD treatment.
Abstract:
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.