The place of minimal access surgery amongst people with gastro-oesophageal reflux disease - extended follow-up REFLUX-2

The initial REFLUX trial assessed the effectiveness and cost-effectiveness of early laparoscopic surgery (fundoplication) compared with continued medial management for people with gastro-oesophageal reflux disease (GORD) based on follow-up to 12 months after surgery ( or the equivalent time in the medically managed group). 810 people with GORD were recruited from 21 centres across the UK. The report of the first stage described benefits for fundoplication in terms of condition-specific measure of outcome and of the EQ-5D at one year post-surgery. However judgements about effectiveness and cost-effectiveness depend on what assumptions are made about longer-term differential effects between the two types o management. Judged on changes between three months and a year after surgery, it is plausible that the differences between the groups may lessen over time, but the opposite could also be the case. To address this issue, longer-term follow-up of participants is now underway in this second stage. The extended follow-up of REFLUX (REFLUX-2) will evaluate the longer term clinical effectiveness and cost-effectiveness of early laparoscopic surgery compared with continued medical management. Annual follow-up of participants is being undertaken using postal questionnaires until all trial participants have had at least five years of follow-up. The questionnaire includes sections on symptoms of reflux, the EQ-5D, the SF-36, attendance at GP or hospital for reflux symptoms and medications for reflux symptoms.