About the Trial

Background

Haemorrhoids are common, affecting as many as 1 in 3 of the population, and can cause symptoms including discomfort and bleeding, and are a common reason for review in a surgical clinic. Over 20,000 operations are carried out each year in England alone. Repeated visits to health care services as well as prolonged recovery after some interventions represents a significant disruption to the personal and working lives of a large proportion of the population.

Treatments for haemarrhoids

Interventions, for those whose symptoms remain after trying conservative management in the form of diet and habit modification, are influenced mainly by the degree of prolapse. These interventions range from rubber band ligation (RBL), which appears safe, and is easy to carry out, to haemorrhoidal artery ligation, stapled haemorrhoidopexy or haemorrhoidectomy. All interventions are available on the NHS.

Radiofrequency ablation

An alternative procedure to treat haemorrhoids is the use of radiofrequency ablation (RFA). RFA is primarily intended for use in patients whose haemorrhoid has failed to respond to less invasive outpatient procedures such as RBL as well as an alternative to operative procedures for those with a higher degree of prolapse where office procedures are likely to be ineffective. RFA is available to the NHS through the Rafaelo® device and has many potential advantages over the other surgical interventions and is therefore increasing in popularity. As the intervention does not excise tissue or generate excessive heat it should result in minimal discomfort and has been suggested to be faster than excisional treatments with a more rapid recovery. The evidence base for these claims is however limited, mainly from small cohort studies in specialist settings. More importantly, the promising longer-term efficacy has not been subject to a randomised comparison.