The ORION Trial

RadiO fRequency ablatION for haemorrhoids (ORION). A Pragmatic multicentre patient-/assessor-blind parallel-group individual participant randomised (1:1 allocation) randomised controlled trial.

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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. 

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. 

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.

The ORION Trial

RFA has not been tested enough for us to be sure it is as good as some suggest, and the cost is higher than that of other interventions. The aim of the ORION trial is to assess whether RFA is as efficacious as existing methods of treating haemorrhoids and if it is also superior in terms of pain and recurrence. 

ORION will be a full-scale trial that compares RFA’s effectiveness with the surgeon’s choice of surgery for patients whose haemorrhoids are severe enough to warrant surgery. The control arm of the trial will be the surgeon’s choice of any of the three most used surgeries – haemorrhoidal artery ligation, stapled haemorrhoidopexy or haemorrhoidectomy – and the intervention arm will be surgery using RFA. Patients will be randomised to either arm. 

Central Study Staff

Steven Brown

Chief Investigator

Sheffield Teaching Hospitals NHS Foundation Trust

steven.brown13@nhs.net

Daniel Hind

Trial Oversight 

University of Sheffield

d.hind@sheffield.ac.uk

Carla Girling

Trial Manager

University of Sheffield

c.girling@sheffield.ac.uk

Rebecca Milner

Trials Support Officer

University of Sheffield

rebecca.milner@sheffield.ac.uk

Co-Applicants

David Jayne

Professor 

University of Leeds

Dale Vimalchandran

RCS Subspeciality Lead Colorectal Surgery

Countess of Chester Hospital NHS Foundation Trust

Daniel Hind

Assistant Director

Sheffield CTRU, ScHARR, The University of Sheffield

Matthew Lee

NIHR Clinical Lecturer

The University of Sheffield

Mike Bradburn

Senior Statistician 

Sheffield CTRU, ScHARR, The University of Sheffield

Shaun Stancliffe 

Patient Representative

 

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