The ORION Trial
Research type
Research Study
Full title
RadiO fRequency ablatION for haemorrhoids (ORION)
IRAS ID
300449
Contact name
Steven Brown
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
3 years, 6 months, 31 days
Research summary
Piles (also referred to as haemorrhoids) are very common and in some cases require surgery. There are multiple types of operations to treat the piles however, none are perfect. Some are good at curing the piles, but can leave lasting damage to the body. Others may be less painful but the piles may return. There are ‘newer’ treatments, but these are more expensive than the traditional treatments.
One new treatment for piles is called radiofrequency ablation. This works by using radio waves that destroy the pile. There has been a small amount of testing done on this new treatment, but more testing is needed. From the testing that has been done, we know that it is safe, not too painful and patients recover from the surgery quickly. However, not enough research has been done on this treatment for us to confirm this. Therefore, the purpose of this study is to test if radiofrequency ablation is at least as good as the traditional surgeries for curing piles and at the same time easier for the patient to recover from. If it is, these results could help inform the NHS that this treatment is worth the money, which could help future patients.
To do this, we will identify adult patients that are going to undergo surgery for piles at NHS hospitals. The study will be explained to them and if they choose to take part, they will be randomly assigned to have either the new radiofrequency ablation surgery or whatever other type of operation that the surgeon thinks is best. The patient will not know which surgery they have had. After their surgery, each patient will be followed up at numerous time points, up to a year after surgery, to see how they are recovering.
REC name
London - Queen Square Research Ethics Committee
REC reference
21/LO/0762
Date of REC Opinion
13 Dec 2021
REC opinion
Further Information Favourable Opinion