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.
Lay summary of study results:Why was the trial done?
Haemorrhoids affect up to 1 in 3 people. They can cause discomfort and bleeding, often leading to surgery. In England alone over 20,000 operations are carried out every year.
The ORION trial was designed to see if a newer treatment called Radiofrequency Ablation (RFA) works well enough to be an option for the standard operations currently offered by the NHS.What did we do?
383 adults with second- or third-degree haemorrhoids (those that are enlarged or protrude) took part in the trial. To ensure the study was fair, patients were randomly assigned to one of two groups and were not told which treatment they received:
• Group A: Received the new RFA treatment.
• Group B: Received Standard Care (the surgeon decided from three procedures that are currently offered: haemorrhoidectomy, haemorrhoid artery ligation or stapled haemorrhoidopexy).What were the results?
We looked at two main outcomes: pain one week after surgery and whether the haemorrhoids came back (recurrence) after one year.
• Pain: There was no significant difference in pain 7 days after surgery between RFA and standard care.
• Recurrence: At 12 months, symptoms returned for 47% of people who had RFA, compared to 39% of those who had standard care surgery. While RFA had a higher recurrence rate, the difference was not large enough to definitively say it was worse than standard care. At the same time, this study also cannot rule out an important increase in the number of uncured haemorrhoids.
• Recovery: People who had RFA took more time off work (about 2.6 days more on average) than those who had standard care surgery.
• Cost to NHS: RFA was found to be cheaper for the healthcare system because the procedure is faster and uses less expensive equipment.Summary
Overall, the trial found that RFA is a safe option and costs the health system less. However, it did not lead to less pain 7 days after surgery and patients may experience a slightly higher chance of their haemorrhoids returning within a year.How can I find out more?
If you would like to find out more, please visit the ORION website:
https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.oriontrial.co.uk%2F&data=05%7C02%7Cqueensquare.rec%40hra.nhs.uk%7C8092e8f76cc54358823808ded1258599%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639178156251381205%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=59JIQaJQyVtIDc68A4QIeKdgoms66HfpXEp66rfd73M%3D&reserved=0We will keep this website update to date with publications and other information about the trial.
Thank you for taking part in the ORION Trial!
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