Girling, C. orcid.org/0000-0003-4216-214X, Lee, M.J., Vimalchandran, D. et al. (8 more authors) (2023) Protocol for the ORION trial (RadiO fRequency ablatION for haemorrhoids): a randomised controlled trial. Techniques in Coloproctology, 27 (2). pp. 117-124. ISSN 1123-6337
Abstract
Background Haemorrhoids are common and can significantly impact the personal and working lives of individuals. Those with more severe symptoms and those not responding to conservative management may require surgery. Current surgical techniques are associated with a degree of postoperative discomfort which may delay return to normal activity. Recurrence is lower in more radical procedures but resulting pain is higher. Radiofrequency ablation (RFA) is a new technique that is gaining popularity and has several hypothesised benefits, including reduced pain and recurrence. However, available evidence is limited. A recent overview from the National Institute for Health and Clinical Excellence recommended more research, in the form of randomised controlled trials, be carried out before further investment is made by national health services. Our aim is to assess whether RFA is at least as good in terms of recurrence as existing surgical interventions, but superior in terms of pain, for patients with symptomatic grade II and III haemorrhoids. Methods The RadiO fRequency ablatION for haemorrhoids (ORION) trial will be a pragmatic multicentre patient/assessorblind parallel group-controlled trial with economic evaluation. The target sample size is 376 participants (188 per arm) and is based on two co-primary endpoints: (i) a non-inferiority design for recurrence and (ii) superiority design for pain at seven days. Participants with grade II or III haemorrhoids will be recruited in 16 National Health Service hospitals and randomised (1:1) to either RFA or surgeon’s choice of surgery. Conclusions Results will inform future practice for the treatment of grade II–III haemorrhoids and provide evidence for national health services on future investments in RFA.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2022 The Authors. This is an Open Access article distributed under the terms of the Creative Commons Attribution Licence (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
Keywords: | Haemorrhoids; Randomised controlled trial; Radiofrequency ablation; Surgical procedure |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) > ScHARR - Sheffield Centre for Health and Related Research |
Funding Information: | Funder Grant number NIHR Evaluation Trials and Studies Coordinating Centre NIHR131861 |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 11 Nov 2022 11:16 |
Last Modified: | 18 Jan 2023 11:46 |
Status: | Published |
Publisher: | Springer Science and Business Media LLC |
Refereed: | Yes |
Identification Number: | 10.1007/s10151-022-02724-8 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:193272 |