Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
Academic Directorate of General Surgery, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Tech Coloproctol. 2023 Feb;27(2):117-124. doi: 10.1007/s10151-022-02724-8. Epub 2022 Nov 9.
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.
The RadiO fRequency ablatION for haemorrhoids (ORION) trial will be a pragmatic multicentre patient/assessor-blind 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.
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.
ISRCTN14474552.
痔疮很常见，会严重影响个人和工作生活。那些症状更严重或对保守治疗无反应的患者可能需要手术。目前的手术技术会引起一定程度的术后不适，可能会延迟恢复正常活动。更激进的手术程序复发率较低，但疼痛程度较高。射频消融（RFA）是一种新的技术，越来越受欢迎，具有一些假设的好处，包括减轻疼痛和减少复发。然而，现有的证据有限。国家卫生与临床卓越研究所（National Institute for Health and Clinical Excellence）最近的一篇综述建议，在国家卫生服务机构进一步投资之前，应进行更多的研究，包括随机对照试验。我们的目的是评估 RFA 在复发方面是否至少与现有的手术干预一样有效，但在疼痛方面是否优于有症状的 II 级和 III 级痔疮患者。
RadiO fRequency ablatION for haemorrhoids (ORION) 试验将是一项实用的多中心患者/评估者盲法平行组对照试验，并进行经济评估。目标样本量为 376 名参与者（每组 188 名），基于两个主要终点：（i）复发的非劣效性设计和（ii）疼痛的优效性设计，在 7 天内。将招募 16 家 NHS 医院的 II 级或 III 级痔疮患者，并随机（1:1）分为 RFA 组或外科医生选择的手术组。
研究结果将为 II-III 级痔疮的治疗提供未来的实践依据，并为 NHS 未来对 RFA 的投资提供证据。
ISRCTN85451065。
