Evidence map›Paper›PMID 36352146›Full record

ArticleTechniques in coloproctology2023

Protocol for the ORION trial (RadiO fRequency ablatION for haemorrhoids): a randomised controlled trial.

C Girling, M J Lee, D Vimalchandran, D J Jayne, S Stancliffe, A Wailoo, M Bradburn, D Hind, M Bursnall, L K Robinson and 1 more

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Techniques in coloproctology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 4 citations in OpenAlex.

  1. Radiofrequency Ablation for Hemorrhoidal Disease.Life (Basel, Switzerland) · 2026
    Review
  2. Article
  3. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 1 country.

C GirlingClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.ORCID 0000-0003-4216-214X
M J LeeClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
D VimalchandranCountess of Chester Hospital NHS Foundation Trust, Chester, UK.
D J JayneUniversity of Leeds, Leeds, UK.
S StancliffeClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
A WailooClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
M BradburnClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
D HindClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
M BursnallClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
L K RobinsonClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.
S R BrownClinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK. steven.brown13@nhs.net.
University of Sheffield · GBSheffield Teaching Hospitals NHS Foundation Trust · GBCountess of Chester Hospital NHS Foundation Trust · GBUniversity of Leeds · GB

Funding

Health Technology Assessment Programme NIHR131861
6 · The paper itself

Abstract

backgroundHaemorrhoids 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.

methodsThe 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.

conclusionsResults will inform future practice for the treatment of grade II-III haemorrhoids and provide evidence for national health services on future investments in RFA.

trial registrationISRCTN14474552.

Indexed as

HemorrhoidsRadiofrequency AblationEquivalence Trials as TopicHumansLigationPainPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicState MedicineHaemorrhoidsRadiofrequency ablationRandomised controlled trialSurgical procedure

Identifiers

PMID36352146
PMCPMC9839800
OpenAlexW4308627419

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.