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

C Girling1, M J Lee1,2, D Vimalchandran3

  • 1Clinical Trials Research Unit, School of Health and Related Research, The University of Sheffield, Sheffield, UK.

Techniques in Coloproctology
|November 9, 2022
PubMed
Summary

Radiofrequency ablation (RFA) is being studied as a new treatment for hemorrhoids. This trial compares RFA to traditional surgery to see if it reduces pain and recurrence for patients with grade II and III hemorrhoids.

Keywords:
HaemorrhoidsRadiofrequency ablationRandomised controlled trialSurgical procedure

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Area of Science:

  • Colorectal surgery
  • Minimally invasive procedures
  • Medical device technology

Background:

  • Hemorrhoids significantly impact quality of life, often necessitating surgical intervention for severe or refractory cases.
  • Current surgical treatments for hemorrhoids can involve considerable postoperative pain and a delayed return to normal activities.
  • Radiofrequency ablation (RFA) presents a novel approach with hypothesized benefits of reduced pain and recurrence, though robust evidence is limited.

Purpose of the Study:

  • To evaluate if radiofrequency ablation (RFA) is non-inferior to existing surgical interventions for hemorrhoid recurrence.
  • To determine if RFA offers superior pain reduction compared to traditional surgery at seven days post-procedure.
  • To provide evidence for national health services regarding the efficacy and cost-effectiveness of RFA for symptomatic grade II and III hemorrhoids.

Main Methods:

  • A pragmatic, multicenter, patient/assessor-blind, parallel-group, controlled trial with economic evaluation (The RadiO fRequency ablatION for haemorrhoids - ORION trial).
  • Recruitment of 376 participants (188 per arm) with grade II or III hemorrhoids across 16 National Health Service hospitals.
  • Randomization of participants (1:1) to either radiofrequency ablation (RFA) or surgeon's choice of conventional surgery.

Main Results:

  • Co-primary endpoints include non-inferiority for recurrence and superiority for pain at seven days.
  • Data collection and analysis are ongoing to compare outcomes between RFA and conventional surgical methods.
  • Results will guide clinical practice and inform healthcare policy on the adoption of RFA for hemorrhoid treatment.

Conclusions:

  • The ORION trial aims to establish the efficacy of RFA in managing symptomatic hemorrhoids.
  • Findings will inform clinical decision-making for grade II and III hemorrhoid treatment.
  • Evidence generated will support national health services in making informed investment decisions regarding RFA technology.