For haemorrhoids that are considered appropriate surgery, does radiofrequency ablation reduce short-term pain, and prevent long-term recurrence compared to current recommended interventions?
| ISRCTN | ISRCTN14474552 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14474552 |
| IRAS number | 300449 |
| Secondary identifying numbers | CPMS 50709, NIHR131861, IRAS 300449 |
- Submission date
- 17/12/2021
- Registration date
- 17/12/2021
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
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.
Who can participate?
Adult patients who are going to undergo surgery for piles at NHS hospitals
What does the study involve?
Participants 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.
What are the possible benefits and risks of participating?
There are no guaranteed benefits to participating in this research. Participants will receive the appropriate health care by their consultant whether they choose to participate in the study or not. We do not know which type of surgery will be better in the long term. This is the reason for doing this research. By taking part in this study, participants will be directly helping us to inform the treatment of future patients diagnosed with haemorrhoids that need surgical treatment. All treatments offered in the trial are routinely offered in the NHS; both would be options offered to participants if they did not take part in the trial and are considered to be safe treatments. Although, RFA is not available in all NHS Trusts. There are possible side effects to all surgical treatment options for haemorrhoids, as well as possible side effects of anesthetic. These are listed in the Participant Information Sheet or by talking to your care team. Participants will be asked to give up some of their time to answer the follow-up questions, they may also be asked some sensitive questions about their symptoms.
Where is the study run from?
Sheffield Teaching Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
July 2021 to December 2025
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Prof Steven Brown, steven.brown13@nhs.net
Study Team, orion@sheffield.ac.uk
Contact information
Scientific
Sheffield Teaching Hospital NHS Foundation Trust
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 114 2715030 |
|---|---|
| steven.brown13@nhs.net |
Public
Clinical Trials Research Unit
School of Health and Related Research
University of Sheffield
C/O Regents court, 30 Regent street
Sheffield
S1 4DA
United Kingdom
Public
Clinical Trials Research Unit
School of Health and Related Research
University of Sheffield
C/O Regents court, 30 Regent street
Sheffield
S1 4DA
United Kingdom
| orion@sheffield.ac.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 40827 ORION PIS v1.1 12Nov2021.pdf |
| Scientific title | RadiO fRequency ablatION for haemorrhoids (ORION) |
| Study acronym | ORION |
| Study objectives | Radiofrequency ablation will be non-inferior to other current surgical techniques for treating haemorrhoids, and superior in terms of recurrence and pain. |
| Ethics approval(s) | Approved 13/12/2021, London Queen Square REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44 2071048109; queensquare.rec@hra.nhs.uk), ref: 21/LO/0762 |
| Health condition(s) or problem(s) studied | Haemorrhoid surgery |
| Intervention | Potential patients will be referred to a NHS recruiting centre for the treatment of grade II/III haemorrhoids. Potential patients will fall into two groups: 1. Patients that present to the surgical outpatient clinic that have symptomatic haemorrhoids. They will have failed conservative therapies and therefore the treatment suggested would be office therapy such as Rubber Band Ligation (RBL) and would therefore likely be an example of grade II haemorrhoids. If the RBL treatment fails, they will be offered entry into the trial. 2. Patients that present to the surgical outpatient clinic with symptomatic haemorrhoids but are considered unsuitable for office therapies such as RBL. These patients would be considered to have grade III haemorrhoids. They will also have failed conservative therapies. These patients will be offered into the trial. These patients will be identified and a participant information sheet will be posted to them. The patient will attend an outpatient clinic visit where their eligibility for the trial will be assessed. If the patient chooses to take part, informed consent will be taken by research personnel. If the patient is consented onto the study, baseline measures will be taken via questionnaires asked by the research staff in clinic. Alternatively, patients can be recruited via postal consent. A PIS will be posted out these patients, in addition to two copies of the postal consent form (one for the patient to keep and one to post back to the research team). Once the patient has read the PIS, after 24 hours, if the patient agrees to take part in the trial, they will sign both copies of the consent form. Once the signed consent form has been returned, a member of the delegated research team will call the patient to complete the postal consent review form. The research team may also call the patient prior to receiving the consent form to answer any questions. Patients will then be randomised into one of the two treatment groups: Radiofrequency Ablation or the surgeon's choice of treatment (Haemorrhoidectomy, Staple Haemorrhoidpexy or Haemorrhoidal Artery Ligation). The baseline measures asked will be asked on the day of surgery due to the wait time between consent and surgery potentially leading to changes in the patient's responses. Participants will be asked to complete follow-up questionnaires on day 1, 7 and 21 following their intervention via telephone or postal self-report assessment. Six weeks after their surgery, participants will attend a routine clinic visit. The timing of this follow-up may vary based upon appointment availability at the individual collaborating centres. Twelve months after the intervention, the participant will complete the final set of follow-up questionnaires via telephone or postal self-report assessment. Also at twelve months, a member of the research team will write to the participant's GP and check their medical notes for information on further haemorrhoid treatment as a supplement to this follow-up. The patient's surgeon will also be asked about any further treatment. |
| Intervention type | Other |
| Primary outcome measure | 1. Recurrence at 12 months post procedure measured using patient records 2. Pain measured by Numeric Pain Rating Scale (NPRS) daily over 7 days post procedure |
| Secondary outcome measures | 1. Pain is measured by the 'Numeric Pain Rating Scale' at baseline (day of surgery), 1 day, 7 days, 21 days 6 week and 1 year post procedure 2. Incontinence score is measured by Vaizey incontinence score baseline (day of surgery), 6 weeks post surgery, 1 year post surgery 3. Quality of life measured by EQ5D: baseline (day of surgery), 1 day, 7 days, 21 days 6 week and 1 year post procedure 4. Severity of haemorrhoid measured by haemorrhoid severity score baseline (day of surgery), 6 weeks post surgery, 1 year post surgery 5. Operation details: day of surgery 6. Recurrence of symptoms measured by complications review interview; 6 weeks post surgery, 1 year post surgery 7. Economic impact: days of work lost questionnaire: 6 weeks post surgery, 1 year post surgery 8. Recurrence of hemorrhoid measured by a triangulation of participant question based on Hubble Trial, surgeons questionnaire and GP questionnaire; week 6 post surgery and 1 year post surgery 9. Haemorrhoid severity measured by clinical appearance at proctoscopy: 6 weeks post surgery |
| Overall study start date | 01/07/2021 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 376; UK Sample Size: 376 |
| Total final enrolment | 384 |
| Key inclusion criteria | Current inclusion criteria as of 15/07/2022: 1. Adults aged 18 years or over with symptomatic grade II or grade III haemorrhoids 2. And patients who have failed conservative management for haemorrhoids (diet and lifestyle changes) and want further intervention 3. And/or patients who have failed either one episode of Rubber Band Ligation (RBL) or have grade III haemorrhoids considered inappropriate for RBL treatment and/or have grade II or III haemorrhoids which the surgeon feels operative intervention is appropriate Previous inclusion criteria: 1. Adults aged 18 years or over with symptomatic grade II or grade III haemorrhoids 2. And patients who have failed conservative management for haemorrhoids (diet and lifestyle changes) and want further intervention 3. And patients who have failed either one episode of Rubber Band Ligation (RBL) or have grade III haemorrhoids considered inappropriate for RBL treatment |
| Key exclusion criteria | 1. Patients with known perianal sepsis, inflammatory bowel disease, anal or colorectal malignancy, pre-existing sphincter injury 2. Patients with an immunodeficiency (HIV or other medical issue) 3. Patients who are unable to have general or spinal anaesthetic 4. Patients currently taking Warfarin, Clopidogrel or any other hypercoagulability condition 5. Pregnant women 6. Patients with a pacemaker 6. Patients unable to give full informed consent 7. Patients previously randomised to this trial 8. Patients participating in any other clinical trial |
| Date of first enrolment | 01/03/2022 |
| Date of final enrolment | 31/01/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
- Wales
Study participating centres
Herries Road
Sheffield
S5 7AU
United Kingdom
Rom Valley Way
Romford
RM7 0AG
United Kingdom
Darenth Wood Road
Dartford
DA2 8DA
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Basildon
SS16 5NL
United Kingdom
London
NW1 2PG
United Kingdom
Liverpool
L9 7AL
United Kingdom
Cardiff
CF14 4XW
United Kingdom
De Crespigny Park
Denmark Hill
London
SE5 8AB
United Kingdom
Blackburn
BB2 3HH
United Kingdom
Rake Lane
North Shields
NE29 8NH
United Kingdom
Poole
BH15 2JB
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Torquay
TQ2 7AA
United Kingdom
Isleworth
TW7 6AF
United Kingdom
Leigh
WN7 1HS
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Marshalls Cross Road
St. Helens
WA9 3DA
United Kingdom
Sponsor information
Hospital/treatment centre
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
| Phone | +44 1142265941 |
|---|---|
| dipak.patel12@nhs.net | |
| Website | http://www.sth.nhs.uk/ |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Government
No information available
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository, Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request. The dataset will be stored at the University of Sheffield on a secure network. Details of the data sharing requirements are not yet available. Various details of the dataset will be included in the publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 12/11/2021 | 17/12/2021 | No | Yes |
| Protocol file | version 1.2 | 15/12/2021 | 17/12/2021 | No | No |
| Protocol file | version 1.4 | 19/04/2022 | 15/07/2022 | No | No |
| Protocol article | 09/11/2022 | 10/11/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.2 | 03/08/2023 | 01/03/2024 | No | No |
| Statistical Analysis Plan | version 4.0 | 08/02/2023 | 01/03/2024 | No | No |
| Protocol file | version 3.3 | 30/07/2024 | 06/03/2025 | No | No |
Additional files
Editorial Notes
06/03/2025: The following changes were made to the trial record:
1. Uploaded protocol v3.3 (not peer-reviewed) as an additional file.
2. Contact details updated.
01/03/2024: The following changes were made to the study record:
1. Total final enrolment added.
2. Protocol and SAP uploaded.
3. The study participating centres were updated to remove Worcestershire Royal Hospital and Salford Hospital, and add Countess Of Chester Hospital and St Helens Hospital.
04/01/2024: The following changes were made to the study record:
1. The overall study end date was changed from 31/01/2025 to 31/12/2025.
2. The intention to publish date was changed from 01/01/2026 to 31/12/2026.
04/10/2023: The recruitment end date was changed from 31/08/2023 to 31/01/2024.
13/09/2023: The public contact was updated.
03/05/2023: The recruitment end date was changed from 31/05/2023 to 31/08/2023.
10/11/2022: Publication reference added.
21/07/2022: The trial participating centres were updated to add Aintree University Hospital, University Hospital of Wales, Royal Blackburn Hospital, North Tyneside General Hospital, Poole Hospital, Salford Royal, Royal Bolton Hospital, Torbay Hospital, West Middlesex University Hospital, Worcestershire Royal Hospital, and Leigh Infirmary.
15/07/2022: The inclusion criteria were updated. Uploaded protocol (not peer reviewed).
17/12/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
