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The Rafaelo® procedure
Radiofrequency ablation of haemorrhoids under local anaesthesia
Though haemorrhoids are an extremely common problem (up to 50% of people experience them at some point in their lives), many sufferers are reluctant to seek medical attention—not only because the condition involves an intimate area, but also because they worry that treatment may be painful or cause complications of its own.
Enter Rafaelo®, a revolutionary procedure for ablating haemorrhoids under local anaesthesia. Rafaelo® uses a specially designed probe to apply targeted RF energy to the pile, ablating it through thermocoagulation while leaving the surrounding tissue intact. The procedure is indicated for internal haemorrhoids, i.e., originating above the dentate line, with or without external prolapse.
Whereas conventional haemorrhoidectomies often involve weeks of painful recovery and carry the risks associated with any surgical procedure, patients undergoing minimally invasive radiofrequency ablation are typically able to resume normal activities in the following days. Complications of Rafaelo® are rare; if anything, patients experience only minor post-treatment pain that is easily managed with over-the-counter analgesics.
Advantages for patients
- Minimally invasive: no incision = no risk of anal incontinence
- Estimated treatment time: 15 minutes
- Local anaesthesia
- Little to no post-treatment discomfort (OTC pain management)
- Low risk of recurrence or complications
- No long convalescence periods: most patients can resume daily activities immediately
- High level of patient satisfaction
Advantages for practitioners
- Suitable for Grade II, III and early Grade IV haemorrhoids
- Minimally invasive method ideal for outpatient or day-case care
- Easy-to-perform technique with immediately visible results
- Local anaesthesia allows patients to give feedback on how they feel
- No post-operative wound care
- Over 90% success rate
Treatment protocol
Radiofrequency haemorrhoid ablation is typically a ten to fifteen-minute procedure, performed on an outpatient basis. The thermocoagulation technique is easy to perform and yields immediately visible results.
1. Apply lidocaine gel to the anoscope and insert.
2. Inject 3-6 ml of local anaesthetic into the submucosal layer at a 30° angle, creating a barrier between the haemorrhoid and the muscle layer.
3. Insert the tip of the HPR45i probe into the haemorrhoid centrally, towards the feeding vessel. Always work above the dentate line.
4. Lift the tip of the probe to create separation from the muscle layer and press the footswitch to apply RF energy. Watch for tissue discolouration and haemorrhoid retraction as indicators of successful thermocoagulation. For larger piles, repeat the process 2-3 times, moving the tip around like a fan.
5. Withdraw the probe and clean if necessary. If necessary, apply energy to the haemorrhoid surface.
6. Cool and clean the treated area using cold, wet gauze. Withdraw the anoscope and reposition for the next pile.
Clinical studies
A. Laurain, D. Bouchard, J.-M. Rouillon, P. Petit, A. Liddo, B. Vinson Bonnet, A. Venara, J.-M. Didelot, G. Bonnaud, A. Senéjoux, T. Higuero, P. Delasalle, A.-L. Tarrerias, F. Devulder, A. Castinel, C. Thomas, H. Pillant Le Moult, C. Favreau-Weltzer & L. Abramowitz; Techniques in Coloproctology 2 April 2023
Prokopis Christodoulou, Ioannis Baloyiannis, Konstantinos Perivoliotis, Dimitrios Symeonidis & George Tzovaras Techniques in Coloproctology 13 November 2022
Jean-Michel Didelot, Benjamin Raux, Romain Didelot, Franz Rudler, Aurelien Mulliez, Anthony Buisson, Armando Abergel, Pierre Blanc; Annals of Coloproctology 11 October 2022
Dr. S. Tolksdorf, D. Tübergen, C. Vivaldi, M. Pisek, F. Klug, M. Kemmerling, H. Schäfer; Techniques in Coloproctology March 2022
Sarah Hassan, Daniel McGrath, Richard Barnes, Simon Middleton; Annals of Coloproctology 18 August 2021
Initial experience of radiofrequency ablation for the treatment of advanced haemorrhoidal disease
Jignesh Ashwin Gandhi, Pravin Hanumant Shinde, Amay Banker, Sadashiv N. Chaudhari; Gastroenterology Review 2021
F. Drissi, M.-H. Jean, E. Abet; Journal de Chirurgie Viscérale 2021
J.-M. Didelot, R. Didelot; International Journal of Colorectal Disease 2020
M.M.R. Eddama, M. Everson, S. Renshaw, T. Taj, R. Boulton, J. Crosbie, C. Richard Cohen; Techniques in Coloproctology 24 July 2019
H. Schäfer, S. Tolksdorf, C. Vivaldi; Coloproctology 2018
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Alternative treatments
Surface ablation with the Sphera ball probe
An alternative for early-stage (Grade I-II) internal haemorrhoids is the Sphera ball probe, which utilises the same basic radiofrequency technology but focusses it on the exterior of the haemorrhoid (as opposed to the Rafaelo® needle probe, which is designed to puncture the haemorrhoid).