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
The strengths of the Rafaelo procedure are, on the one hand, its very low morbidity, i.e. it is a low-pain technique in most cases, with the use of level 2 painkillers for two or three days, after which patients very quickly stop taking their painkillers. So the pain is usually very minor and quite short compared to the Milligan Morgan haemorrhoidectomy. The effectiveness seems to be true, both in the French evaluation and in my personal experience, as we have less than 5% surgical recurrence per year. The second aspect of this technique, which is also very, very interesting and puts it far ahead of the other minimally invasive techniques, is its simplicity and speed. Speed is really a big advantage of the technique because the administration of the product, let’s say, happens in two minutes, two and a half minutes, and the whole procedure takes a maximum of 10 minutes.
Dr. Dominique Bouchard, MD Proctologist , Maison de Santé Protestante Bagatelle, Talence, France
The Rafaelo technique completes the panel of operative techniques in relation to haemorrhoidal pathology. I think that we need to know them all, and have them all available. It’s a tool that we need at our disposal to be able to guarantee everyone the right treatment.
Dr. Antonella Liddo, Visceral and digestive surgeon, Hôpital de la Victoire, Tourcoing, France
This minimally invasive treatment fills the gap between ligature treatment and surgical resection for haemorrhoidal disease. It is excellently suited to outpatient treatment in the proctological practice. I am particularly enthusiastic about the very low post-operative pain after Rafaelo therapy.
Dr. Daniel Sterzing, Specialist in general surgery, visceral surgeon, Proktologisches Zentrum Berlin, Germany
I have good feedback with patients who have little or no pain and can return to work within 3 to 5 days.
Dr. Yann Redon, visceral and digestive surgeon, Saint-Nazaire, France
I have been working with Rafaelo for four years. Minimally invasive, with few complications and highly effective – from my point of view a highly useful addition in the treatment of haemorrhoids of all stages.
Priv.-Doz. Dr. med. Robert Eisele, Doctor, specialist in general surgery, visceral surgeon, Oranienburg, Germany
Treating patients with third-degree haemorrhoids with little pain and under local anaesthetic in the daily practice routine – the Rafaelo procedure now offers the possibility of a safe and reliable method!
Dr. Christian Lorz, MVZ for Surgery and Orthopaedics, Vincentinum, Augsburg, Germany
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.
What can patients expect in the long term from radiofrequency thermocoagulation of hemorrhoids on bleeding, prolapse, quality of life, and recurrence: “no pain, no gain” or “no pain but a gain”?
Jean-Michel Didelot, Benjamin Raux, Romain Didelot, Franz Rudler, Aurelien Mulliez, Anthony Buisson, Armando Abergel, Pierre Blanc; Annals of Coloproctology; 11 October 2022
Early and midterm results of radiofrequency ablation (Rafaelo® procedure) for third-degree haemorrhoids: a prospective, two-centre study;
Dr. S. Tolksdorf, D. Tübergen, C. Vivaldi, M. Pisek, F. Klug, M. Kemmerling, H. Schäfer; Techniques in Coloproctology, March 2022
Radiofrequency thermocoagulation of haemorrhoidal bundles, an alternative technique for the management of internal haemorrhoids;
J.-M. Didelot, R. Didelot; International Journal of Colorectal Disease 2020
Radiofrequency ablation for the treatment of haemorrhoidal disease: a minimally invasive and effective treatment modality;
M.M.R. Eddama, M. Everson, S. Renshaw, T. Taj, R. Boulton, J. Crosbie, C. Richard Cohen; Techniques in Coloproctology 24 July 2019
Radiofrequency ablation (Rafaelo® procedure) for the treatment of grade III haemorrhoids, technique and first clinical results;
H. Schäfer, S. Tolksdorf, C. Vivaldi; Coloproctology 2018
Experience Rafaelo for yourself
Share this treatment
Choose between the HPR45i needle probe for pile insertion or the Sphera ball probe for surface-only coagulation.
Presets for haemorrhoid and anal fistula procedures make it ideal for proctological clinics.
Haemorrhoid rubber band ligation
Rafaelo® is suitable for treating Grade II, III, or early IV internal haemorrhoids.
For patients with Grade I and II internal haemorrhoids, we also offer the Pilex rubber-band ligator, an ergonomic one-handed tool that comes pre-loaded with four ligation bands.
Surface ablation with the Sphera ball probe
Another 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).