RAFAELO: A NEW SOLUTION FOR AN OLD PROBLEM RADIOFREQUENCY ABLATION APPLIED TO HAEMORRHOIDAL DISEASE
Sophie Williams*, Monica Ortenzi, Amyn Haji
Endoscopy, King's College Hospital, London, United Kingdom
Introduction
Haemorrhoidal disease is a very common condition worldwide; numerous invasive options for the treatment of haemorrhoids have been proposed over the last century. Radiofrequency ablation is a thermal-based technology used to occlude veins through the direct insertion of a catheter into a haemorrhoidal vein. The principles of this treatment were first described as a treatment for varicose veins; this less invasive method is comparable to its surgical alternative in terms of efficacy. The Rafaelo© system may represent a novel application for an old solution to treat haemorrhoidal disease. The aim of this paper is to analyse the first outcomes of this therapeutic approach.
Methods
Between May 2017 and January 2018 demographics, clinical features, variables related to the procedure, postoperative course, and follow-up of consecutive patients treated with the Rafaelo© technique were recorded. All patients were discharged within the first post-procedural hour, with or without post-procedural defaecation. Post-procedural analgesic protocol consisted of oral nonsteroidal anti-inflammatory medication for 72 hours following the procedure and extended depending on patient need; any additional analgesia use was recorded. Patients were evaluated with clinical examination and proctoscopy at 4 weeks, 6 and 8 weeks from the procedure, and annually. Post-procedural pain and patient satisfaction was recorded on the 1st, 2nd, 7th and 14th day after the Rafaelo® procedure, with use of a linear analog scale from 0 to 10 (0 no pain; 10 unbearable pain).
Results
86 patients were treated in this time period (55 males, 63.9%, 31 females, 36%). The median age was 48.9 ± 5.1 years. No patients received other proctological intervention in addition to Rafaelo©. The average energy delivered was 1998.1 (± 1579.8). The median operative time was 77.4 seconds (± 62.5). There was a correlation between the time needed for the procedure and energy delivered and the degree of haemorrhoids. A positive correlation was noticed even before the amount of energy delivered and the type of anaesthesia. No suture ligations were required. The most common symptoms after the procedure were pain (4; 4.6 %), bleeding (1; 1.2 %) and itching (1; 1.2 %. In the first week symptoms were: pain (3; 3.5 %), bleeding (2; 2.4 %), prolapse (2; 2.4 %), mucus discharge (2; 2.4 %), itching (2; 2.4 %). No symptoms were observed 2 weeks after the procedure. Five patients required a second procedure within 3 months.
Conclusions
Based on our experience, we conclude that the Rafaelo© procedure could represent a valuable alternative to surgery due to it being minimally invasive, fast, with a low pain risk, offering a safe and efficient discharge for patients post-procedure. Further data are needed to evaluate the long-term results and to confirm is comparability or superiority to surgery in terms of efficacy.
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