Preliminary Results of the First 50 Patients Undergoing Sclerotherapy for II-Degree Hemorrhoidal Disease Using an Automated Device

Abstract

BackgroundSclerotherapy is defined as the injection of sclerosant agents causing fibrosis and scarring of the surrounding tissue. It is currently employed for the treatment of I-III degree hemorrhoidal disease (HD). The aim of this study is to investigate the use of a new automated device for the injection of 3% polidocanol foam.MethodsThis is an observational study including 50 patients who underwent a sclerotherapy procedure with 3% polidocanol foam for II-degree HD according to Goligher classification. Patients were evaluated through validated scores [Giamundo score, Hemorrhoidal Disease Symptom Score (HDSS), Short Health Scale (SHS-HD) and Vaizey score]. Follow-up was conducted until 3 months from the procedure.ResultsComplete resolution of bleeding was achieved in 72% and 78% of patients, respectively, at 1 week and after 3 months from the procedure. Forty eight percent of patients were symptom free after the last follow-up visit (HDSS = 0). No major surgical complications were reported. Three patients out of 36 successfully treated, recurred, and needed a second sclerotherapy injection, which was successful in 2 of them.ConclusionThese preliminary results of 3% polidocanol foam injection on 50 patients suggest the efficacy and reproducibility of the technique with this new device in the short-term follow-up.

Sclerotherapy with 3% polidocanol foam to treat second‐degree haemorrhoidal disease: Three‐year follow‐up of a multicentre, single arm, IDEAL phase 2b trial

“…The use of 3% polidocanol foam allowed a consistent reduction of local and systemic complications in comparison with previous sclerosing agents used in the past [21]. In fact, apart from one episode of acute prostatitis, described by Moser et al [10], and some of external thrombosis [7,9], there were no major complications or adverse events [6‐12].…”

“…Recently, we published the preliminary results, with 3 months of follow‐up and 78% success rate, of the first 50 patients undergoing sclerotherapy with the foam produced using an automated device that allowed us to maintain a liquid / gas ratio between 1: 5 and 1: 7 without the need to re‐emulsify the foam before each injection [12]. It will be necessary to treat large numbers with prolonged follow‐up but it seems that this is the way to go.…”

“…During the study period, 87% (143) patients underwent one sclerotherapy session and 12% (20) and 1% (2), respectively, underwent two and three sessions. Most of the redo-sclerotherapy was performed at T6 (12). Eight out of 12 of those patients have become successes while the other four underwent surgery.…”

“…Several studies have demonstrated its safety and efficacy in the last 10 years [6][7][8][9][10][11][12]. Among the main advantages that favoured its acceptance, especially during the COVID-19 pandemic where the availability of operating rooms had been reduced and elective procedures stopped or suspended [13], were the low cost, repeatability, almost total absence of complications as well as of procedural pain and discomfort for the patient even at the cost of a recurrence rate still not well defined.…”

Sclerotherapy for III- and IV-degree hemorrhoids: Results of a prospective study

“…Recently, Figueiredo et al ( 29 ) proposed sclerotherapy with 2% polidocanol foam in 243 patients with different grades of HDs. Despite several limitations as the average follow-up, there was no information about the sample size and the number of sessions used; certainly, it cannot be considered a reliable study, although it would be interesting to compare the results with 2% and 3% polidocanol foam in terms of bleeding recurrence, effectiveness, and postprocedure complications ( 30 ).…”