Polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease in patients with bleeding disorders: a multicenter, prospective, cohort study

Abstract

Background The management of hemorrhoidal disease (HD) in patients with bleeding disorders (BD) is challenging. Polidocanol foam sclerotherapy (PFS) is associated with a low rate of bleeding complications. The aim of this study was to compare the efficacy and safety of PFS in the treatment of HD in patients with and without BD. Methods This prospective, multicenter, cohort study enrolled patients with (group B) and without (group A) BD, with symptomatic internal HD grades I–III over an 18-month period. All patients were treated with PFS. Patients with congenital BD did not undergo prior replacement therapy and those with acquired BD due to antithrombotic drugs, did not discontinue therapy. Efficacy outcomes included therapeutic success and HD recurrence during a 1-year follow-up period. To evaluate safety the complications related to PFS were recorded. Results We included 228 patients (group A: 155, group B: 73; male/female: 114/114; mean age: 59.4 ± 15.9 years). The baseline hemorrhoidal disease bleeding grade ( p < 0.001 ) and Sodergren hemorrhoidal symptom severity score ( p = 0.019 ) were higher for group B. The overall therapeutic success rate was 93.4% with an average number of sessions of 1.51 ± 0.74, significantly higher for group B (1.68 ± 0.86 vs 1.43 ± 0.65, p = 0.013 ). Complications occurred in 11.4% of the patients, with bleeding reported in 4.8%. The majority of complications were mild (96.2%). No significant differences between the two groups were observed for therapeutic success, recurrence, or complication rate. Conclusions Patients with BD may have more symptomatic HD at baseline. Even so, PSF showed similar effectiveness and safety in patients with BD compared to patients without BD. Supplementary Information The online version contains supplementary material available at 10.1007/s10151-022-02600-5.

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].…”

“…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.…”

“…Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/codi.16380 by CochraneItalia, Wiley Online Library on[10/11/2022]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License some studies have reported a similar technique to that used in this study[9][10][11], Salgueiro and colleagues[6,8] have published two recent studies where the foam was obtained by mixing 4 ml of liquid polidocanol 3% with 16 ml of air using Tessari's method. The maximum dose per session was 20 ml contrary to what was suggested in our previous experience in which we recommend not to exceed 8-10 ml in total (2-3 cc per pile).…”

The comeback of hemorrhoidal sclerotherapy?

“…Finally, hemorrhoidal disease recurred in 9.4% of patients during the 12 month follow-up period. Again, this rate was no higher for patients with bleeding disorders [17].…”

“…A recent randomized controlled trial even showed the injection of this foam to be more effective than rubber band ligation [15]. The renewed interest in this technique is well illustrated by the concomitant publication of two articles on the evaluation of polidocanol foam in this issue of Techniques in Coloproctology [16,17].…”