PURPOSE:Sclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease. METHODS: A total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session. RESULTS: In the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001). CONCLUSION: In the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.
RCT Entities:
PURPOSE: Sclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease. METHODS: A total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session. RESULTS: In the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001). CONCLUSION: In the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.
Authors: G Cocorullo; R Tutino; N Falco; L Licari; G Orlando; T Fontana; C Raspanti; G Salamone; G Scerrino; G Gallo; M Trompetto; G Gulotta Journal: G Chir Date: 2017 Jan-Feb
Authors: M Trompetto; G Clerico; G F Cocorullo; P Giordano; F Marino; J Martellucci; G Milito; M Mistrangelo; C Ratto Journal: Tech Coloproctol Date: 2015-09-24 Impact factor: 3.781
Authors: Paulo Salgueiro; Ana Célia Caetano; Ana Maria Oliveira; Bruno Rosa; Miguel Mascarenhas-Saraiva; Paula Ministro; Pedro Amaro; Rogério Godinho; Rosa Coelho; Rúben Gaio; Samuel Fernandes; Vítor Fernandes; Fernando Castro-Poças Journal: GE Port J Gastroenterol Date: 2019-09-05
Authors: G Gallo; J Martellucci; A Sturiale; G Clerico; G Milito; F Marino; G Cocorullo; P Giordano; M Mistrangelo; M Trompetto Journal: Tech Coloproctol Date: 2020-01-28 Impact factor: 3.781