A Multicentre, Open-label, Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease

Detailed Summary

Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of three mechanisms that might underlie haemorrhoidal development - the varicose vein theory, the vascular hyperplasia theory and the sliding anal-lining theory, the exact pathophysiology of symptomatic hemorrhoid disease is poorly understood. HD seems to be the most common cause for rectal bleeding, or hematochezia, and the second most frequent cause for severe rectorrhagia after diverticulitis. The blood is bright red and coats the stool at the end of defection. Other symptoms include pain, mucous discharge, itching or the sensation of tissue prolapse. The most widely accepted classification is the Goligher classification: * Grade I: hemorrhoids bleed but do not prolapse out of the anal canal; * Grade II: hemorrhoidal cushions prolapse outside of the anal canal on straining or during bowel movements, but reduce spontaneously; * Grade III: hemorrhoidal cushions prolapse outside the anal canal on straining and require manual reduction; * Grade IV: hemorrhoidal prolapse is irreducible even with manipulation

Study Details

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Interventions