Prospective multicenter observational trial on the safety and efficacy of LEVORAG® Emulgel in the treatment of acute and chronic anal fissure

Autor: R. Digennaro, G. Pecorella, S. La Manna, A. Alderisio, B. De Pascalis, D. Pennisi, G. Santangelo, F. Pezzolla, A. Racalbuto, G. Serra, A. Pulvirenti D’Urso, D. F. Altomare
Jazyk: angličtina
Rok vydání: 2015
Předmět:
Zdroj: Techniques in Coloproctology
ISSN: 1128-045X
1123-6337
Popis: Background Anal fissure (AF) is a common cause of anal pain with a tendency not to heal spontaneously because of ischemia of the anoderm caused by sphincter spasm. Lateral internal sphincterotomy, while very effective, can cause fecal incontinence and chemical sphincterotomy by application of cream may have discouraging side effects and/or low efficacy. The aim of this prospective multicenter study was to evaluate the safety and effectiveness of a new medical treatment based on Emulgel cream, with emollient, soothing and protective agents, on AF healing. Methods Consecutive patients with AF treated in nine coloproctology units during 6 months entered the study on topical treatment with Levorag® Emulgel (THD S.p.A Correggio (RE), Italy). Before treatment, they had a proctologic examination and pain was measured using a visual analog scale. THD Levorag® Emulgel was applied every 12 h for 40 days. Monitoring was scheduled at 10, 20 and 40 days. At time 0 and at the end of treatment, patients underwent anorectal manometry, if possible. Results Two hundred eighty-four AF patients were recruited (171 acute fissures). Complete healing was achieved in 47.9 % of the cases, an improvement in 31.0 % (global efficacy 78.9 %). In patients with acute fissure, the rate of efficacy was 89.4 % (complete healing: 64.3 %, improvement: 25.1 %), in those with chronic fissure the rate of efficacy was 62.8 % (complete healing: 23 %, improvement: 39.8 %), p
Databáze: OpenAIRE