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Observational Study
. 2015 May;19(5):287-92.
doi: 10.1007/s10151-015-1289-2. Epub 2015 Mar 15.

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

R Digennaro  1 , G Pecorella, S La Manna, A Alderisio, A Alderisio Jr, B De Pascalis, D Pennisi, G Santangelo, F Pezzolla, A Racalbuto, G Serra, A Pulvirenti D'Urso, D F Altomare
Affiliations
Observational Study

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

R Digennaro et al. Tech Coloproctol. 2015 May.

Abstract

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 < 0.001. Pain and resting anal pressure decreased significantly after treatment.

Conclusions: Treatment with THD Levorag(®) Emulgel proved to be effective for the reepithelization of AF and the reduction of pain in the short term in about 80 % of patients.

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Figures

Fig. 1
Fig. 1
Flow chart showing the outcome of the trial
Fig. 2
Fig. 2
a Anal manometry before and after 40 days of treatment in patients with acute anal fissures. b Anal manometry before and after 40 days of treatment in patients with chronic anal fissures
Fig. 3
Fig. 3
Pain score changes over time, in patients with acute and chronic anal fissure (p < 0.001, ANOVA)
Fig. 4
Fig. 4
Outcome of conservative treatment with Levorag® Emulgel in acute or chronic anal fissures (p < 0.001)
See this image and copyright information in PMC

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