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

Digennaro R, Pecorella G, La Manna S, Alderisio A, Alderisio A, De Pascalis B, Pennisi D, Santangelo G, Pezzolla F, Racalbuto A, Serra G, Pulvirenti D'Urso A, Altomare DF - Tech Coloproctol (2015)

Bottom Line: 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.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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Emergency and Organ Transplantation, University of Bari, Piazza G Cesare, 11, 70124, Bari, Italy.

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.

No MeSH data available.


Related in: MedlinePlus

Outcome of conservative treatment with Levorag® Emulgel in acute or chronic anal fissures (p < 0.001)
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Fig4: Outcome of conservative treatment with Levorag® Emulgel in acute or chronic anal fissures (p < 0.001)

Mentions: No difference in the healing rate was observed according to the sex of the patients (p = 0.58) or the site of the fissure, (p = 0.77) while, as expected, acute fissure were more likely to heal than chronic fissures (89.4 and 62.8 %, respectively, p < 0.001) (Fig. 4).Fig. 4


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

Digennaro R, Pecorella G, La Manna S, Alderisio A, Alderisio A, De Pascalis B, Pennisi D, Santangelo G, Pezzolla F, Racalbuto A, Serra G, Pulvirenti D'Urso A, Altomare DF - Tech Coloproctol (2015)

Outcome of conservative treatment with Levorag® Emulgel in acute or chronic anal fissures (p < 0.001)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4555206&req=5

Fig4: Outcome of conservative treatment with Levorag® Emulgel in acute or chronic anal fissures (p < 0.001)
Mentions: No difference in the healing rate was observed according to the sex of the patients (p = 0.58) or the site of the fissure, (p = 0.77) while, as expected, acute fissure were more likely to heal than chronic fissures (89.4 and 62.8 %, respectively, p < 0.001) (Fig. 4).Fig. 4

Bottom Line: 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.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.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.

View Article: PubMed Central - PubMed

Affiliation: Department of Emergency and Organ Transplantation, University of Bari, Piazza G Cesare, 11, 70124, Bari, Italy.

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.

No MeSH data available.


Related in: MedlinePlus