title: Prospective multicenter observational trial on the safety and efficacy of LEVORAG® Emulgel in the treatment of acute and chronic anal fissure.
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.
authors.affiliation: Department of Emergency and Organ Transplantation, University of Bari, Piazza G Cesare, 11, 70124, Bari, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Digennaro
authors.forename: G
authors.initials: G
authors.lastname: Pecorella
authors.forename: S
authors.initials: S
authors.lastname: La Manna
authors.forename: A
authors.initials: A
authors.lastname: Alderisio
authors.forename: A
authors.initials: A
authors.lastname: Alderisio
authors.forename: B
authors.initials: B
authors.lastname: De Pascalis
authors.forename: D
authors.initials: D
authors.lastname: Pennisi
authors.forename: G
authors.initials: G
authors.lastname: Santangelo
authors.forename: F
authors.initials: F
authors.lastname: Pezzolla
authors.forename: A
authors.initials: A
authors.lastname: Racalbuto
authors.forename: G
authors.initials: G
authors.lastname: Serra
authors.forename: A
authors.initials: A
authors.lastname: Pulvirenti D'Urso
authors.forename: D F
authors.initials: DF
authors.lastname: Altomare
mesh_terms: D000208:Acute Disease; D000328:Adult; D002908:Chronic Disease; D004334:Drug Administration Schedule; D004643:Emollients / Q000627:therapeutic use*; D005260:Female; D005401:Fissure in Ano / Q000188:drug therapy*; D005782:Gels / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D004643:Emollients; D005782:Gels