Research
Print page Print page
Switch language
Bispebjerg Hospital - a part of Copenhagen University Hospital
Published

Treatment of chronic anal fissure: a feasibility study on Levorag® Emulgel versus Diltiazem gel 2

Research output: Contribution to journalJournal articleResearchpeer-review

  1. The effect of gender on early colonic anastomotic wound healing

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. One decade of rectal prolapse surgery: a national study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Type of incision does not predict abdominal wall outcome after emergency surgery for colonic anastomotic leakage

    Research output: Contribution to journalJournal articleResearchpeer-review

  1. The Incidence and Disease Course of Perianal Crohn's Disease: A Danish Nationwide Cohort Study, 1997-2015

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Ikke alt er hæmorroider. Om diagnostik og behandling af akutte anallidelser i almen praksis.

    Research output: Contribution to journalJournal articleCommunication

  3. Behandling af analabscesser

    Research output: Contribution to journalJournal articleResearchpeer-review

View graph of relations

PURPOSE: To compare the standard treatment, diltiazem gel 2%, with Levorag® Emulgel for chronic anal fissures.

METHODS: This was a single-blinded, randomised, controlled, clinical trial with a non-inferiority design. Patients with a chronic anal fissure were randomised to treatment with diltiazem or Levorag® Emulgel twice daily for 8 weeks. Primary endpoint was complete healing of the anal fissure after 12 weeks. Secondary endpoints included incidence of adverse events and efficacy on pain relief.

RESULTS: In total, 55 patients were included. Inclusion was terminated prematurely due to a slow inclusion rate. Complete fissure healing at 12 weeks follow-up was overall achieved in 31 of 55 (56%) patients, 18 of 29 (62%) in the diltiazem group compared with 13 of 26 (50%) in the Levorag® Emulgel group (P = 0.424). Pain relief was significantly better at day seven in patients treated with diltiazem (P = 0.040) compared with Levorag® Emulgel, whereas there were no differences in early (3 days) or late (12 weeks) pain relief. Three patients (10.3%) developed severe perianal exanthema during diltiazem treatment, whereas no side effects were observed in the Levorag® Emulgel group.

CONCLUSION: The study demonstrated statistical non-inferiority of Levorag® Emulgel compared with diltiazem in the treatment of chronic anal fissure. Diltiazem resulted in a more prompt pain relief and also in a substantial number of local allergic reactions. Levorag® Emulgel may therefore be an alternative in these patients.

TRIAL REGISTRATION: Clinicaltrials.gov no. NCT02158013.

Original languageEnglish
JournalInternational Journal of Colorectal Disease
Volume35
Issue number4
Pages (from-to)615-621
Number of pages7
ISSN0179-1958
DOIs
Publication statusPublished - Apr 2020

    Research areas

  • Adult, Chronic Disease, Diltiazem/adverse effects, Drug Combinations, Feasibility Studies, Female, Fissure in Ano/complications, Humans, Male, Pain/drug therapy, Plant Extracts/adverse effects, Wound Healing, Young Adult, beta-Glucans/adverse effects

ID: 62415725