Efficacy and Safety of Propionibacterium Extract Gel Versus 0.4% Glyceryl Trinitrate Ointment in the Treatment of Chronic Anal Fissure: a Randomised Controlled Trial

Last updated: November 13, 2022
Sponsor: Treviso Regional Hospital
Overall Status: Completed

Phase

4

Condition

Bowel Dysfunction

Rectal Disorders

Treatment

N/A

Clinical Study ID

NCT05616455
EMOR
  • All Genders

Study Summary

The study compares the efficacy and safety of a Propionibacterium extract gel with 0.4% glyceryl trinitrate ointment in the treatment of chronic anal fissure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consecutive patients diagnosed with chronic anal fissure aged between 18 and 75 years

Exclusion

Exclusion Criteria:

  • Fecal incontinence
  • Inflammatory bowel disease
  • Previous history of anal surgery
  • Previous or concomitant treatment for anal fissure, sexually transmitted disease,cancer, immune-suppressive treatment
  • Current pregnancy or breastfeeding
  • Known allergy to one of the agents contained into the evaluating drugs

Study Design

Total Participants: 120
Study Start date:
October 01, 2021
Estimated Completion Date:
May 31, 2022

Study Description

Patients were randomly allocated to a PeG or GTN group and medication was taken every 12 hours for 40 days. Primary outcome was the success rate as measured by a decrease in the REALISE score at 10, 20 and 40 days after starting either treatment. The secondary out-comes were the healing rate, the partial or complete resolution of itching and burning, the rate of complications and adverse events, patients' quality of life and satisfaction at the same time points.

Connect with a study center

  • Regional Hospital Treviso

    Treviso, 31100
    Italy

    Site Not Available

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