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NCT Number: NCT05616455

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

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.

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Key information

Conditions

Anal Fissure Chronic Anal Fissure Anus Diseases Digestive System Diseases Fissure in Ano Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Study type

Interventional

Phase

Phase 4

Primary location

Regional Hospital Treviso

Treviso, 31100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Propionibacterium Acnes

Drug

Application of the gel every 12 hours for 40 days

glyceryl trinitrate

Drug

Application of the gel every 12 hours for 40 days

Primary outcomes

  1. REALISE score

    Time frame: From baseline to visit 3 (40 days after the start of the treatment)

    REALISE (scoRing systEm for AnaL fIsSurE), was used to assess pain (minimum score = 0, maximum score = 10)

Secondary outcomes

  1. Burning

    Time frame: From baseline to visit 3 (40 days after the start of the treatment)

    Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)

  2. Itching

    Time frame: From baseline to visit 3 (40 days after the start of the treatment)

    Visual analogue scale (VAS) (minimum score = 0, maximum score = 10)

  3. Epithelialization

    Time frame: From baseline to visit 3 (40 days after the start of the treatment)

    The degree of epithelialization of the fissure was determined at each visit and stratified using 3 levels (1 to 3) corresponding to <50%, >50% of healing or complete healing, respectively.

  4. Physical and mental health

    Time frame: From baseline to visit 3 (40 days after the start of the treatment)

    Short-Form 12 (SF-12)

  5. Physical and mental health

    Time frame: At visit 3 (40 days after the start of the treatment)

    SF-36 - Physical component score (PCS)

  6. Physical and mental health

    Time frame: At visit 3 (40 days after the start of the treatment)

    SF-36 - Mental component score (MCS)

  7. Patients' satisfaction

    Time frame: At visit 3 (40 days after the start of the treatment)

    VAS (1 = unsatisfied; 2 = neutral; 3 = quite satisfied; 4 = very satisfied; 5 = extremely satisfied)

Sponsors and collaborators

Lead sponsor

Treviso Regional Hospital

Network

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 15, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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