Anal Fissure Chronic, Anal Fissure
Conditions
Brief 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.
Detailed 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.
Interventions
Application of the gel every 12 hours for 40 days
DRUGPropionibacterium Acnes
Application of the gel every 12 hours for 40 days
Sponsors
Treviso Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| REALISE score | 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
| Measure | Time frame | Description |
|---|---|---|
| Burning | From baseline to visit 3 (40 days after the start of the treatment) | Visual analogue scale (VAS) (minimum score = 0, maximum score = 10) |
| Itching | From baseline to visit 3 (40 days after the start of the treatment) | Visual analogue scale (VAS) (minimum score = 0, maximum score = 10) |
| Epithelialization | 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. |
| Physical and mental health | From baseline to visit 3 (40 days after the start of the treatment) | Short-Form 12 (SF-12) |
| Patients' satisfaction | 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) |
Countries
Italy
Outcome results
None listed