Fissure in Ano
Conditions
Brief summary
Evaluate the effectiveness of fitostimoline proctogel in the anal fissure healing and in the need for invasive interventions (primary endpoints) and in the healing of the fissure (secondary endpoint) using Fitostimoline in addition to or without other topical devices available on the market. Three groups will be established: one for the exclusive use of fitostimoline, the second for the use of fitostimoline in addition to one of the other topical devices already on the market and the third group only for the use of other topical therapies.
Interventions
DEVICEFitostimoline proctogel
Medical device for topical use for the treatment of fissures
DEVICEFitostimoline proctogel + muscle relaxant
medical device for topical use for the treatment of fissures
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* None previous therapies for anal fissure * Symptomatic anal fistula * Signing of informed consent * age \>18 years old
Exclusion criteria
* Patients unable to complete the questionnaire and with a legal guardian. * Patients with concomitant abscess/fistula * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| control of anal fissure symptoms | 30 days | pain relief (by using the NRS scale from 0 to 10 (0=absence of pain 10= maximum presence of pain) which should be lower than 3) |
| need of invasive treatment | 30 days | Anal dilatation, lateral internal sphincterotomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| anal fissure healing | 30 days | no pain (NRS scale \< 1, where 0 is absence of pain and 10 is maximum pain), no bleeding |
Outcome results
None listed