The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
- Conditions
- Fissure in Ano
- Registration Number
- NCT04714684
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- None previous therapies for anal fissure
- Symptomatic anal fistula
- Signing of informed consent
- age >18 years old
- Patients unable to complete the questionnaire and with a legal guardian.
- Patients with concomitant abscess/fistula
- Pregnant women
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method anal fissure healing 30 days no pain (NRS scale \< 1, where 0 is absence of pain and 10 is maximum pain), no bleeding