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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
Medical device for topical use for the treatment of fissures
medical device for topical use for the treatment of fissures
control of anal fissure symptoms
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)
Time frame: 30 days
need of invasive treatment
Anal dilatation, lateral internal sphincterotomy
Time frame: 30 days
anal fissure healing
no pain (NRS scale \< 1, where 0 is absence of pain and 10 is maximum pain), no bleeding
Time frame: 30 days
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