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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fitostimoline proctogel | Experimental |
| |
| fitostimoline proctogel + muscle relaxants | Experimental |
| |
| muscle relaxants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitostimoline proctogel | Device | Medical device for topical use for the treatment of fissures |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 days |
| need of invasive treatment | Anal dilatation, lateral internal sphincterotomy | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| anal fissure healing | no pain (NRS scale < 1, where 0 is absence of pain and 10 is maximum pain), no bleeding | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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|
| Fitostimoline proctogel + muscle relaxant | Device | medical device for topical use for the treatment of fissures |
|
| D004066 |
| Digestive System Diseases |