The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure

Conditions
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Fissure in Ano

Intervention / Treatment
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* Device: Fitostimoline proctogel
* Device: Fitostimoline proctogel + muscle relaxant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fitostimoline proctogel<br> | Device: Fitostimoline proctogel<br>* Medical device for topical use for the treatment of fissures<br>* Other names: muscle relaxant;Device: Fitostimoline proctogel + muscle relaxant<br>* medical device for topical use for the treatment of fissures<br>|
| Experimental: fitostimoline proctogel + muscle relaxants<br> | Device: Fitostimoline proctogel<br>* Medical device for topical use for the treatment of fissures<br>* Other names: muscle relaxant;Device: Fitostimoline proctogel + muscle relaxant<br>* medical device for topical use for the treatment of fissures<br>|
| Experimental: muscle relaxants<br> | Device: Fitostimoline proctogel<br>* Medical device for topical use for the treatment of fissures<br>* Other names: muscle relaxant;Device: Fitostimoline proctogel + muscle relaxant<br>* medical device for topical use for the treatment of fissures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |