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

Not Applicable

• Conditions: Fissure in Ano
• Interventions: Device: Fitostimoline proctogel; Device: Fitostimoline proctogel + muscle relaxant

• Registration Number: NCT04714684
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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

Study Timeline

• Study First Submitted: 2020-11-27
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-15
• Last Update Submitted: 2021-01-15
• Study First Posted: 2021-01-19
• Last Update Posted: 2021-01-19
• Study Start: 2021-02-10
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• None previous therapies for anal fissure
• Symptomatic anal fistula
• Signing of informed consent
• age >18 years old

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Exclusion Criteria

• Patients unable to complete the questionnaire and with a legal guardian.
• Patients with concomitant abscess/fistula
• Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fitostimoline proctogel + muscle relaxants	Fitostimoline proctogel	-
fitostimoline proctogel	Fitostimoline proctogel	-
muscle relaxants	Fitostimoline proctogel	-
fitostimoline proctogel + muscle relaxants	Fitostimoline proctogel + muscle relaxant	-
muscle relaxants	Fitostimoline proctogel + muscle relaxant	-
fitostimoline proctogel	Fitostimoline proctogel + muscle relaxant	-

Primary Outcome Measures

Name	Time	Method
need of invasive treatment	30 days	Anal dilatation, lateral internal sphincterotomy
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)

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