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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Status: Unknown

Conditions: Fissure in Ano

Treatments: Device: Fitostimoline proctogel + muscle relaxant; Device: Fitostimoline proctogel

Study type: Interventional

Funder types: Other

Identifiers

NCT04714684

FITOSTIMOLINE

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 3 patient groups

fitostimoline proctogel

Experimental group

Treatment:

Device: Fitostimoline proctogel

Device: Fitostimoline proctogel + muscle relaxant

fitostimoline proctogel + muscle relaxants

Experimental group

Treatment:

Device: Fitostimoline proctogel

Device: Fitostimoline proctogel + muscle relaxant

muscle relaxants

Experimental group

Treatment:

Device: Fitostimoline proctogel

Device: Fitostimoline proctogel + muscle relaxant