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

Fissure in Ano Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04714684
• Other study ID #: FITOSTIMOLINE
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: February 10, 2022

Study information

• Verified date: January 2021
• Source: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fissure in Ano

Intervention

Device:
• Fitostimoline proctogel
Medical device for topical use for the treatment of fissures
• Fitostimoline proctogel + muscle relaxant
medical device for topical use for the treatment of fissures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	need of invasive treatment	Anal dilatation, lateral internal sphincterotomy	30 days
Secondary	anal fissure healing	no pain (NRS scale < 1, where 0 is absence of pain and 10 is maximum pain), no bleeding	30 days