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Clinical Trials/NCT04714684
NCT04714684UnknownNot Applicable

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

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia0 sites100 target enrollmentStarted: February 10, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
100
Primary Endpoint
need of invasive treatment

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

need of invasive treatment

Time Frame: 30 days

Anal dilatation, lateral internal sphincterotomy

control of anal fissure symptoms

Time Frame: 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 Outcomes

  • anal fissure healing(30 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gian Luca Baiocchi

Prof.

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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