The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
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
Gian Luca Baiocchi
Prof.
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia