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

Primary Purpose

Fissure in Ano

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fitostimoline proctogel
Fitostimoline proctogel + muscle relaxant
Sponsored by
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fissure in Ano

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    fitostimoline proctogel

    fitostimoline proctogel + muscle relaxants

    muscle relaxants

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)
    need of invasive treatment
    Anal dilatation, lateral internal sphincterotomy

    Secondary Outcome Measures

    anal fissure healing
    no pain (NRS scale < 1, where 0 is absence of pain and 10 is maximum pain), no bleeding

    Full Information

    First Posted
    November 27, 2020
    Last Updated
    January 15, 2021
    Sponsor
    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04714684
    Brief Title
    The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
    Official Title
    The Role of Fitostimoline Proctogel in Symptoms Relief and Healing in Patients Affected by Anal Fissure
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 10, 2021 (Anticipated)
    Primary Completion Date
    February 10, 2022 (Anticipated)
    Study Completion Date
    February 10, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fissure in Ano

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    fitostimoline proctogel
    Arm Type
    Experimental
    Arm Title
    fitostimoline proctogel + muscle relaxants
    Arm Type
    Experimental
    Arm Title
    muscle relaxants
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Fitostimoline proctogel
    Other Intervention Name(s)
    muscle relaxant
    Intervention Description
    Medical device for topical use for the treatment of fissures
    Intervention Type
    Device
    Intervention Name(s)
    Fitostimoline proctogel + muscle relaxant
    Intervention Description
    medical device for topical use for the treatment of fissures
    Primary Outcome Measure Information:
    Title
    control of anal fissure symptoms
    Description
    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)
    Time Frame
    30 days
    Title
    need of invasive treatment
    Description
    Anal dilatation, lateral internal sphincterotomy
    Time Frame
    30 days
    Secondary Outcome Measure Information:
    Title
    anal fissure healing
    Description
    no pain (NRS scale < 1, where 0 is absence of pain and 10 is maximum pain), no bleeding
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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