xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05993793</url>
    </required_header>
    <id_info>
      <org_study_id>53623621.0.0000.5544</org_study_id>
      <nct_id>NCT05993793</nct_id>
    </id_info>
    <brief_title>Use of Fototherapy in the Treatment of Fissure in Ano</brief_title>
    <official_title>Use of Fototherapy in the Treatment of Fissura in Ano</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centro de Atenção ao Assoalho Pélvico</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centro de Atenção ao Assoalho Pélvico</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The eligible population consisted of individuals with anal fissure awaiting surgical&#xD;
        intervention. Individuals aged 18 years or older were included, diagnosed with anal fissure&#xD;
        and who voluntarily agreed to participate in the research. Those who had some pelvic&#xD;
        inflammation and who had already undergone a surgical procedure and had recurrence were&#xD;
        excluded from the studyThe selected individuals underwent a standardized anamnesis of the&#xD;
        service, answered questionnaires on symptoms of intestinal constipation (Rome IV Criteria and&#xD;
        the Bristol Scale), underwent a physical evaluation by a trained professional, and then began&#xD;
        the application of the research protocol. The Antares brand Laser device was used for 3&#xD;
        sessions with an interval of 24 hours. The Visual Analogue Scale (VAS) was used before&#xD;
        starting treatment, after the first and second sessions, and 1 week after the third session.&#xD;
        In addition, at the end of the treatment, the closure, or not, of the lesion was verified,&#xD;
        and the questionnaires performed prior to phototherapy were reapplied. The VAS assesses the&#xD;
        patient's level of pain, which can be divided into mild pain (1-2), moderate pain (3-7), and&#xD;
        severe pain (8-10). The Bristol Scale is based on the identification of the patient's&#xD;
        consistency of stools, while types 1-2 correspond to constipation, 3-4 indicate normal&#xD;
        intestinal rhythm, 5 indicate lack of fiber, and 6-7 correspond to diarrhea.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2022</start_date>
    <completion_date type="Actual">December 20, 2022</completion_date>
    <primary_completion_date type="Actual">August 30, 2022</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complete closure of the fissure</measure>
      <time_frame>15 days</time_frame>
      <description>It is estimated that the fototherapy will close completely the fissure in patients with fissure in ano.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">10</enrollment>
    <condition>Fissure in Ano</condition>
    <arm_group>
      <arm_group_label>Fototherapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Fototherapy</intervention_name>
      <description>The Antares brand Laser device was used for 3 sessions with an interval of 24 hours. The Visual Analogue Scale (VAS) was used before starting treatment, after the first and second sessions, and 1 week after the third session. In addition, at the end of the treatment, the closure, or not, of the lesion was verified, and the questionnaires performed prior to phototherapy were reapplied. The VAS assesses the patient's level of pain, which can be divided into mild pain (1-2), moderate pain (3-7), and severe pain (8-10). The Bristol Scale is based on the identification of the patient's consistency of stools, while types 1-2 correspond to constipation, 3-4 indicate normal intestinal rhythm, 5 indicate lack of fiber, and 6-7 correspond to diarrhea</description>
      <arm_group_label>Fototherapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  individuals with the diagnosis of anal fissure that accepted to participate as&#xD;
               volunteers in the clinical trial&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  individuals with pelvic inflammation&#xD;
  &#xD;
            -  individuals who have been through surgical procedures&#xD;
  &#xD;
            -  individuals who have relapse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Instituto Patrícia Lordelo</name>
        <address>
          <city>Salvador</city>
          <state>BA</state>
          <zip>41825-000</zip>
          <country>Brazil</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>fissure</keyword>
    <keyword>ano</keyword>
    <keyword>phototherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fissure in Ano</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05993793
  org study id: 53623621.0.0000.5544
  nct id: NCT05993793
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The eligible population consisted of individuals with anal fissure awaiting surgical
        intervention. Individuals aged 18 years or older were included, diagnosed with anal fissure
        and who voluntarily agreed to participate in the research. Those who had some pelvic
        inflammation and who had already undergone a surgical procedure and had recurrence were
        excluded from the studyThe selected individuals underwent a standardized anamnesis of the
        service, answered questionnaires on symptoms of intestinal constipation (Rome IV Criteria and
        the Bristol Scale), underwent a physical evaluation by a trained professional, and then began
        the application of the research protocol. The Antares brand Laser device was used for 3
        sessions with an interval of 24 hours. The Visual Analogue Scale (VAS) was used before
        starting treatment, after the first and second sessions, and 1 week after the third session.
        In addition, at the end of the treatment, the closure, or not, of the lesion was verified,
        and the questionnaires performed prior to phototherapy were reapplied. The VAS assesses the
        patient's level of pain, which can be divided into mild pain (1-2), moderate pain (3-7), and
        severe pain (8-10). The Bristol Scale is based on the identification of the patient's
        consistency of stools, while types 1-2 correspond to constipation, 3-4 indicate normal
        intestinal rhythm, 5 indicate lack of fiber, and 6-7 correspond to diarrhea.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete closure of the fissure
  time frame: 15 days
  description: It is estimated that the fototherapy will close completely the fissure in patients with fissure in ano.
  arm group label: Fototherapy
  arm group type: Experimental
  intervention type: Device
  intervention name: Fototherapy
  description: The Antares brand Laser device was used for 3 sessions with an interval of 24 hours. The Visual Analogue Scale (VAS) was used before starting treatment, after the first and second sessions, and 1 week after the third session. In addition, at the end of the treatment, the closure, or not, of the lesion was verified, and the questionnaires performed prior to phototherapy were reapplied. The VAS assesses the patient's level of pain, which can be divided into mild pain (1-2), moderate pain (3-7), and severe pain (8-10). The Bristol Scale is based on the identification of the patient's consistency of stools, while types 1-2 correspond to constipation, 3-4 indicate normal intestinal rhythm, 5 indicate lack of fiber, and 6-7 correspond to diarrhea
  arm group label: Fototherapy
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Brazil
  responsible party type: Sponsor
  mesh term: Fissure in Ano