<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/NCT03780998</url>
  </required_header>
  <id_info>
    <org_study_id>yeditepe university</org_study_id>
    <nct_id>NCT03780998</nct_id>
  </id_info>
  <brief_title>Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases</brief_title>
  <official_title>Effects of Sodium Pentaborat Based Gel on Perianal Benign Diseases. Prospective Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SB Istanbul Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tabriz University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SB Istanbul Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      New produced and patented sodium pantaborat based gel will be use for treatment of benign&#xD;
      perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective randomised clinical trial planned. Older than 18 years old perianal benign&#xD;
      diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal&#xD;
      fistula) cases without malign tumour, cronic colorectal disases, and routine used of&#xD;
      vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any&#xD;
      malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases&#xD;
      were exclused of the study.&#xD;
&#xD;
      Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease&#xD;
      cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases&#xD;
      Group-5 (n:50): Uncomplicated, simple perianal fistula cases&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pain symtom differences</measure>
    <time_frame>six months</time_frame>
    <description>Pain Scale from level 1 to level 10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4)</measure>
    <time_frame>six months</time_frame>
    <description>Surgeon general physical examination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Closing of anal fissur line</measure>
    <time_frame>six months</time_frame>
    <description>Surgeon general physical examination. Fissur line is exist or not exist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lowering of leakage amount of perianal fistule</measure>
    <time_frame>six months</time_frame>
    <description>Three grade: lower, same, more</description>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Hemorrhoids</condition>
  <condition>Anal Fissure</condition>
  <condition>Perianal Fistula</condition>
  <arm_group>
    <arm_group_label>Group-1 (n: 50): Healthy cases</arm_group_label>
    <description>Control group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-2 (n:50): Grade 1 hemorroid</arm_group_label>
    <description>With perianal examination diagnosed of grade 1 hemorroidal disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-3 (n:50): Grade 2 hemorroid</arm_group_label>
    <description>With perianal examination diagnosed of grade 2 hemorroidal disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-4 (n:50): Anal fissure cases</arm_group_label>
    <description>With perianal examination diagnosed of anal fissure cases</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group-5 (n:50): Simple perianal fistula</arm_group_label>
    <description>With perianal examination diagnosed of uncomplicated, simple perianal fistula cases</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Life7</intervention_name>
    <description>Life7 will used on the perianal skin with finger tips</description>
    <arm_group_label>Group-1 (n: 50): Healthy cases</arm_group_label>
    <arm_group_label>Group-2 (n:50): Grade 1 hemorroid</arm_group_label>
    <arm_group_label>Group-3 (n:50): Grade 2 hemorroid</arm_group_label>
    <arm_group_label>Group-4 (n:50): Anal fissure cases</arm_group_label>
    <arm_group_label>Group-5 (n:50): Simple perianal fistula</arm_group_label>
    <other_name>Life 7</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      histopathological evaluation&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Older than 18 years old cases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Grade 1 and 2 hemorroidal disease&#xD;
&#xD;
          -  Cronic anal fissura&#xD;
&#xD;
          -  Uncomplicated simple perianal fistula&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any malign tumour&#xD;
&#xD;
          -  Cronic colorectal disases&#xD;
&#xD;
          -  Routine used of vasoactive medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>erhan aysan, MD Prof</last_name>
    <phone>+905322034879</phone>
    <phone_ext>4130</phone_ext>
    <email>erhanaysan@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fikrettin Sahin, Prof</last_name>
    <phone>+905338146547</phone>
    <phone_ext>4130</phone_ext>
    <email>fikrettinsahin@gmail.com</email>
  </overall_contact_backup>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yeditepe University</investigator_affiliation>
    <investigator_full_name>Erhan Aysan</investigator_full_name>
    <investigator_title>MD Prof</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
    <mesh_term>Fissure in Ano</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>December 24, 2020</submitted>
    <returned>January 22, 2021</returned>
    <submitted>November 21, 2021</submitted>
    <returned>January 26, 2022</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03780998
org study id: yeditepe university
nct id: NCT03780998
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
New produced and patented sodium pantaborat based gel will be use for treatment of benign
      perianal diseases (hemooroidal disease, anal fissura anda perianal fistula)
Prospective randomised clinical trial planned. Older than 18 years old perianal benign
      diseases (grade 1 and 2 hemorroidal disease, anal fissura, uncomplicated simple perianal
      fistula) cases without malign tumour, cronic colorectal disases, and routine used of
      vasoactive medication cases were entered the study. Younger than 18 years old, diagnosed any
      malign tumor and/or cronic colorectal disaeses, routine used of vasoact,ve mediaction cases
      were exclused of the study.

      Group-1 (n: 50): Healthy cases (control group) Group-2 (n:50): Grade 1 hemorroidal disease
      cases Group-3 (n:50): Grade 2 hemorroidal disease cases Group-4 (n:50): Anal fissure cases
      Group-5 (n:50): Uncomplicated, simple perianal fistula cases
observational model: Cohort
time perspective: Prospective
measure: Pain symtom differences
time frame: six months
description: Pain Scale from level 1 to level 10.
measure: Lowering of the grade of the hemorroidal disease (hemoroidal disease is four grades; grade 1, grade 2, grade 3, and grade 4)
time frame: six months
description: Surgeon general physical examination
measure: Closing of anal fissur line
time frame: six months
description: Surgeon general physical examination. Fissur line is exist or not exist
measure: Lowering of leakage amount of perianal fistule
time frame: six months
description: Three grade: lower, same, more
arm group label: Group-1 (n: 50): Healthy cases
description: Control group
arm group label: Group-2 (n:50): Grade 1 hemorroid
description: With perianal examination diagnosed of grade 1 hemorroidal disease
arm group label: Group-3 (n:50): Grade 2 hemorroid
description: With perianal examination diagnosed of grade 2 hemorroidal disease
arm group label: Group-4 (n:50): Anal fissure cases
description: With perianal examination diagnosed of anal fissure cases
arm group label: Group-5 (n:50): Simple perianal fistula
description: With perianal examination diagnosed of uncomplicated, simple perianal fistula cases
intervention type: Drug
intervention name: Life7
description: Life7 will used on the perianal skin with finger tips
arm group label: Group-1 (n: 50): Healthy cases
arm group label: Group-2 (n:50): Grade 1 hemorroid
arm group label: Group-3 (n:50): Grade 2 hemorroid
arm group label: Group-4 (n:50): Anal fissure cases
arm group label: Group-5 (n:50): Simple perianal fistula
other name: Life 7
histopathological evaluation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: erhan aysan, MD Prof
phone: +905322034879
phone ext: 4130
email: erhanaysan@hotmail.com
last name: Fikrettin Sahin, Prof
phone: +905338146547
phone ext: 4130
email: fikrettinsahin@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Yeditepe University
investigator full name: Erhan Aysan
investigator title: MD Prof
mesh term: Hemorrhoids
mesh term: Fissure in Ano
mesh term: Fistula
submitted: December 24, 2020
returned: January 22, 2021
submitted: November 21, 2021
returned: January 26, 2022