<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/NCT04418323</url>
  </required_header>
  <id_info>
    <org_study_id>R.19.03.453 - 2019/03/11</org_study_id>
    <nct_id>NCT04418323</nct_id>
  </id_info>
  <brief_title>Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula</brief_title>
  <official_title>Video-assisted Anal Fistula Treatment (VAAFT) Versus Fistula-tract Laser Closure (Filac) Versus Conventional Seton in the Management of Anal Fistula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal&#xD;
      with one or more than one external openings in the perianal skin Aim of the work This&#xD;
      prospective randomized control trial, we will compare video-assisted anal fistula treatment&#xD;
      (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate&#xD;
      as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital&#xD;
      stay, pain score, healing time, return to work and continence&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 16, 2020</start_date>
  <completion_date type="Anticipated">June 2, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recurrence of anal fistula</measure>
    <time_frame>one year</time_frame>
    <description>recurrence of anal fistula symptoms</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Video Assisted Anal Fistula Treatment</condition>
  <arm_group>
    <arm_group_label>Video-assisted anal fistula treatment (VAAFT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Video-assisted anal fistula treatment (VAAFT) in the Management of anal fistula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fistula-tract Laser Closure (filac)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fistula-tract Laser Closure (filac)in the Management of anal fistula</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional seton</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional seton in the Management of anal fistula</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula</intervention_name>
    <description>Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula</description>
    <arm_group_label>Conventional seton</arm_group_label>
    <arm_group_label>Fistula-tract Laser Closure (filac)</arm_group_label>
    <arm_group_label>Video-assisted anal fistula treatment (VAAFT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both genders aging between 18-65 years with cryptoglandular anal fistula&#xD;
             will be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We will exclude patients with associated anorectal pathology such as anal fissure,&#xD;
             hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel&#xD;
             diseases, and patients on long acting corticosteroids or immunosuppressive drugs will&#xD;
             be also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed Arnouse</last_name>
    <phone>01099222561</phone>
    <email>drmhamdy@mans.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Hamada Mohamed Hamada</last_name>
      <phone>+20 109 212 7930</phone>
      <email>irb.mfm@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rectal Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <!-- 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/NCT04418323
org study id: R.19.03.453 - 2019/03/11
nct id: NCT04418323
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Anal fistula is a chronic inflammatory tract connecting an internal opening in the anal canal
      with one or more than one external openings in the perianal skin Aim of the work This
      prospective randomized control trial, we will compare video-assisted anal fistula treatment
      (Vaaft) and Fistula Laser closure (Filac) and conventional Seton as regards, recurrence rate
      as a primary outcome. Secondary outcome includes; operative and post-operative data, hospital
      stay, pain score, healing time, return to work and continence
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recurrence of anal fistula
time frame: one year
description: recurrence of anal fistula symptoms
arm group label: Video-assisted anal fistula treatment (VAAFT
arm group type: Active Comparator
description: Video-assisted anal fistula treatment (VAAFT) in the Management of anal fistula
arm group label: Fistula-tract Laser Closure (filac)
arm group type: Active Comparator
description: Fistula-tract Laser Closure (filac)in the Management of anal fistula
arm group label: Conventional seton
arm group type: Active Comparator
description: Conventional seton in the Management of anal fistula
intervention type: Procedure
intervention name: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
description: Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
arm group label: Conventional seton
arm group label: Fistula-tract Laser Closure (filac)
arm group label: Video-assisted anal fistula treatment (VAAFT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Mohamed Arnouse
phone: 01099222561
email: drmhamdy@mans.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Rectal Fistula
mesh term: Fistula