<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/NCT03763981</url>
  </required_header>
  <id_info>
    <org_study_id>s5</org_study_id>
    <nct_id>NCT03763981</nct_id>
  </id_info>
  <brief_title>Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula</brief_title>
  <official_title>Comparison of Prolene Thread Seton Vs Silk Thread Seton for the Treatment of Perianal Fistula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Services Hospital, Lahore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Services Hospital, Lahore</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>
      It is a randomized control trial in which we will treat the patients with perianal fistula&#xD;
      with seton placement. We will divide the patients in two groups. Group I will be treated with&#xD;
      silk seton and Group II will be treated with prolene setone. The outcome will be then&#xD;
      followed as fistula healing and recurrence.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 30, 2018</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>fistula healing</measure>
    <time_frame>8 to 12 weeks</time_frame>
    <description>fistula healing, complete healing of wound with no external opening of fistula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fistula recurrence</measure>
    <time_frame>6 months</time_frame>
    <description>Recurrence of perianal fistula after treatment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Perianal Fistula</condition>
  <arm_group>
    <arm_group_label>prolene seton</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Prolene thread will be used as seton treatment for perianal fistulas</description>
  </arm_group>
  <arm_group>
    <arm_group_label>silk seton</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Silk thread will be used as seton treatment for perianal fistulas</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>prolene seton treatment</intervention_name>
    <description>patients with perianal fistulas will treated with seton placement by prolene thread</description>
    <arm_group_label>prolene seton</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>silk seton treatment</intervention_name>
    <description>patients with perianal fistulas will treated with seton placement by silk thread</description>
    <arm_group_label>silk seton</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of both sexes and aged 20 years and above with high perianal fistula&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Low perianal fistulas Fistulas due to chrons disease, TB or carcinoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahmmood Ayyaz, mbbs, fcps</last_name>
    <role>Study Director</role>
    <affiliation>Services Hospital, Lahore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Services hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>54000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 2, 2018</last_update_submitted>
  <last_update_submitted_qc>December 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Services Hospital, Lahore</investigator_affiliation>
    <investigator_full_name>Dr. SamiUllah</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03763981
org study id: s5
nct id: NCT03763981
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is a randomized control trial in which we will treat the patients with perianal fistula
      with seton placement. We will divide the patients in two groups. Group I will be treated with
      silk seton and Group II will be treated with prolene setone. The outcome will be then
      followed as fistula healing and recurrence.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: fistula healing
time frame: 8 to 12 weeks
description: fistula healing, complete healing of wound with no external opening of fistula
measure: Fistula recurrence
time frame: 6 months
description: Recurrence of perianal fistula after treatment
arm group label: prolene seton
arm group type: Active Comparator
description: Prolene thread will be used as seton treatment for perianal fistulas
arm group label: silk seton
arm group type: Active Comparator
description: Silk thread will be used as seton treatment for perianal fistulas
intervention type: Procedure
intervention name: prolene seton treatment
description: patients with perianal fistulas will treated with seton placement by prolene thread
arm group label: prolene seton
intervention type: Procedure
intervention name: silk seton treatment
description: patients with perianal fistulas will treated with seton placement by silk thread
arm group label: silk seton
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Mahmmood Ayyaz, mbbs, fcps
role: Study Director
affiliation: Services Hospital, Lahore
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: Services Hospital, Lahore
investigator full name: Dr. SamiUllah
investigator title: principal investigator
mesh term: Rectal Fistula
mesh term: Fistula
sharing ipd: Undecided