<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/NCT04418336</url>
  </required_header>
  <id_info>
    <org_study_id>R.19.04.495.R1 - 2019/05/12</org_study_id>
    <nct_id>NCT04418336</nct_id>
  </id_info>
  <brief_title>Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique</brief_title>
  <official_title>Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique</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>
      Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic&#xD;
      pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain,&#xD;
      intra and postoperative complications, healing time and return to daily activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 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</measure>
    <time_frame>one year</time_frame>
    <description>Recurrence of pilonidal sinus after treatment</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>Endoscopic Pilonidal sinus treatment (EPSIT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic Pilonidal sinus treatment (EPSIT)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sinus Laser Closure (SiLaC)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sinus Laser Closure (SiLaC)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>lay open technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>lay open technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique</intervention_name>
    <description>Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment</description>
    <arm_group_label>Endoscopic Pilonidal sinus treatment (EPSIT)</arm_group_label>
    <arm_group_label>Sinus Laser Closure (SiLaC)</arm_group_label>
    <arm_group_label>lay open technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with symptoms from sacrococcygeal pilonidal sinus .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abscess formation&#xD;
&#xD;
          -  Immunodeficiency.&#xD;
&#xD;
          -  Patients with congenital asymptomatic pits.&#xD;
&#xD;
          -  Patient with psychiatric disease disabling surgical intervention. . Pregnant females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</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 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 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>Pilonidal Sinus</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/NCT04418336
org study id: R.19.04.495.R1 - 2019/05/12
nct id: NCT04418336
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic
      pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain,
      intra and postoperative complications, healing time and return to daily activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence
time frame: one year
description: Recurrence of pilonidal sinus after treatment
arm group label: Endoscopic Pilonidal sinus treatment (EPSIT)
arm group type: Active Comparator
description: Endoscopic Pilonidal sinus treatment (EPSIT)
arm group label: Sinus Laser Closure (SiLaC)
arm group type: Active Comparator
description: Sinus Laser Closure (SiLaC)
arm group label: lay open technique
arm group type: Active Comparator
description: lay open technique
intervention type: Procedure
intervention name: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique
description: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment
arm group label: Endoscopic Pilonidal sinus treatment (EPSIT)
arm group label: Sinus Laser Closure (SiLaC)
arm group label: lay open technique
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
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: Pilonidal Sinus