<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/NCT04418310</url>
  </required_header>
  <id_info>
    <org_study_id>Epsit Pilonidal sinus</org_study_id>
    <nct_id>NCT04418310</nct_id>
  </id_info>
  <brief_title>Intervetional Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease</brief_title>
  <official_title>Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease</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 lay open technique versus Endoscopic pilonidal sinus treatment as&#xD;
      regards recurrence rate, operative data, postoperative pain, intra and postoperative&#xD;
      complications, healing time and return to daily activity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction Pilonidal sinus is a very common inflammatory disease of gluteal region&#xD;
      (McCallum et al., 2008). Its incidence is 26/100,000 and it usually occurs in working males&#xD;
      of age 15 to 30.&#xD;
&#xD;
      The disease itself dates back to 1833 when Herbert Mayo, British Physiologist, Anatomist and&#xD;
      Surgeon described it as a sinus containing hair follicles located in the sacrococcygeal&#xD;
      region in a woman.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 12, 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">June 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 rate</measure>
    <time_frame>one year</time_frame>
    <description>recurrence rate of pilonidal sinus symptoms after healing</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Endoscopic Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>Lay open and curettage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Lay open and curettage in Pilonidal sinus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopic (E.P.Si.T) method</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lay open and curettage</intervention_name>
    <description>Lay open and curettage</description>
    <arm_group_label>Lay open and curettage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Endoscopic (E.P.Si.T) method</intervention_name>
    <description>Endoscopic (E.P.Si.T) method</description>
    <arm_group_label>Endoscopic (E.P.Si.T) method</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients of both genders with symptoms from sacrococcygeal pilonidal sinus were&#xD;
             included in our study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abscess formation 2. Immunodeficiency. 3. Patients with congenital asymptomatic pits.&#xD;
             4. Patient with psychiatric disease disabling surgical intervention. 5. Pregnant&#xD;
             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>
  <overall_contact_backup>
    <last_name>Mahmoud Abdelnaby</last_name>
    <phone>01099222561</phone>
    <email>Abdelshafymahmoud@gmail.com</email>
  </overall_contact_backup>
  <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 4, 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>Pilonidal Sinus</mesh_term>
    <mesh_term>Paranasal Sinus Diseases</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/NCT04418310
org study id: Epsit Pilonidal sinus
nct id: NCT04418310
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the work To compare 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
Introduction Pilonidal sinus is a very common inflammatory disease of gluteal region
      (McCallum et al., 2008). Its incidence is 26/100,000 and it usually occurs in working males
      of age 15 to 30.

      The disease itself dates back to 1833 when Herbert Mayo, British Physiologist, Anatomist and
      Surgeon described it as a sinus containing hair follicles located in the sacrococcygeal
      region in a woman.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recurrence rate
time frame: one year
description: recurrence rate of pilonidal sinus symptoms after healing
arm group label: Lay open and curettage
arm group type: Active Comparator
description: Lay open and curettage in Pilonidal sinus
arm group label: Endoscopic (E.P.Si.T) method
arm group type: Active Comparator
description: Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease
intervention type: Procedure
intervention name: Lay open and curettage
description: Lay open and curettage
arm group label: Lay open and curettage
intervention type: Procedure
intervention name: Endoscopic (E.P.Si.T) method
description: Endoscopic (E.P.Si.T) method
arm group label: Endoscopic (E.P.Si.T) method
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
last name: Mahmoud Abdelnaby
phone: 01099222561
email: Abdelshafymahmoud@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor
mesh term: Pilonidal Sinus
mesh term: Paranasal Sinus Diseases