<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/NCT02186964</url>
  </required_header>
  <id_info>
    <org_study_id>PS42</org_study_id>
    <nct_id>NCT02186964</nct_id>
  </id_info>
  <brief_title>Comparison of Tension Free Primary Closure, Karydaks and Limberg Flap Methods</brief_title>
  <official_title>Randomised Prospective Comparison of Tension-free Primary Closure, Karydakis and Limberg Flap Methods in Treatment of Pilonidal Sinus Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konya Meram State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konya Meram State Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen&#xD;
      in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is&#xD;
      found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.&#xD;
&#xD;
      There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in&#xD;
      between those methods is the closing of the defect that occurs after the excision of the&#xD;
      sinus tract. The defect can be closed by primary sutures or it can be left for secondary&#xD;
      healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap&#xD;
      procedures are commonly used. However, it has been reported that there is no difference&#xD;
      between flap procedures and tension free primary closure. This result triggered the&#xD;
      controversy that; if the healing side is tension free, midline suturing may have no&#xD;
      importance. The aim of this study is to compare the results of 3 different surgical&#xD;
      procedures used in treatment of pilonidal disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2011</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">August 2012</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>2 years</time_frame>
    <description>recurrence rates two years after the surgery</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Pilonidal Disease</condition>
  <condition>Recurrence</condition>
  <condition>Complication</condition>
  <arm_group>
    <arm_group_label>tension free primary closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients treated by tension free primary closure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>karydakis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients treated by Karydakis method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limberg flap</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients treated by Limberg flap procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>tension free primary closure</intervention_name>
    <description>tension free primary closure of the defects created by excision of the pilonidal sinus</description>
    <arm_group_label>tension free primary closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>karydakis</intervention_name>
    <description>the defect after excision of the pilonidal sinus is closed by Karydakis procedure</description>
    <arm_group_label>karydakis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limberg flap</intervention_name>
    <description>defect after excision of the pilonidal sinus is closed by Limberg flap procedure</description>
    <arm_group_label>Limberg flap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  having pilonidal sinus disease&#xD;
&#xD;
          -  desire for surgical treatment&#xD;
&#xD;
          -  accept to be involved in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients under age of 18&#xD;
&#xD;
          -  recurrent cases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ömer Karahan, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Konya Meram State Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Konya Training and Research Hospital</name>
      <address>
        <city>Konya</city>
        <zip>42180</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 8, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>July 9, 2014</last_update_submitted>
  <last_update_submitted_qc>July 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konya Meram State Hospital</investigator_affiliation>
    <investigator_full_name>barış sevinç</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Recurrence</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/NCT02186964
org study id: PS42
nct id: NCT02186964
lead sponsor: 
has dmc: No
Pilonidal sinus is a chronic inflammatory disorder of intergluteal sulcus. The disease seen
      in between 15-35 years of age and 3-4 times more in males. The incidence of the disease is
      found as 8.8% in Turkish soldiers. The disorder mainly affects the quality of life.

      There are numerous methods in surgical treatment of Pilonidal sinus. The main difference in
      between those methods is the closing of the defect that occurs after the excision of the
      sinus tract. The defect can be closed by primary sutures or it can be left for secondary
      healing. Nowadays, the recurrence rate of flap procedures are lower therefore, flap
      procedures are commonly used. However, it has been reported that there is no difference
      between flap procedures and tension free primary closure. This result triggered the
      controversy that; if the healing side is tension free, midline suturing may have no
      importance. The aim of this study is to compare the results of 3 different surgical
      procedures used in treatment of pilonidal disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recurrence
time frame: 2 years
description: recurrence rates two years after the surgery
arm group label: tension free primary closure
arm group type: Experimental
description: patients treated by tension free primary closure
arm group label: karydakis
arm group type: Experimental
description: patients treated by Karydakis method
arm group label: Limberg flap
arm group type: Experimental
description: patients treated by Limberg flap procedure
intervention type: Procedure
intervention name: tension free primary closure
description: tension free primary closure of the defects created by excision of the pilonidal sinus
arm group label: tension free primary closure
intervention type: Procedure
intervention name: karydakis
description: the defect after excision of the pilonidal sinus is closed by Karydakis procedure
arm group label: karydakis
intervention type: Procedure
intervention name: Limberg flap
description: defect after excision of the pilonidal sinus is closed by Limberg flap procedure
arm group label: Limberg flap
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ömer Karahan, Professor
role: Study Director
affiliation: Konya Meram State Hospital
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Konya Meram State Hospital
investigator full name: barış sevinç
investigator title: MD
mesh term: Recurrence