<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/NCT03765086</url>
  </required_header>
  <id_info>
    <org_study_id>s7</org_study_id>
    <nct_id>NCT03765086</nct_id>
  </id_info>
  <brief_title>Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus</brief_title>
  <official_title>Karydakis Procedure Vs Limberg Flap in Treatment of Sacrococcygeal Pilonidal Sinus</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>
      This study will be a randomized controlled trial in which there will be comparison of the&#xD;
      effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal&#xD;
      pilonidal sinus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">July 1, 2018</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Percentage of patients presenting with recurrence of pilonidal sinus</measure>
    <time_frame>8 to 12 weeks</time_frame>
    <description>Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of weeks in which the operative wound will be healed</measure>
    <time_frame>4 to 6 weeks</time_frame>
    <description>Duration of wound healing (complete epithelization of wound )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of patients developing postoperative pain</measure>
    <time_frame>3 days</time_frame>
    <description>postoperative pain( measured by visual analog score with 1 being minimum score and 10 being maximum score) after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>Karydakis procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Karydakis Procedure: In this procedure the pilonidal sinus will be excised by semilunar incision so that the incision line closure will be away from midline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Limberg Flap</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Limberg Flap: In this procedure the pilonidal sinus will be excised by diamond shaped incision and the defect will be closed by random pattern flap.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Karydakis procedure</intervention_name>
    <description>Pilonidal sinus will be excised by Karydakis procedure</description>
    <arm_group_label>Karydakis procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Limberg Flap</intervention_name>
    <description>Pilonidal sinus will be excised by Limberg Flap</description>
    <arm_group_label>Limberg Flap</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with pilonidal sinus of any sex and aged 20 years or above&#xD;
&#xD;
          -  Non infected pilonidal sinus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infected pilonidal sinus&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Patient on immunosuppressive therapy&#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>February 2019</verification_date>
  <study_first_submitted>July 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 2, 2019</last_update_submitted>
  <last_update_submitted_qc>February 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</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>Medical Officer</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilonidal Sinus</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/NCT03765086
org study id: s7
nct id: NCT03765086
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study will be a randomized controlled trial in which there will be comparison of the
      effectiveness of Karydakis procedure and Limberg flap in treatment of sacrococcygeal
      pilonidal sinus
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of patients presenting with recurrence of pilonidal sinus
time frame: 8 to 12 weeks
description: Recurrence of Pilonidal Sinus(described as appearance of multiple discharging sinuses in operative site) after surgical procedure
measure: Number of weeks in which the operative wound will be healed
time frame: 4 to 6 weeks
description: Duration of wound healing (complete epithelization of wound )
measure: percentage of patients developing postoperative pain
time frame: 3 days
description: postoperative pain( measured by visual analog score with 1 being minimum score and 10 being maximum score) after surgery
arm group label: Karydakis procedure
arm group type: Active Comparator
description: Karydakis Procedure: In this procedure the pilonidal sinus will be excised by semilunar incision so that the incision line closure will be away from midline.
arm group label: Limberg Flap
arm group type: Active Comparator
description: Limberg Flap: In this procedure the pilonidal sinus will be excised by diamond shaped incision and the defect will be closed by random pattern flap.
intervention type: Procedure
intervention name: Karydakis procedure
description: Pilonidal sinus will be excised by Karydakis procedure
arm group label: Karydakis procedure
intervention type: Procedure
intervention name: Limberg Flap
description: Pilonidal sinus will be excised by Limberg Flap
arm group label: Limberg Flap
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: Medical Officer
mesh term: Pilonidal Sinus
sharing ipd: Undecided