<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/NCT03271996</url>
  </required_header>
  <id_info>
    <org_study_id>11-016</org_study_id>
    <nct_id>NCT03271996</nct_id>
  </id_info>
  <brief_title>Fistulectomy vs. Modified Karydakis Procedure for Pilonidal Sinus</brief_title>
  <official_title>Two Surgical Techniques for the Treatment of Pilinidal Sinus: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dimitri Christoforidis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ente Ospedaliero Cantonale, Bellinzona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 wants to improve patient care affected by pilonidal sinus during and after&#xD;
      surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not&#xD;
      an appropriate surgical technique because of a lack of quality comparative studies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial. The study will compare the healing of the surgical&#xD;
      wound and the recurrence rate after excision and primary para-median closure versus narrow&#xD;
      orifice excision (fistulectomy)&#xD;
&#xD;
      Group A: excision and paramedian closure according to modified Karydakis technique&#xD;
&#xD;
      Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices,&#xD;
      healing of the wound by secondary intention&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>
    <intervention_model_description>Randomized controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete healing</measure>
    <time_frame>3 weeks</time_frame>
    <description>percentage of complete healing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to recovery</measure>
    <time_frame>12 months</time_frame>
    <description>Time to completely recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of relapse</measure>
    <time_frame>12 months</time_frame>
    <description>percentage of relapse after surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>Primary closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Excision of sinus and paramedian closure according to modified Karydakis technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fistulectomy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Primary closure</intervention_name>
    <description>Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.</description>
    <arm_group_label>Primary closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fistulectomy</intervention_name>
    <description>Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines</description>
    <arm_group_label>Fistulectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pilonidal cyst requiring surgery&#xD;
&#xD;
          -  Signed Informed Consent Form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal lesions&#xD;
&#xD;
          -  Injuries requiring a closing with rotation flap&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ospedale Regionale di Lugano</name>
      <address>
        <city>Lugnao</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>September 1, 2017</last_update_submitted>
  <last_update_submitted_qc>September 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ente Ospedaliero Cantonale, Bellinzona</investigator_affiliation>
    <investigator_full_name>Dimitri Christoforidis</investigator_full_name>
    <investigator_title>Vice-Chief in Surgery</investigator_title>
  </responsible_party>
  <keyword>Pilonidal sinus</keyword>
  <keyword>Bascom</keyword>
  <keyword>Cleft lift</keyword>
  <keyword>Fistulectomy</keyword>
  <keyword>Karydakis</keyword>
  <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>No</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/NCT03271996
org study id: 11-016
nct id: NCT03271996
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study wants to improve patient care affected by pilonidal sinus during and after
      surgery. Pilonidal sinus excision is a frequent procedure, despite this, there is still not
      an appropriate surgical technique because of a lack of quality comparative studies.
This is a randomized controlled trial. The study will compare the healing of the surgical
      wound and the recurrence rate after excision and primary para-median closure versus narrow
      orifice excision (fistulectomy)

      Group A: excision and paramedian closure according to modified Karydakis technique

      Group B: removal / fistulectomy by scalpels or trephines of primary and drainage orifices,
      healing of the wound by secondary intention
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled study
primary purpose: Treatment
masking: None (Open Label)
measure: Complete healing
time frame: 3 weeks
description: percentage of complete healing
measure: Time to recovery
time frame: 12 months
description: Time to completely recovery
measure: percentage of relapse
time frame: 12 months
description: percentage of relapse after surgery
arm group label: Primary closure
arm group type: Experimental
description: Excision of sinus and paramedian closure according to modified Karydakis technique
arm group label: Fistulectomy
arm group type: Experimental
description: Removal / fistulectomy by scalpels or trephines of primary and drainage orifices and healing of the wound by second intention
intervention type: Procedure
intervention name: Primary closure
description: Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
arm group label: Primary closure
intervention type: Procedure
intervention name: Fistulectomy
description: Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
arm group label: Fistulectomy
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Ente Ospedaliero Cantonale, Bellinzona
investigator full name: Dimitri Christoforidis
investigator title: Vice-Chief in Surgery
mesh term: Pilonidal Sinus
sharing ipd: No