<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/NCT03007173</url>
  </required_header>
  <id_info>
    <org_study_id>MK-013-UPS</org_study_id>
    <nct_id>NCT03007173</nct_id>
  </id_info>
  <brief_title>Umbilical Pilonidal Sinus: a Case Report</brief_title>
  <official_title>Umbilical Pilonidal Sinus: an Underestimated and Little-known Clinical Entity - Report of Two Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Park Gaziantep Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical Park Gaziantep Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep&#xD;
      navels and poor personal hygiene; however, it can be seen in females. UPS could easily be&#xD;
      misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis&#xD;
      is easy to establish with physical examination and a detailed history. Treatment is generally&#xD;
      depending on the severity of the disease, ranging from good personal hygiene to surgical&#xD;
      excision of umbilical complex. The treatment of choice for chronic, intermittent cases is&#xD;
      surgical removal of the affected portion; paying special attention to cosmetic appearance&#xD;
      especially in female patients. In this report, we present two cases of UPS, one in a man and&#xD;
      one in a woman with the explanation of its etiopathogenesis and surgical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men&#xD;
      with deep navels and poor personal hygiene. It is being diagnosed and reported more&#xD;
      frequently; however, there is still no consensus regarding its best treatment options.&#xD;
&#xD;
      Presentation of cases: In this report, we present two cases of UPS, one in a man and one in a&#xD;
      woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from&#xD;
      the umbilicus. They had small sinus openings with hair protruding deep in the navel. Because&#xD;
      patients had previous history of failed conservative treatments an umbilicus preserving&#xD;
      surgery was performed for both cases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>cure rate</measure>
    <time_frame>within 2 years of follow-up</time_frame>
    <description>Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.&#xD;
Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>healing time</measure>
    <time_frame>within the postoperative 1 month</time_frame>
    <description>the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.</description>
  </secondary_outcome>
  <enrollment type="Actual">2</enrollment>
  <condition>Umbilical Cyst</condition>
  <condition>Pilonidal Sinus</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>umbilicus preserving surgery</intervention_name>
    <description>excision of umbilical complex</description>
    <other_name>pilonidal sinus excision</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      soft tissue composed of umbilical cyst&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        No limitation for age, gender, ethnicity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no limitation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients followed-up less than 2 years&#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_official>
    <last_name>Mehmet Kaplan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Park Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mehmet Kaplan</name>
      <address>
        <city>Gaziantep</city>
        <zip>27090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kaplan M, Ozcan O, Kaplan FC, Yalcin HC, Salman B. Conservative vs Surgical Interventions for Umbilical Pilonidal Sinus: A Multicenter, Double-Blind, Prospective, Randomized Clinical Trial. J Am Coll Surg. 2016 May;222(5):878-89. doi: 10.1016/j.jamcollsurg.2016.01.056. Epub 2016 Feb 23.</citation>
    <PMID>27016906</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical Park Gaziantep Hospital</investigator_affiliation>
    <investigator_full_name>Mehmet Kaplan</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>umbilical pilonidal sinus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilonidal Sinus</mesh_term>
    <mesh_term>Urachal Cyst</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/NCT03007173
org study id: MK-013-UPS
nct id: NCT03007173
lead sponsor: 
has dmc: No
Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men with deep
      navels and poor personal hygiene; however, it can be seen in females. UPS could easily be
      misdiagnosed and mistreated due to its rarity and lack of awareness in physicians. Diagnosis
      is easy to establish with physical examination and a detailed history. Treatment is generally
      depending on the severity of the disease, ranging from good personal hygiene to surgical
      excision of umbilical complex. The treatment of choice for chronic, intermittent cases is
      surgical removal of the affected portion; paying special attention to cosmetic appearance
      especially in female patients. In this report, we present two cases of UPS, one in a man and
      one in a woman with the explanation of its etiopathogenesis and surgical treatment.
Introduction: Umbilical pilonidal sinus (UPS) is a rare disease of young, hirsute, dark men
      with deep navels and poor personal hygiene. It is being diagnosed and reported more
      frequently; however, there is still no consensus regarding its best treatment options.

      Presentation of cases: In this report, we present two cases of UPS, one in a man and one in a
      woman who had typical symptoms with pain, swelling and intermittent malodorous discharge from
      the umbilicus. They had small sinus openings with hair protruding deep in the navel. Because
      patients had previous history of failed conservative treatments an umbilicus preserving
      surgery was performed for both cases.
observational model: Case-Only
time perspective: Prospective
measure: cure rate
time frame: within 2 years of follow-up
description: Primary outcome was the cure rate. Absence of recurrence within two year after the first treatment was considered as a cure.
Recurrence was defined as the appearance of a new, active discharging sinus or granulation tissue with/without a bit of hairs in the deep of the umbilicus within two years after therapy.
measure: healing time
time frame: within the postoperative 1 month
description: the time form initial treatment to healing the wound and/or sinus and/or granulation tissue and no any sign of drainage with no longer need for dressing and wound care in either treatment arms.
intervention type: Procedure
intervention name: umbilicus preserving surgery
description: excision of umbilical complex
other name: pilonidal sinus excision
soft tissue composed of umbilical cyst
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mehmet Kaplan, M.D.
role: Principal Investigator
affiliation: Medical Park Hospital
facility: 
country: Turkey
citation: Kaplan M, Ozcan O, Kaplan FC, Yalcin HC, Salman B. Conservative vs Surgical Interventions for Umbilical Pilonidal Sinus: A Multicenter, Double-Blind, Prospective, Randomized Clinical Trial. J Am Coll Surg. 2016 May;222(5):878-89. doi: 10.1016/j.jamcollsurg.2016.01.056. Epub 2016 Feb 23.
PMID: 27016906
responsible party type: Principal Investigator
investigator affiliation: Medical Park Gaziantep Hospital
investigator full name: Mehmet Kaplan
investigator title: Principal Investigator
mesh term: Pilonidal Sinus
mesh term: Urachal Cyst
sharing ipd: No