<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/NCT01662765</url>
  </required_header>
  <id_info>
    <org_study_id>MK-003-UPS</org_study_id>
    <nct_id>NCT01662765</nct_id>
  </id_info>
  <brief_title>Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease</brief_title>
  <official_title>Conservative Versus Surgical Treatment of Umbilical Pilonidal Sinus Disease: A Prospective, Randomised, and Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical Park Gaziantep Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Zeugma Saglik Hizmetleri San. Tic. Ltd. Sti.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical Park Gaziantep Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to compare the results of conservative and surgical treatment, to&#xD;
      create an algorithm for the management of the disease, and gain more information about the&#xD;
      etiology, pathogenesis, and course of the disease. The investigators hypothesise that&#xD;
      surgical treatment of UPS will be better than conservative management in terms of recurrence&#xD;
      rate, healing time, patient comfort and satisfaction, and cost effectiveness.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of&#xD;
      diagnosis, etiology, and the best treatment options.&#xD;
&#xD;
      UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and&#xD;
      development of a sinus lined with granulation tissue. Most of the patients complain of pain,&#xD;
      discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a&#xD;
      careful examination, in which hairs can be seen deep in the umbilicus and usually protrude&#xD;
      from a small sinus.&#xD;
&#xD;
      Regarding the optimal treatment of the disease, a complete consensus has not yet been&#xD;
      achieved. Some publications are recommended conservative treatment, while surgical treatment&#xD;
      is recommended in others.&#xD;
&#xD;
      A more meaningful comparison of the two modalities is that of a randomized controlled trial.&#xD;
      We, therefore, present our data of prospective randomized controlled clinical trial comparing&#xD;
      conservative versus surgical treatment of UPS.&#xD;
&#xD;
      This was a multicenter, prospective balanced randomization, double blind, active-controlled,&#xD;
      parallel-group, superiority study conducted in Turkey, under the direction of a principal&#xD;
      investigator (MK). Eligible patients with UPS were randomized for either conservative&#xD;
      treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2003</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2010</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cure Rate</measure>
    <time_frame>2 year after initial treatment</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>two year</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>
  <secondary_outcome>
    <measure>Visual Analogue Scale for Patient Satisfaction (VAS-PS)</measure>
    <time_frame>30 days</time_frame>
    <description>Well-being and satisfaction scales comprised linear metric scales known as &quot;visual analogue scales,&quot; with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Costs</measure>
    <time_frame>two year</time_frame>
    <description>from initial treatment to the complete healing, all kind of cost will be calculated.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Pilonidal Sinus</condition>
  <condition>Sinus; Dermal, Pilonidal</condition>
  <condition>Umbilical Granuloma</condition>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.&#xD;
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conservative</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.&#xD;
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgery</intervention_name>
    <description>modified umbilectomy</description>
    <arm_group_label>Surgery</arm_group_label>
    <other_name>umbilectomy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conservative</intervention_name>
    <description>this treatment will include conservative procedures under local anesthesia for patient comfort.</description>
    <arm_group_label>Conservative</arm_group_label>
    <other_name>non-surgical management</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients willing to participate to the study with the diagnosis of umbilical&#xD;
             pilonidal sinus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no informed consent&#xD;
&#xD;
          -  serious coagulation abnormalities&#xD;
&#xD;
          -  known allergy to local anesthetics&#xD;
&#xD;
          -  pregnancy, or women who refused contraception at the time of treatment&#xD;
&#xD;
          -  other concomitant umbilical pathologies such as umbilical hernia, granuloma, dermoid&#xD;
             cyst&#xD;
&#xD;
          -  the patients who diagnosed with urachal and omphalomesenteric anomalies through&#xD;
             radiological investigation&#xD;
&#xD;
          -  patients who underwent umbilical operation&#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, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical Park Gaziantep Hospital, Gaziantep, Turkey</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hatem Hospital</name>
      <address>
        <city>Gaziantep</city>
        <zip>27090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Park Gaziantep Hospital</name>
      <address>
        <city>Gaziantep</city>
        <zip>27090</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>25 Aralık Familiy Physician Health Center</name>
      <address>
        <city>Gaziantep</city>
        <zip>27100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr.Ersin Arslan State Hospital</name>
      <address>
        <city>Gaziantep</city>
        <zip>27100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Şehitkamil State Hospital</name>
      <address>
        <city>Gaziantep</city>
        <zip>27100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>http://www.medicalpark.com.tr</url>
    <description>main study center</description>
  </link>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>January 18, 2016</results_first_submitted>
  <results_first_submitted_qc>December 23, 2016</results_first_submitted_qc>
  <results_first_posted type="Actual">February 16, 2017</results_first_posted>
  <last_update_submitted>December 23, 2016</last_update_submitted>
  <last_update_submitted_qc>December 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 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>
  <keyword>Treatment</keyword>
  <keyword>Surgery</keyword>
  <keyword>Conservative</keyword>
  <keyword>Investigational treatment</keyword>
  <keyword>After care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilonidal Sinus</mesh_term>
    <mesh_term>Granuloma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Conservative</title>
          <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.&#xD;
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.&#xD;
conservative: this treatment will include conservative procedures under local anesthesia for patient comfort.</description>
        </group>
        <group group_id="P2">
          <title>Surgery</title>
          <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.&#xD;
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="42"/>
                <participants group_id="P2" count="42"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Conservative</title>
          <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.&#xD;
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.</description>
        </group>
        <group group_id="B2">
          <title>Surgery</title>
          <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.&#xD;
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="42"/>
            <count group_id="B2" value="42"/>
            <count group_id="B3" value="84"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21.80" lower_limit="12" upper_limit="34"/>
                    <measurement group_id="B2" value="19.86" lower_limit="10" upper_limit="37"/>
                    <measurement group_id="B3" value="20.83" lower_limit="10" upper_limit="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cure Rate</title>
        <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>
        <time_frame>2 year after initial treatment</time_frame>
        <population>Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed</population>
        <group_list>
          <group group_id="O1">
            <title>Conservative</title>
            <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.&#xD;
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.&#xD;
conservative: this treatment will include conservative procedures under local anesthesia for patient comfort.</description>
          </group>
          <group group_id="O2">
            <title>Surgery</title>
            <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.&#xD;
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.</description>
          </group>
        </group_list>
        <measure>
          <title>Cure Rate</title>
          <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>
          <population>Of the 84 patients 41 patients in the CT group. and 40 patients in ST group were analyzed</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="41"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healing Time</title>
        <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>
        <time_frame>two year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surgery</title>
            <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.&#xD;
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.&#xD;
Surgery: modified umbilectomy</description>
          </group>
          <group group_id="O2">
            <title>Conservative</title>
            <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.&#xD;
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.&#xD;
conservative: this treatment will include conservative procedures under local anesthesia for patient comfort.</description>
          </group>
        </group_list>
        <measure>
          <title>Healing Time</title>
          <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>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.81" spread="2.96"/>
                    <measurement group_id="O2" value="17.06" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Analogue Scale for Patient Satisfaction (VAS-PS)</title>
        <description>Well-being and satisfaction scales comprised linear metric scales known as &quot;visual analogue scales,&quot; with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).</description>
        <time_frame>30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conservative</title>
            <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.</description>
          </group>
          <group group_id="O2">
            <title>Surgery</title>
            <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Analogue Scale for Patient Satisfaction (VAS-PS)</title>
          <description>Well-being and satisfaction scales comprised linear metric scales known as &quot;visual analogue scales,&quot; with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="33"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66" spread="8"/>
                    <measurement group_id="O2" value="71" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Costs</title>
        <description>from initial treatment to the complete healing, all kind of cost will be calculated.</description>
        <time_frame>two year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Conservative</title>
            <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.</description>
          </group>
          <group group_id="O2">
            <title>Surgery</title>
            <description>Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.</description>
          </group>
        </group_list>
        <measure>
          <title>Costs</title>
          <description>from initial treatment to the complete healing, all kind of cost will be calculated.</description>
          <units>USD dollars</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="42"/>
                <count group_id="O2" value="42"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="609" spread="224"/>
                    <measurement group_id="O2" value="479" spread="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Conservative</title>
          <description>Conservative treatment described as follow:&#xD;
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.</description>
        </group>
        <group group_id="E2">
          <title>Surgery</title>
          <description>Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.&#xD;
Approximation of the subcutaneous tissue with a single purse-string absorbable suture.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="42"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="42"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Mehmet Kaplan</name_or_title>
      <organization>Bahcesehir University, School of Medicine</organization>
      <phone>+905056268899</phone>
      <email>dr.kaplan27@gmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01662765
org study id: MK-003-UPS
nct id: NCT01662765
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of the study was to compare the results of conservative and surgical treatment, to
      create an algorithm for the management of the disease, and gain more information about the
      etiology, pathogenesis, and course of the disease. The investigators hypothesise that
      surgical treatment of UPS will be better than conservative management in terms of recurrence
      rate, healing time, patient comfort and satisfaction, and cost effectiveness.
Because of its rarity, umbilical pilonidal sinus (UPS) is still poorly understood in terms of
      diagnosis, etiology, and the best treatment options.

      UPS is thought caused by hair penetrating the skin, leading to a foreign-body reaction and
      development of a sinus lined with granulation tissue. Most of the patients complain of pain,
      discharge or bleeding from the umbilicus when symptoms develop. It can be diagnosed with a
      careful examination, in which hairs can be seen deep in the umbilicus and usually protrude
      from a small sinus.

      Regarding the optimal treatment of the disease, a complete consensus has not yet been
      achieved. Some publications are recommended conservative treatment, while surgical treatment
      is recommended in others.

      A more meaningful comparison of the two modalities is that of a randomized controlled trial.
      We, therefore, present our data of prospective randomized controlled clinical trial comparing
      conservative versus surgical treatment of UPS.

      This was a multicenter, prospective balanced randomization, double blind, active-controlled,
      parallel-group, superiority study conducted in Turkey, under the direction of a principal
      investigator (MK). Eligible patients with UPS were randomized for either conservative
      treatment (CT) or surgical treatment (ST), and then the results of both groups were compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Cure Rate
time frame: 2 year after initial treatment
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: two year
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.
measure: Visual Analogue Scale for Patient Satisfaction (VAS-PS)
time frame: 30 days
description: Well-being and satisfaction scales comprised linear metric scales known as "visual analogue scales," with grades from 0 (worst imaginable health state and extremely dissatisfied with the treatment) to 100 (best imaginable health state and extremely satisfied with the treatment).
measure: Costs
time frame: two year
description: from initial treatment to the complete healing, all kind of cost will be calculated.
arm group label: Surgery
arm group type: Experimental
description: Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.
arm group label: Conservative
arm group type: Active Comparator
description: Conservative treatment described as follow:
Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.
postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.
intervention type: Procedure
intervention name: Surgery
description: modified umbilectomy
arm group label: Surgery
other name: umbilectomy
intervention type: Other
intervention name: conservative
description: this treatment will include conservative procedures under local anesthesia for patient comfort.
arm group label: Conservative
other name: non-surgical management
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mehmet KAPLAN, MD
role: Principal Investigator
affiliation: Medical Park Gaziantep Hospital, Gaziantep, Turkey
facility: 
facility: 
facility: 
facility: 
facility: 
country: Turkey
url: http://www.medicalpark.com.tr
description: main study center
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: Granuloma
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 