<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/NCT02222298</url>
  </required_header>
  <id_info>
    <org_study_id>framar</org_study_id>
    <nct_id>NCT02222298</nct_id>
  </id_info>
  <brief_title>Video Assisted Ablation of Pilonidal Sinus Versus Conventional Treatment</brief_title>
  <official_title>Video Assisted Ablation of Pilonidal Sinus Versus Convention Off-midline Bas Com Cleft Lift Procedure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <brief_summary>
    <textblock>
      Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive&#xD;
      treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have&#xD;
      designed a comparative study between the conventional and the minimally invasive treatment.&#xD;
      Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision&#xD;
      with a Bascom out-midline closure (Control group).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <primary_completion_date type="Actual">November 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infection</measure>
    <time_frame>at 30 days after surgery</time_frame>
    <description>Wound infection was defined as redness and/or oedema of the skin and/or discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>recurrence</measure>
    <time_frame>at 1 year after surgery</time_frame>
    <description>recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>return at work</measure>
    <time_frame>up to 30 days after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>up to 30 days after surgery</time_frame>
    <description>A vas-score scale (0-10) will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction</measure>
    <time_frame>up to six months after surgery</time_frame>
    <description>a Vas-score scale (0-10) and a SF_36 model will be used</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Chronic Sacrococcygeal Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>VAAPS group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients undergoing video assisted ablation of pilonidal sinus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients undergoing conventional off-midline Bascom cleft lift procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Video assisted ablation of pilonidal sinus</intervention_name>
    <description>A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.</description>
    <arm_group_label>VAAPS group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bascom Cleft lift procedure</intervention_name>
    <arm_group_label>conventional treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic sacrococcygeal pilonidal sinus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Absence of consent to the study&#xD;
&#xD;
          -  Acute abscess&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Naples &quot;Federico II&quot;</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>November 2, 2015</last_update_submitted>
  <last_update_submitted_qc>November 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Francesco Milone</investigator_full_name>
    <investigator_title>Professor of Surgery</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>
  <!-- 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/NCT02222298
org study id: framar
nct id: NCT02222298
lead sponsor: 
Video assisted ablation of pilonidal sinus (VAAPS) is a new endoscopic minimally invasive
      treatment. In an attempt to validate the effectiveness of the VAAPS, the investigators have
      designed a comparative study between the conventional and the minimally invasive treatment.
      Two surgical procedures were evaluated: VAAPS (Experimental group) and conventional excision
      with a Bascom out-midline closure (Control group).
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Infection
time frame: at 30 days after surgery
description: Wound infection was defined as redness and/or oedema of the skin and/or discharge.
measure: recurrence
time frame: at 1 year after surgery
description: recurrence was defined when symptoms of the disease recurred after an interval following complete wound healing.
measure: return at work
time frame: up to 30 days after surgery
measure: Pain
time frame: up to 30 days after surgery
description: A vas-score scale (0-10) will be used
measure: satisfaction
time frame: up to six months after surgery
description: a Vas-score scale (0-10) and a SF_36 model will be used
arm group label: VAAPS group
arm group type: Experimental
description: patients undergoing video assisted ablation of pilonidal sinus
arm group label: conventional treatment group
arm group type: Active Comparator
description: patients undergoing conventional off-midline Bascom cleft lift procedure
intervention type: Procedure
intervention name: Video assisted ablation of pilonidal sinus
description: A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.
arm group label: VAAPS group
intervention type: Procedure
intervention name: Bascom Cleft lift procedure
arm group label: conventional treatment group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Francesco Milone
investigator title: Professor of Surgery
mesh term: Pilonidal Sinus