xml: <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/NCT06021392</url>
    </required_header>
    <id_info>
      <org_study_id>Techniques of PNS excision</org_study_id>
      <nct_id>NCT06021392</nct_id>
    </id_info>
    <brief_title>Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus</brief_title>
    <official_title>Comparative Study Between Wide Local Excision and Minimal Excision of Pilonidal Sinus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abanoub emad fayez</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
        Comparative study between wide local excision and minimal excision of pilonidal sinus&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pilonidal sinus (PNS) disease is distributed in young adults who are supposed to be healthy&#xD;
        with maximum productivity. Wide local excision creates a tissue gap, while the concept of&#xD;
        minimal excision preserves healthy tissues with minimal tissue gap.&#xD;
  &#xD;
        Pilonidal disease is a frequent suppurative condition that occurs twice as often in men as in&#xD;
        women, usually between the ages of 15 and 30. Pilonidal disease is located beneath the skin&#xD;
        of the sacro-coccygeal region. It presents acutely as an abscess under tension while the&#xD;
        chronic form gives rise to intermittent discharge from pilonidal sinus(es). Diagnosis is&#xD;
        clinical and usually straightforward. In the large majority of cases, treatment is surgical&#xD;
        but there is no consensus as to the 'ideal' technique. Acute abscess must be evacuated and an&#xD;
        off-midline incision seems preferable. Excision is the standard definitive treatment but the&#xD;
        choice of wide versus limited excision on the school of thought. Minimal excision or&#xD;
        debridement of the sinus and/or cavity through a midline or a separate paramedian excision&#xD;
        can also be performed, leaving the wounds open or closed. These methods are simple and&#xD;
        cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal&#xD;
        activity. A disadvantage is the higher recurrence rate; however, these methods can be used&#xD;
        repeatedly for recurrences. Although recurrence rates seem high at first glance, the&#xD;
        procedures can be successfully repeated for recurrences, achieving healing rates of over 90%&#xD;
        for 1-2 interventions. Future well-designed trials are necessary to aid patient selection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>Rate of recurrence</measure>
      <time_frame>In about 6 month follow up</time_frame>
      <description>Showing each of both procedures efficacy in decreasing rate of recurrence of PNS</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2</enrollment>
    <condition>Pilonidal Sinus</condition>
    <arm_group>
      <arm_group_label>Wide local excision of pilonidal sinus</arm_group_label>
    </arm_group>
    <arm_group>
      <arm_group_label>Minimal excision of pilonidal sinus</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Z plasty and minimal excision of pilonidal sinus</intervention_name>
      <description>The investigators will perform a &quot; Z plasty &quot; procedure and Minimal excision procedure for patients complaining of pilonidal sinus and the investigators will compare the outcomes and rate of recurrence of these two procedures</description>
      <arm_group_label>Minimal excision of pilonidal sinus</arm_group_label>
      <arm_group_label>Wide local excision of pilonidal sinus</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Healthy people of both genders with or without history of PNS procedures before&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients complaining of primary PNS and Recurrent PNS following Minimal excision&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Recurrent PNS following wide local excision&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Abanoub emad fayez</investigator_full_name>
      <investigator_title>Resident doctor in Assiut university hospitals</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>
  
  
text: 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/NCT06021392
  org study id: Techniques of PNS excision
  nct id: NCT06021392
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Comparative study between wide local excision and minimal excision of pilonidal sinus
  Pilonidal sinus (PNS) disease is distributed in young adults who are supposed to be healthy
        with maximum productivity. Wide local excision creates a tissue gap, while the concept of
        minimal excision preserves healthy tissues with minimal tissue gap.
  
        Pilonidal disease is a frequent suppurative condition that occurs twice as often in men as in
        women, usually between the ages of 15 and 30. Pilonidal disease is located beneath the skin
        of the sacro-coccygeal region. It presents acutely as an abscess under tension while the
        chronic form gives rise to intermittent discharge from pilonidal sinus(es). Diagnosis is
        clinical and usually straightforward. In the large majority of cases, treatment is surgical
        but there is no consensus as to the 'ideal' technique. Acute abscess must be evacuated and an
        off-midline incision seems preferable. Excision is the standard definitive treatment but the
        choice of wide versus limited excision on the school of thought. Minimal excision or
        debridement of the sinus and/or cavity through a midline or a separate paramedian excision
        can also be performed, leaving the wounds open or closed. These methods are simple and
        cost-efficient, and associated with low pain, rapid healing, and a rapid return to normal
        activity. A disadvantage is the higher recurrence rate; however, these methods can be used
        repeatedly for recurrences. Although recurrence rates seem high at first glance, the
        procedures can be successfully repeated for recurrences, achieving healing rates of over 90%
        for 1-2 interventions. Future well-designed trials are necessary to aid patient selection.
  observational model: Case-Only
  time perspective: Prospective
  measure: Rate of recurrence
  time frame: In about 6 month follow up
  description: Showing each of both procedures efficacy in decreasing rate of recurrence of PNS
  arm group label: Wide local excision of pilonidal sinus
  arm group label: Minimal excision of pilonidal sinus
  intervention type: Procedure
  intervention name: Z plasty and minimal excision of pilonidal sinus
  description: The investigators will perform a " Z plasty " procedure and Minimal excision procedure for patients complaining of pilonidal sinus and the investigators will compare the outcomes and rate of recurrence of these two procedures
  arm group label: Minimal excision of pilonidal sinus
  arm group label: Wide local excision of pilonidal sinus
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor-Investigator
  investigator affiliation: Assiut University
  investigator full name: Abanoub emad fayez
  investigator title: Resident doctor in Assiut university hospitals
  mesh term: Pilonidal Sinus