<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/NCT04497337</url>
  </required_header>
  <id_info>
    <org_study_id>18630159</org_study_id>
    <nct_id>NCT04497337</nct_id>
  </id_info>
  <brief_title>The Superficial Lesions in the Peri-auricular Region</brief_title>
  <official_title>The Superficial Lesions in the Peri-auricular Region; Retrospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohammed Elrabie Ahmed</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</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>
      Superficial lesions on and around the ear are uncommon with many differential diagnoses and&#xD;
      different characteristic histopathologic features. The purpose of this study was to describe&#xD;
      a series of peri-auricular superficial lesions and characterize the distinctive types of&#xD;
      these lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data included in this descriptive retrospective study were collected from records of 70&#xD;
      patients with superficial lesions around the auricle, i.e., periauricular (preauricular,&#xD;
      auricular, and postauricular) during the period extending between 2017 and 2019, who were&#xD;
      primarily diagnosed and operated. Data were retrieved, reviewed, and analyzed. The primary&#xD;
      analysis outcome measures were patient history (age, gender, complaint, medical advice&#xD;
      clinic, and associated medical diseases), lesions examination (site, laterality, clinical&#xD;
      presentation, and the number of lesions). Also, the needed investigations for diagnosis, type&#xD;
      of intervention, postoperative patient satisfaction were evaluated. Evaluation of the&#xD;
      patients' follow up was done.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 12, 2019</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">May 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical and Histopathlogical types of superficial lesion around the ear</measure>
    <time_frame>Cases operated between in the previous 3 years from 2017 and 2019</time_frame>
  </primary_outcome>
  <enrollment type="Actual">70</enrollment>
  <condition>Superficial Cyst or Mass and Sinus on and Around the Ear</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Complete excision to superficial lesions around the ear</intervention_name>
    <description>Complete excision of these lesions and histopathology</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with superficial lesions around the auricle, i.e., periauricular&#xD;
             (preauricular, auricular, and postauricular) operated during the period extending&#xD;
             between 2017 and 2019&#xD;
&#xD;
          -  Available full demographic, clinical and histopathological data&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  deep lesions involving parotid or parapharyngeal space&#xD;
&#xD;
          -  Missed demographic, clinical and histopathological data&#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>Sohag University hospital</last_name>
    <role>Study Director</role>
    <affiliation>Nasr City, Eastern Avenue, University Street, Sohag, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sohag University</name>
      <address>
        <city>Sohag</city>
        <zip>82524</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>Mohammed Elrabie Ahmed</investigator_full_name>
    <investigator_title>Clinical Professor of Otolarygology head and neck surgery</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04497337
org study id: 18630159
nct id: NCT04497337
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Superficial lesions on and around the ear are uncommon with many differential diagnoses and
      different characteristic histopathologic features. The purpose of this study was to describe
      a series of peri-auricular superficial lesions and characterize the distinctive types of
      these lesions.
Data included in this descriptive retrospective study were collected from records of 70
      patients with superficial lesions around the auricle, i.e., periauricular (preauricular,
      auricular, and postauricular) during the period extending between 2017 and 2019, who were
      primarily diagnosed and operated. Data were retrieved, reviewed, and analyzed. The primary
      analysis outcome measures were patient history (age, gender, complaint, medical advice
      clinic, and associated medical diseases), lesions examination (site, laterality, clinical
      presentation, and the number of lesions). Also, the needed investigations for diagnosis, type
      of intervention, postoperative patient satisfaction were evaluated. Evaluation of the
      patients' follow up was done.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated
primary purpose: Treatment
masking: None (Open Label)
measure: clinical and Histopathlogical types of superficial lesion around the ear
time frame: Cases operated between in the previous 3 years from 2017 and 2019
intervention type: Procedure
intervention name: Complete excision to superficial lesions around the ear
description: Complete excision of these lesions and histopathology
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sohag University hospital
role: Study Director
affiliation: Nasr City, Eastern Avenue, University Street, Sohag, Egypt
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Sohag University
investigator full name: Mohammed Elrabie Ahmed
investigator title: Clinical Professor of Otolarygology head and neck surgery
sharing ipd: Undecided