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/NCT05979662</url>
    </required_header>
    <id_info>
      <org_study_id>34417/1/21</org_study_id>
      <nct_id>NCT05979662</nct_id>
    </id_info>
    <brief_title>Endoscopic Frontal Sinus Surgery Draf III in Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps</brief_title>
    <official_title>Clinical Evaluation of Primary Endoscopic Frontal Sinus Surgery Grade 6 (Draf III) in Patients With Moderate to Severe Eosinophilic Chronic Rhinosinusitis With Polyps</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ibrahim Talal Elshamy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tanta University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus&#xD;
        surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic&#xD;
        rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using&#xD;
        endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and&#xD;
        need for corticosteroid to control polyp postoperatively.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder,&#xD;
        affecting about 4% of the population worldwide and strongly impacts the quality of life of&#xD;
        affected patient.&#xD;
  &#xD;
        Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic&#xD;
        rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil &gt;10 cells per&#xD;
        high power field (HPF), have worse disease severity and poorer treatment outcomes compared to&#xD;
        non-Eosinophilic chronic rhinosinusitis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrence of polyp using endoscopic polyp score</measure>
      <time_frame>One year postoperatively</time_frame>
      <description>Polyps were evaluated on each side through nasal endoscopy at each visit and graded based on polyp size, resulting in scores of 0 to 4 9. Zero is no polyp, 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = polyps reaching below the lower border of the middle turbinate, 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = large polyps causing complete obstruction of the inferior nasal cavity. The sum of the left and right nostril scores is the Nasal Polyp Score</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lund MacKay score</measure>
      <time_frame>One year postoperatively</time_frame>
      <description>The Lund-Mackay staging system scores each sinus (anterior ethmoid, posterior ethmoid, maxillary, frontal, and sphenoid sinuses) according to the following scale: 0 (no opacification), 1 (partial opacification), or 2 (complete opacification).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sinonasal Outcome Test- 22</measure>
      <time_frame>One year postoperatively</time_frame>
      <description>SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Endoscopic Frontal Sinus Surgery</condition>
    <condition>Chronic Rhinosinusitis With Nasal Polyps</condition>
    <condition>Draf III</condition>
    <condition>Draf I or IIa</condition>
    <arm_group>
      <arm_group_label>Group one</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group two</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic frontal sinus surgery grade 6(Draf III).</intervention_name>
      <description>Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).</description>
      <arm_group_label>Group one</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)</intervention_name>
      <description>Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).</description>
      <arm_group_label>Group two</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          • Patients with moderate or severe eosinophilic chronic rhinosinusitis with polyps who&#xD;
          failed appropriate medical treatment in the form of antibiotic, systemic and local&#xD;
          corticosteroid for 3 months .&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Narrow anteroposterior diameter of frontal sinus ostium(1cm or less)&#xD;
  &#xD;
            -  Patients showing less or highest degree of radiological complexity of surgery on&#xD;
               studying the Computed Tomography.&#xD;
  &#xD;
            -  Any contraindication for general anesthesia.&#xD;
  &#xD;
            -  Patients below age of 18 years.&#xD;
  &#xD;
            -  Incomplete follow up&#xD;
  &#xD;
            -  previous sinus surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Ibrahim T Elshamy, MSc</last_name>
      <phone>+20 102 237 3920</phone>
      <email>hematalal93@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Tanta University Hospitals</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <zip>31511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ibrahim T Elshamy</last_name>
        <phone>+201022373920</phone>
        <email>hematalal93@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Mohammed H Hamad, Prof</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Mohammed H Askar, Prof</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Tanta University</name>
        <address>
          <city>Tanta</city>
          <state>El-Gharbia</state>
          <zip>31511</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ibrahim T Elshamy</last_name>
        <phone>+201022373920</phone>
        <email>hematalal93@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Mohammed H Hamad, Prof</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>July 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 29, 2023</last_update_submitted>
    <last_update_submitted_qc>July 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Tanta University</investigator_affiliation>
      <investigator_full_name>Ibrahim Talal Elshamy</investigator_full_name>
      <investigator_title>Assistant Lecturer of Otorhinolaryngology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sinusitis</mesh_term>
      <mesh_term>Nasal Polyps</mesh_term>
      <mesh_term>Polyps</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The data will be available upon a reasonable request from the corresponding author after the end of study for one year.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>after the end of study for one year.</ipd_time_frame>
      <ipd_access_criteria>The data will be available upon a reasonable request from the corresponding autho</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05979662
  org study id: 34417/1/21
  nct id: NCT05979662
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to evaluate the effect of the primary endoscopic frontal sinus
        surgery on the clinical outcome in patients having moderate to severe eosinophilic chronic
        rhinosinusitis with polyps with primary outcome measures in form of recurrence of polyp using
        endoscopic polyp score and Secondary outcome measures include Lund MacKay score, SNOT-22 and
        need for corticosteroid to control polyp postoperatively.
  Chronic rhinosinusitis with nasal polyps (CRSwNP) is a common inflammatory disorder,
        affecting about 4% of the population worldwide and strongly impacts the quality of life of
        affected patient.
  
        Eosinophilic chronic rhinosinusitis (ECRS) is a subtype of recalcitrant Chronic
        rhinosinusitis . Patients with ECRS and generally having a tissue eosinophil >10 cells per
        high power field (HPF), have worse disease severity and poorer treatment outcomes compared to
        non-Eosinophilic chronic rhinosinusitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Recurrence of polyp using endoscopic polyp score
  time frame: One year postoperatively
  description: Polyps were evaluated on each side through nasal endoscopy at each visit and graded based on polyp size, resulting in scores of 0 to 4 9. Zero is no polyp, 1 = small polyps in the middle meatus not reaching below the inferior border of the middle turbinate, 2 = polyps reaching below the lower border of the middle turbinate, 3 = large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle turbinate, and 4 = large polyps causing complete obstruction of the inferior nasal cavity. The sum of the left and right nostril scores is the Nasal Polyp Score
  measure: Lund MacKay score
  time frame: One year postoperatively
  description: The Lund-Mackay staging system scores each sinus (anterior ethmoid, posterior ethmoid, maxillary, frontal, and sphenoid sinuses) according to the following scale: 0 (no opacification), 1 (partial opacification), or 2 (complete opacification).
  measure: Sinonasal Outcome Test- 22
  time frame: One year postoperatively
  description: SNOT- 22 was measured based on a 0-5 scale, where 0 defines no problems with the given symptom and 5 defines maximal problems
  arm group label: Group one
  arm group type: Experimental
  description: Patients will undergo endoscopic frontal sinus surgery grade 6(Draf III).
  arm group label: Group two
  arm group type: Active Comparator
  description: Patients will undergo endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
  intervention type: Procedure
  intervention name: Endoscopic frontal sinus surgery grade 6(Draf III).
  description: Patients will receive endoscopic frontal sinus surgery grade 6(Draf III).
  arm group label: Group one
  intervention type: Procedure
  intervention name: Endoscopic frontal sinus surgery grade 1-3(Draf I or IIa)
  description: Patients will receive endoscopic frontal sinus surgery grade 1-3(Draf I or IIa).
  arm group label: Group two
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ibrahim T Elshamy, MSc
  phone: +20 102 237 3920
  email: hematalal93@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Tanta University
  investigator full name: Ibrahim Talal Elshamy
  investigator title: Assistant Lecturer of Otorhinolaryngology
  mesh term: Sinusitis
  mesh term: Nasal Polyps
  mesh term: Polyps
  sharing ipd: Yes
  ipd description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
  ipd info type: Study Protocol
  ipd time frame: after the end of study for one year.
  ipd access criteria: The data will be available upon a reasonable request from the corresponding autho