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/NCT05989919</url>
    </required_header>
    <id_info>
      <org_study_id>538-2022</org_study_id>
      <nct_id>NCT05989919</nct_id>
    </id_info>
    <brief_title>Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps</brief_title>
    <official_title>Nasal Anatomical and Pathological Variants in Patients With Antrochoanal Polyps</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Minia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Minia 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>
        The goal of this observational study is to learn about anatomical and pathological variants&#xD;
        in patients with antrochoanal polyps trying to find a key to its pathogenesis Participants&#xD;
        will have nasal endoscopic examination and CT nose and paranasal sinuses.&#xD;
  &#xD;
        we will compare patients with antrochoanal polyps and other patients with unilateral&#xD;
        sinonasal disease regarding anatomical and pathological variants.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study was conducted at Otolaryngology department, Minia University Hospital, Minia,&#xD;
        Egypt. The study was approved by the Institutional Review Board at Minia University.&#xD;
  &#xD;
        The study participants were recruited from patients complaining from unilateral sinonasal&#xD;
        disease attending outpatient clinic.&#xD;
  &#xD;
        we selected 40 patients with ACPs who had the following inclusion criteria: 1-radiologically&#xD;
        diagnosed based on CT nose and PNS. 2-histopathologically diagnosed as ACP. The radiological&#xD;
        diagnosis is based on seeing low attenuated soft tissue mass filling the maxillary antrum and&#xD;
        extending through the middle meatus into the nasal cavity and directs towards the post nasal&#xD;
        opening. We excluded: 1- patients with history of maxillofacial trauma. 2- patients who had&#xD;
        previous nasal surgery.&#xD;
  &#xD;
        To be more objective, a control group of 40 patients who had unilateral sinonasal disease&#xD;
        other than ACP was formed.&#xD;
  &#xD;
        We assessed multislice computed tomography (CT) nose and paranasal sinus images by Toshiba&#xD;
        aquilion CT scanner. Axial and coronal 250mm cuts were obtained.&#xD;
  &#xD;
        Both study and control groups were compared regarding anatomical and pathological variations&#xD;
        in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical&#xD;
        middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or&#xD;
        middle turbinate). We also compare between them according to presence of retention cyst in CT&#xD;
        in contralateral side In the cases with deviated nasal septum, the septal deviation was seen&#xD;
        if it is towards the side of the lesion or towards the opposite side according to its&#xD;
        convexity.&#xD;
  &#xD;
        We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an&#xD;
        indication of chronic inflammation.&#xD;
  &#xD;
        SPSS 24.0 program was used for statistical analysis. Averages and standard deviations were&#xD;
        calculated. The Mann-Whitney and Chi square tests were used for comparisons between the&#xD;
        groups. The Pearson correlation tests was used to evaluate correlations. Statistical&#xD;
        significance was set at ≤ 0.05.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Suspended</overall_status>
    <why_stopped>
      to see how the study is going&#xD;
    </why_stopped>
    <start_date type="Actual">December 20, 2022</start_date>
    <completion_date type="Anticipated">August 2023</completion_date>
    <primary_completion_date type="Actual">July 30, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <target_duration>1 Month</target_duration>
    <primary_outcome>
      <measure>presence of anatomical and pathological variants in CT scan and endoscopic examination</measure>
      <time_frame>6 months</time_frame>
      <description>Both study and control groups were compared regarding anatomical and pathological variations in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or middle turbinate). We also compare between them according to presence of retention cyst in CT in contralateral side In the cases with deviated nasal septum, the septal deviation was seen if it is towards the side of the lesion or towards the opposite side according to its convexity.&#xD;
  We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an indication of chronic inflammation.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Antrochoanal Polyp</condition>
    <arm_group>
      <arm_group_label>study group</arm_group_label>
      <description>patients with antrochoanal polyps</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <description>patients with unilateral sinonasal disease other than antrochoanal polyps</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CT scan for nose and paranasal sinuses</intervention_name>
      <description>CT scan for nose and paranasal sinuses</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>study group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study participants were recruited from patients complaining from unilateral sinonasal&#xD;
          disease attending our outpatient clinic.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. radiologically diagnosed based on CT nose and PNS.&#xD;
  &#xD;
            2. histopathologically diagnosed as ACP.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with history of maxillofacial trauma.&#xD;
  &#xD;
            2. patients who had previous nasal surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Faculty of Medicine</name>
        <address>
          <city>Minya</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Minia University</investigator_affiliation>
      <investigator_full_name>Maisara Mohamed</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>Nasal Polyps</mesh_term>
      <mesh_term>Polyps</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </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/NCT05989919
  org study id: 538-2022
  nct id: NCT05989919
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn about anatomical and pathological variants
        in patients with antrochoanal polyps trying to find a key to its pathogenesis Participants
        will have nasal endoscopic examination and CT nose and paranasal sinuses.
  
        we will compare patients with antrochoanal polyps and other patients with unilateral
        sinonasal disease regarding anatomical and pathological variants.
  This study was conducted at Otolaryngology department, Minia University Hospital, Minia,
        Egypt. The study was approved by the Institutional Review Board at Minia University.
  
        The study participants were recruited from patients complaining from unilateral sinonasal
        disease attending outpatient clinic.
  
        we selected 40 patients with ACPs who had the following inclusion criteria: 1-radiologically
        diagnosed based on CT nose and PNS. 2-histopathologically diagnosed as ACP. The radiological
        diagnosis is based on seeing low attenuated soft tissue mass filling the maxillary antrum and
        extending through the middle meatus into the nasal cavity and directs towards the post nasal
        opening. We excluded: 1- patients with history of maxillofacial trauma. 2- patients who had
        previous nasal surgery.
  
        To be more objective, a control group of 40 patients who had unilateral sinonasal disease
        other than ACP was formed.
  
        We assessed multislice computed tomography (CT) nose and paranasal sinus images by Toshiba
        aquilion CT scanner. Axial and coronal 250mm cuts were obtained.
  
        Both study and control groups were compared regarding anatomical and pathological variations
        in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical
        middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or
        middle turbinate). We also compare between them according to presence of retention cyst in CT
        in contralateral side In the cases with deviated nasal septum, the septal deviation was seen
        if it is towards the side of the lesion or towards the opposite side according to its
        convexity.
  
        We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an
        indication of chronic inflammation.
  
        SPSS 24.0 program was used for statistical analysis. Averages and standard deviations were
        calculated. The Mann-Whitney and Chi square tests were used for comparisons between the
        groups. The Pearson correlation tests was used to evaluate correlations. Statistical
        significance was set at ≤ 0.05.
  observational model: Other
  time perspective: Other
  measure: presence of anatomical and pathological variants in CT scan and endoscopic examination
  time frame: 6 months
  description: Both study and control groups were compared regarding anatomical and pathological variations in the nose. These variants include: deviated nasal septum, concha bullosa, paradoxical middle turbinate and uncinate process insertion (to lamina papyrecea or roof of ethmoid or middle turbinate). We also compare between them according to presence of retention cyst in CT in contralateral side In the cases with deviated nasal septum, the septal deviation was seen if it is towards the side of the lesion or towards the opposite side according to its convexity.
  We also evaluate the sclerosis on thickening of the bony wall of the para nasal sinus as an indication of chronic inflammation.
  arm group label: study group
  description: patients with antrochoanal polyps
  arm group label: control group
  description: patients with unilateral sinonasal disease other than antrochoanal polyps
  intervention type: Other
  intervention name: CT scan for nose and paranasal sinuses
  description: CT scan for nose and paranasal sinuses
  arm group label: control group
  arm group label: study group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Minia University
  investigator full name: Maisara Mohamed
  investigator title: assistant lecturer of otorhinolaryngology
  mesh term: Nasal Polyps
  mesh term: Polyps
  sharing ipd: Undecided