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/NCT06010316</url>
    </required_header>
    <id_info>
      <org_study_id>TR-surgical treatment of CRS</org_study_id>
      <nct_id>NCT06010316</nct_id>
    </id_info>
    <brief_title>A Prospective Single-center Cohort Study of Surgical Treatment of Chronic Rhinosinusitis</brief_title>
    <official_title>A Prospective Single-center Cohort Study of Surgical Treatment of Chronic Rhinosinusitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Tongren Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beijing Tongren Hospital</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>
        Chronic Rhinosinusitis (CRS) is a common and frequent disease in otorhinolaryngology. The&#xD;
        main symptoms of patients include nasal congestion, runny nose, swelling pain of the frontal&#xD;
        area and decreased sense of smell. Chronic rhinosinusitis refers to chronic rhinosinusitis&#xD;
        with symptoms lasting ≥12 weeks and can be divided into two subgroups: chronic rhinosinusitis&#xD;
        with and without nasal polyps. Chronic rhinosinusitis has a complex pathogenesis, there are&#xD;
        three main pathogenic factors: infection, allergy and nasal and sinus anatomic abnormalities,&#xD;
        these factors are often not a single existence, but often intertwined. In addition,&#xD;
        environmental factors, genetic factors, osteitis, gastroesophageal reflux disease,&#xD;
        respiratory ciliary system defects, systemic immune dysfunction and other secondary risk&#xD;
        factors.&#xD;
  &#xD;
        For patients with chronic sinusitis, these symptoms, such as nasal congestion, runny nose,&#xD;
        swelling pain and decreased sense of smell, often seriously affect their quality of life, and&#xD;
        even evolve into more serious complications as the disease progresses. At present, the&#xD;
        conventional treatment methods mainly include drug conservative treatment and nasal&#xD;
        endoscopic surgery. Functional nasal endoscopic sinus surgery (FESS) is the main method of&#xD;
        further surgical treatment for patients with no obvious effect of drug treatment. In FESS,&#xD;
        the current emphasis is on removing diseased tissue and restoring sinus drainage on the&#xD;
        premise of preserving the normal mucosa and physiological structure of the nasal and nasal&#xD;
        sinuses as much as possible.&#xD;
  &#xD;
        Up to now, there have been many studies on surgical treatment of CRS, and the quality of the&#xD;
        studies varies. However, in view of the postoperative efficacy and long-term prognosis of&#xD;
        different subtypes of CRS, different treatment methods during surgery and different drug&#xD;
        therapy regimens, our research group believes that it is necessary to accumulate a large&#xD;
        amount of clinical data support through in-depth research and comprehensive analysis. Thus&#xD;
        more reliable conclusions can be drawn. In this study, patients undergoing CRS surgery in the&#xD;
        research ward of the Department of rhinosinusitis will be actively included through a&#xD;
        prospective single-center cohort study to provide evidence for evidence-based medicine and&#xD;
        better guide clinical rhinologists to make surgical treatment decisions for patients with&#xD;
        chronic rhinosinusitis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The change in Total Nasal Symptom Score (TNSS).</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>TNSS is used to assess the severity of nasal symptoms (runny nose, nasal congestion, hyposmia, sneezing): 0 = asymptomatic; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms. The sum of the scores of each symptom is used as the TNSS.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The changes in VAS score.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>The visual Analogue Scale (VAS) can be used to assess symptom severity, with a score of 0 representing no distress and a score of 10 representing the most severe distress imaginable. 0~2 was classified as mild, 3~7 as moderate, 8~10 as severe. A score above 5 indicates an impact on quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in SNOT-22 score.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>The 22-item Sino-nasal outcome test (SNOT-22) was used to evaluate the changes in symptoms of patients. According to the severity of symptoms caused by RCRS, each item was divided into 6 levels: 0 = no distress ,1 = mild distress, 2 = mild distress, 3 = moderate distress, 4 = severe distress, 5 = very severe distress. The higher the score, the more severe the symptoms, and the final total score of the item is counted.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in asthma ACQ score.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>For patients with asthma, we assessed the change of asthma symptoms through the Asthma Control Questionnaire (ACQ). Each question was scored on a scale of 0 to 6 according to the severity. The result score of each item was averaged. A score of &lt;0.75 indicated that the asthma had been completely controlled; a score of 0.75-1.5 indicates well-controlled asthma; a score of &gt;1.5 indicates that asthma is not controlled.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in Nasal Polyp Score (NPS) score.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>Bilateral polyp volume size described using the NPS (0 - 4 points per side: 0 = no polyp; 1 = small polyp in the middle meatus, not reaching the inferior border of the middle turbinate; 2 = small polyp in the middle meatus, reaching the inferior border of the middle turbinate; 3 = large polyp protruding from the middle meatus, not reaching the inferior border of the inferior turbinate; 4 = large polyp that almost causes most or complete obstruction of the nasal cavity).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in sinus CT score.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>The Lund-Mackay imaging scoring system was used for the CT scan results of the sinuses (0, 1, and 2 were used for each frontal sinus, anterior ethmoid sinus, posterior ethmoid sinus, maxillary sinus, and sphenoid sinus, indicating no opacity, partial opacity and all turbidity of the sinus cavity respectively; 0 and 2 were used for each side of the sinus complex to indicate no blockage and presence of blockage) to calculate the total score and E/M value (bilateral ethmoid total score/bilateral maxillary sinus total score), etc.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in olfactory symptom score.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of eosinophils in peripheral blood</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>The changes of eosinophils in peripheral blood were different from pre-operation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of IgE in peripheral blood.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>The changes of IgE in peripheral blood were different from pre-operation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes in biomarkers in nasal exfoliated cells and nasal secretion swabs.</measure>
      <time_frame>Pre-operation, 1 year after surgery</time_frame>
      <description>Changes in expression levels of T1, T2, T3 factors and T2 inflammatory markers CST1 and CLC in nasal brush exfoliated cells and nasal secretions.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Chronic Rhinosinusitis (Diagnosis)</condition>
    <condition>Cohort Study</condition>
    <condition>Evidence-based Medicine</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with chronic sinusitis in the research ward of the Department of Rhinology,&#xD;
          Beijing Tongren Hospital, Capital Medical University.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  (1) Meeting the CRS diagnostic criteria in the Chinese Guidelines for the Diagnosis&#xD;
               and Treatment of Chronic Sinusitis (2018); (2) The effect of conservative drug&#xD;
               treatment is not good or there are indications of surgery; (3) Good compliance, able&#xD;
               to complete clinical observation. Compliance with guidelines&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  (1) The patient has conditions or co-existing diseases that may preclude the primary&#xD;
               efficacy endpoint evaluation, such as benign or malignant tumors of the nasal cavity;&#xD;
               (2) Clinically significant co-existing diseases that may interfere with clinical&#xD;
               efficacy results, including but not limited to: Cystic fibrosis, eosinophilic&#xD;
               granuloma with polyvasculitis (Churg-Strauss syndrome), granuloma with polyvasculitis&#xD;
               (Wegener's granuloma), Young's synthesis, tuberculosis or other pathogen infection,&#xD;
               malignancy, etc. (3) The patient had other medical or non-medical conditions that the&#xD;
               investigator considered unsuitable for participation in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Beijing Tongren Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luo Zhang, M.D.</last_name>
        <phone>(86)13910830399</phone>
        <email>dr.luozhang@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Luo Zhang</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sinusitis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06010316
  org study id: TR-surgical treatment of CRS
  nct id: NCT06010316
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Chronic Rhinosinusitis (CRS) is a common and frequent disease in otorhinolaryngology. The
        main symptoms of patients include nasal congestion, runny nose, swelling pain of the frontal
        area and decreased sense of smell. Chronic rhinosinusitis refers to chronic rhinosinusitis
        with symptoms lasting ≥12 weeks and can be divided into two subgroups: chronic rhinosinusitis
        with and without nasal polyps. Chronic rhinosinusitis has a complex pathogenesis, there are
        three main pathogenic factors: infection, allergy and nasal and sinus anatomic abnormalities,
        these factors are often not a single existence, but often intertwined. In addition,
        environmental factors, genetic factors, osteitis, gastroesophageal reflux disease,
        respiratory ciliary system defects, systemic immune dysfunction and other secondary risk
        factors.
  
        For patients with chronic sinusitis, these symptoms, such as nasal congestion, runny nose,
        swelling pain and decreased sense of smell, often seriously affect their quality of life, and
        even evolve into more serious complications as the disease progresses. At present, the
        conventional treatment methods mainly include drug conservative treatment and nasal
        endoscopic surgery. Functional nasal endoscopic sinus surgery (FESS) is the main method of
        further surgical treatment for patients with no obvious effect of drug treatment. In FESS,
        the current emphasis is on removing diseased tissue and restoring sinus drainage on the
        premise of preserving the normal mucosa and physiological structure of the nasal and nasal
        sinuses as much as possible.
  
        Up to now, there have been many studies on surgical treatment of CRS, and the quality of the
        studies varies. However, in view of the postoperative efficacy and long-term prognosis of
        different subtypes of CRS, different treatment methods during surgery and different drug
        therapy regimens, our research group believes that it is necessary to accumulate a large
        amount of clinical data support through in-depth research and comprehensive analysis. Thus
        more reliable conclusions can be drawn. In this study, patients undergoing CRS surgery in the
        research ward of the Department of rhinosinusitis will be actively included through a
        prospective single-center cohort study to provide evidence for evidence-based medicine and
        better guide clinical rhinologists to make surgical treatment decisions for patients with
        chronic rhinosinusitis.
  observational model: Cohort
  time perspective: Prospective
  measure: The change in Total Nasal Symptom Score (TNSS).
  time frame: Pre-operation, 1 year after surgery
  description: TNSS is used to assess the severity of nasal symptoms (runny nose, nasal congestion, hyposmia, sneezing): 0 = asymptomatic; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms. The sum of the scores of each symptom is used as the TNSS.
  measure: The changes in VAS score.
  time frame: Pre-operation, 1 year after surgery
  description: The visual Analogue Scale (VAS) can be used to assess symptom severity, with a score of 0 representing no distress and a score of 10 representing the most severe distress imaginable. 0~2 was classified as mild, 3~7 as moderate, 8~10 as severe. A score above 5 indicates an impact on quality of life.
  measure: The changes in SNOT-22 score.
  time frame: Pre-operation, 1 year after surgery
  description: The 22-item Sino-nasal outcome test (SNOT-22) was used to evaluate the changes in symptoms of patients. According to the severity of symptoms caused by RCRS, each item was divided into 6 levels: 0 = no distress ,1 = mild distress, 2 = mild distress, 3 = moderate distress, 4 = severe distress, 5 = very severe distress. The higher the score, the more severe the symptoms, and the final total score of the item is counted.
  measure: The changes in asthma ACQ score.
  time frame: Pre-operation, 1 year after surgery
  description: For patients with asthma, we assessed the change of asthma symptoms through the Asthma Control Questionnaire (ACQ). Each question was scored on a scale of 0 to 6 according to the severity. The result score of each item was averaged. A score of <0.75 indicated that the asthma had been completely controlled; a score of 0.75-1.5 indicates well-controlled asthma; a score of >1.5 indicates that asthma is not controlled.
  measure: The changes in Nasal Polyp Score (NPS) score.
  time frame: Pre-operation, 1 year after surgery
  description: Bilateral polyp volume size described using the NPS (0 - 4 points per side: 0 = no polyp; 1 = small polyp in the middle meatus, not reaching the inferior border of the middle turbinate; 2 = small polyp in the middle meatus, reaching the inferior border of the middle turbinate; 3 = large polyp protruding from the middle meatus, not reaching the inferior border of the inferior turbinate; 4 = large polyp that almost causes most or complete obstruction of the nasal cavity).
  measure: The changes in sinus CT score.
  time frame: Pre-operation, 1 year after surgery
  description: The Lund-Mackay imaging scoring system was used for the CT scan results of the sinuses (0, 1, and 2 were used for each frontal sinus, anterior ethmoid sinus, posterior ethmoid sinus, maxillary sinus, and sphenoid sinus, indicating no opacity, partial opacity and all turbidity of the sinus cavity respectively; 0 and 2 were used for each side of the sinus complex to indicate no blockage and presence of blockage) to calculate the total score and E/M value (bilateral ethmoid total score/bilateral maxillary sinus total score), etc.
  measure: The changes in olfactory symptom score.
  time frame: Pre-operation, 1 year after surgery
  measure: The changes of eosinophils in peripheral blood
  time frame: Pre-operation, 1 year after surgery
  description: The changes of eosinophils in peripheral blood were different from pre-operation.
  measure: The changes of IgE in peripheral blood.
  time frame: Pre-operation, 1 year after surgery
  description: The changes of IgE in peripheral blood were different from pre-operation.
  measure: The changes in biomarkers in nasal exfoliated cells and nasal secretion swabs.
  time frame: Pre-operation, 1 year after surgery
  description: Changes in expression levels of T1, T2, T3 factors and T2 inflammatory markers CST1 and CLC in nasal brush exfoliated cells and nasal secretions.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Sinusitis
  sharing ipd: No