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/NCT05991024</url>
    </required_header>
    <id_info>
      <org_study_id>HuadongHosptialHernia</org_study_id>
      <nct_id>NCT05991024</nct_id>
    </id_info>
    <brief_title>Pulmonary Ventilation Function Between Patients With Primary and Recurrent Incisional Hernia: a Cross-sectional Study</brief_title>
    <official_title>Pulmonary Ventilation Function Between Patients With Primary and Recurrent Incisional Hernia: a Cross-sectional Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan 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>
        Purpose Chronic obstructive pulmonary disease (COPD) is a risk factor for incisional hernia,&#xD;
        COPD has persistent airflow restriction and pulmonary ventilation dysfunction. The aim of&#xD;
        this study was to compare differences in pulmonary ventilation function between primary&#xD;
        incisional hernia and recurrent incisional hernia.&#xD;
  &#xD;
        Method According to the inclusion and exclusion criteria,Patients diagnosed with &quot;incisional&#xD;
        hernia&quot; in our hospital's electronic medical record system were divided into two groups:&#xD;
        primary group and recurrent group based on whether the incisional hernia recurred after&#xD;
        incisional hernia repair,who were screened out with abdominal wall incisional hernia.The&#xD;
        patient information of the two groups were collected, examined and recorded.The clinical data&#xD;
        was analyzed by using statistical analysis software.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Method Study design and patient population： This study is a single-center cross-sectional&#xD;
        study. The main steps of this study are patients search, information review, data record,&#xD;
        data verification and statistical analysis.&#xD;
  &#xD;
        The investigators searched the electronic medical record system from January 2016 to March&#xD;
        2023, using the 10th edition of the International Classification of Diseases (ICD-10).&#xD;
  &#xD;
        Inclusion and exclusion criteria The investigators reviewed the physical examination records&#xD;
        of each patient, combined with abdominal CT images, only patients diagnosed with &quot;abdominal&#xD;
        incisional hernia&quot; were included in our study, patients with other types of abdominal&#xD;
        external hernia, such as parastomal hernias and umbilical hernias, were excluded.&#xD;
  &#xD;
        CT imagings of the abdomen and pulmonary function tests were two required items. Patients&#xD;
        with incomplete data were excluded, patients with complete data were included in the study&#xD;
        and were divided into two groups: primary group and recurrent group depends on whether there&#xD;
        is a recurrence.&#xD;
  &#xD;
        Because primary incisional hernia may turn into recurrence. To reduce error, patients with&#xD;
        primary incisional hernia less than one year when the study was started were excluded, the&#xD;
        investigators conducted telephone follow-up of patients with primary incisional hernia.&#xD;
        Recurrence after repair was the main outcome, patients with follow-up results of&#xD;
        non-recurrence were included in the study. Patients who have recurrent require reassessment&#xD;
        of pulmonary function, the patients with missing pulmonary function are excluded.&#xD;
  &#xD;
        The search was carried out by two researchers who extracted data independently and the&#xD;
        results were double-checked; Diagnosis is done independently by two experienced surgeons,&#xD;
        based on medical history and CT images. If there is disagreement, it will be determined after&#xD;
        discussion with a third experienced surgeon.&#xD;
  &#xD;
        Data Collection The investigators extracted the patient's age, gender, ethnicity, BMI,&#xD;
        abdominal CT image, maximum length of abdominal wall defect, hypertension, diabetes, coronary&#xD;
        heart disease and pulmonary function test report, pulmonary function test including pulmonary&#xD;
        ventilation function and pulmonary diffusion function, pulmonary ventilation function is the&#xD;
        main observation index of this study. The fixed threshold method often used in China to grade&#xD;
        pulmonary ventilation dysfunction[9], our hospital graded the severity of pulmonary&#xD;
        ventilation dysfunction with FEV1 as a percentage of the expected value: Mild: &gt;70%;&#xD;
        Moderate: 60%~69%; Moderate to severe: 50%~59%; Severe: 35%~49%; Very severe: &lt;35%. The&#xD;
        maximum length of the abdominal wall defect is measured using multi-slice helical CT 3D&#xD;
        reconstruction technology, which is performed by a radiologist.&#xD;
  &#xD;
        Statistical analysis Continuous variables that conform to a normal distribution are tested&#xD;
        using an independent sample t-test; Chi-square test and continuous correction chi-square test&#xD;
        are used for categorical variables; The grading variables use Wilcoxon's sum test. When&#xD;
        P&lt;0.05, the difference was considered statistically significant, and the statistical analysis&#xD;
        software used in this study was SPSS Version 20.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2023</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrent</measure>
      <time_frame>2016.1-2023.3</time_frame>
      <description>Recurrence after surgery repair</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">164</enrollment>
    <condition>Incisional Hernia</condition>
    <condition>Recurrent Hernia</condition>
    <condition>COPD</condition>
    <condition>Pulmonary Ventilation Function</condition>
    <arm_group>
      <arm_group_label>The primary group</arm_group_label>
      <description>Patients diagnosed with &quot;incisional hernia&quot; in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>The recurrent group</arm_group_label>
      <description>Patients diagnosed with &quot;incisional hernia&quot; in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>the incisional hernia recurrent</intervention_name>
      <description>Recurrence after repair was the main outcome</description>
      <arm_group_label>The recurrent group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          patients diagnosed with &quot;abdominal incisional hernia&quot;and complete data&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Abdominal incisional hernia&#xD;
  &#xD;
            -  Complete CT imagings of the abdomen and pulmonary function tests data&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Abdominal external hernia, such as parastomal hernias and umbilical hernias&#xD;
  &#xD;
            -  Primary incisional hernia less than one year when the study started&#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>Yiming Lin</name>
        <address>
          <city>Shanghai</city>
          <zip>000000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</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 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Zhijun Bao</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>Incisional Hernia</keyword>
    <keyword>Recurrent Hernia</keyword>
    <keyword>COPD</keyword>
    <keyword>Pulmonary ventilation function</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Hernia</mesh_term>
      <mesh_term>Incisional Hernia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>I have to make sure that the patient's privacy and rights are adequately protected</ipd_description>
    </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/NCT05991024
  org study id: HuadongHosptialHernia
  nct id: NCT05991024
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Purpose Chronic obstructive pulmonary disease (COPD) is a risk factor for incisional hernia,
        COPD has persistent airflow restriction and pulmonary ventilation dysfunction. The aim of
        this study was to compare differences in pulmonary ventilation function between primary
        incisional hernia and recurrent incisional hernia.
  
        Method According to the inclusion and exclusion criteria,Patients diagnosed with "incisional
        hernia" in our hospital's electronic medical record system were divided into two groups:
        primary group and recurrent group based on whether the incisional hernia recurred after
        incisional hernia repair,who were screened out with abdominal wall incisional hernia.The
        patient information of the two groups were collected, examined and recorded.The clinical data
        was analyzed by using statistical analysis software.
  Method Study design and patient population： This study is a single-center cross-sectional
        study. The main steps of this study are patients search, information review, data record,
        data verification and statistical analysis.
  
        The investigators searched the electronic medical record system from January 2016 to March
        2023, using the 10th edition of the International Classification of Diseases (ICD-10).
  
        Inclusion and exclusion criteria The investigators reviewed the physical examination records
        of each patient, combined with abdominal CT images, only patients diagnosed with "abdominal
        incisional hernia" were included in our study, patients with other types of abdominal
        external hernia, such as parastomal hernias and umbilical hernias, were excluded.
  
        CT imagings of the abdomen and pulmonary function tests were two required items. Patients
        with incomplete data were excluded, patients with complete data were included in the study
        and were divided into two groups: primary group and recurrent group depends on whether there
        is a recurrence.
  
        Because primary incisional hernia may turn into recurrence. To reduce error, patients with
        primary incisional hernia less than one year when the study was started were excluded, the
        investigators conducted telephone follow-up of patients with primary incisional hernia.
        Recurrence after repair was the main outcome, patients with follow-up results of
        non-recurrence were included in the study. Patients who have recurrent require reassessment
        of pulmonary function, the patients with missing pulmonary function are excluded.
  
        The search was carried out by two researchers who extracted data independently and the
        results were double-checked; Diagnosis is done independently by two experienced surgeons,
        based on medical history and CT images. If there is disagreement, it will be determined after
        discussion with a third experienced surgeon.
  
        Data Collection The investigators extracted the patient's age, gender, ethnicity, BMI,
        abdominal CT image, maximum length of abdominal wall defect, hypertension, diabetes, coronary
        heart disease and pulmonary function test report, pulmonary function test including pulmonary
        ventilation function and pulmonary diffusion function, pulmonary ventilation function is the
        main observation index of this study. The fixed threshold method often used in China to grade
        pulmonary ventilation dysfunction[9], our hospital graded the severity of pulmonary
        ventilation dysfunction with FEV1 as a percentage of the expected value: Mild: >70%;
        Moderate: 60%~69%; Moderate to severe: 50%~59%; Severe: 35%~49%; Very severe: <35%. The
        maximum length of the abdominal wall defect is measured using multi-slice helical CT 3D
        reconstruction technology, which is performed by a radiologist.
  
        Statistical analysis Continuous variables that conform to a normal distribution are tested
        using an independent sample t-test; Chi-square test and continuous correction chi-square test
        are used for categorical variables; The grading variables use Wilcoxon's sum test. When
        P<0.05, the difference was considered statistically significant, and the statistical analysis
        software used in this study was SPSS Version 20.
  observational model: Cohort
  time perspective: Retrospective
  measure: Recurrent
  time frame: 2016.1-2023.3
  description: Recurrence after surgery repair
  arm group label: The primary group
  description: Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia.
  arm group label: The recurrent group
  description: Patients diagnosed with "incisional hernia" in our hospital's electronic medical record system were divided into two groups: primary group and recurrent group based on whether the incisional hernia recurred after incisional hernia repair,who were screened out with abdominal wall incisional hernia.
  intervention type: Behavioral
  intervention name: the incisional hernia recurrent
  description: Recurrence after repair was the main outcome
  arm group label: The recurrent group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Zhijun Bao
  investigator title: Director
  mesh term: Recurrence
  mesh term: Hernia
  mesh term: Incisional Hernia
  sharing ipd: No
  ipd description: I have to make sure that the patient's privacy and rights are adequately protected