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/NCT06040606</url>
    </required_header>
    <id_info>
      <org_study_id>2023A-176</org_study_id>
      <nct_id>NCT06040606</nct_id>
    </id_info>
    <brief_title>Postoperative Complications and Mortality With In-Hospital COVID-19 Omicron Infection After Surgery</brief_title>
    <official_title>Tangdu Hospital, Air Force Medical University</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tang-Du Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tang-Du 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>
        Postoperative complications and mortality in patients with COVID-19 Omicron infection who&#xD;
        have undergone specialized thoracic surgery are scarce. Subsequently, the patient cohort was&#xD;
        divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who&#xD;
        acquired nosocomial omicron infection after surgery, and Group 2 (G2), which comprised&#xD;
        patients who remained uninfected with omicron during their hospitalization period. Propensity&#xD;
        score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27 to assess&#xD;
        the incidence of perioperative complications and mortality rates between both groups.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical&#xD;
        University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022,&#xD;
        and January 15, 2023, were collected. The data encompassed various clinical parameters,&#xD;
        including age, sex, medical history, smoking history, disease classification, the extent of&#xD;
        surgical resection, time of postoperative omicron diagnosis, duration of symptoms, COVID-19&#xD;
        classification (The symptoms of novel COVID-19 infection were classified as mild, medium,&#xD;
        severe and critical according to the diagnosis and treatment of novel COVID-19 infection&#xD;
        version 10), postoperative complications, and 30-day postoperative outcomes. Subsequently,&#xD;
        the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which&#xD;
        comprised patients who acquired nosocomial omicron infection after surgery, and Group 2 (G2),&#xD;
        which comprised patients who remained uninfected with omicron during their hospitalization&#xD;
        period. Hospital-acquired omicron infection was defined as having a positive reverse&#xD;
        transcription polymerase chain reaction (RT-PCR) test for omicron from a nasopharyngeal or&#xD;
        throat swab. Before admission, all the patients tested negative for omicron within 24 hours.&#xD;
        In cases where patients presented with symptoms such as fever, daily RT-PCR testing was&#xD;
        performed. A single positive result was considered sufficient evidence of infection.&#xD;
  &#xD;
        According to the Clavien-Dindo classification, surgical complications are categorized as&#xD;
        follows: Grade I encompasses medical interventions that deviate from the normal postoperative&#xD;
        course but do not require drugs, surgery, endoscopy, or radiological intervention. Acceptable&#xD;
        medical interventions may include the administration of antiemetics, antipyretics,&#xD;
        analgesics, diuretics, electrolyte management, and physical therapy. This grade also includes&#xD;
        superficial surgical site infections. Grade II involves complications that necessitate&#xD;
        pharmacological treatment in addition to Grade I interventions, such as blood transfusions or&#xD;
        total parenteral nutrition. Grade III involves complications that require surgical,&#xD;
        endoscopic, or radiological interventions. Grade IV consists of life-threatening&#xD;
        complications that require intermediate care or treatment in the intensive care unit. This&#xD;
        grade includes central nervous system complications, such as cerebral hemorrhage, ischemic&#xD;
        stroke, and subarachnoid hemorrhage, but excludes transient ischemic attacks. Finally, Grade&#xD;
        V represents patient death.&#xD;
  &#xD;
        The thoracic surgeries are classified as follows. Pulmonary surgery refers to the removal of&#xD;
        lung tissue, irrespective of the extent of resection. Digestive system surgery encompasses&#xD;
        procedures targeting diseases of the esophagus or gastroesophageal junction. The other&#xD;
        surgery includes surgeries that do not involve the removal of lung tissue, addressing&#xD;
        conditions affecting the chest wall, mediastinum, and other related areas.&#xD;
  &#xD;
        Propensity score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27&#xD;
        to assess the incidence of perioperative complications and mortality rates between both&#xD;
        groups. Considering these factors (age, sex, medical history, smoking history, disease&#xD;
        classification, the extent of surgical resection), propensity matching was performed using a&#xD;
        one-to-one nearest-neighbor matching algorithm with a match caliper standard deviation of&#xD;
        0.02. Each G1 patient was then paired with one G2 patient. Standardized mean differences were&#xD;
        calculated to evaluate the balance between the matched groups, with differences exceeding 0.1&#xD;
        indicating potential imbalance. Categorical variables were described as frequencies and&#xD;
        proportions and analyzed using the chi-square test to determine any statistical significance&#xD;
        (P &lt; 0.05). To confirm the factors contributing to the occurrence of complications, a&#xD;
        logistic regression model was constructed, which incorporated confounding variables and&#xD;
        examined their association with the occurrence of complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Actual">March 31, 2023</completion_date>
    <primary_completion_date type="Actual">March 31, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>3 Months</target_duration>
    <primary_outcome>
      <measure>Postoperative Complications</measure>
      <time_frame>up to 1 months</time_frame>
      <description>Postoperative Complications</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative Mortality</measure>
      <time_frame>up to 1 months</time_frame>
      <description>Postoperative Mortality</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">119</enrollment>
    <condition>Postoperative Complications</condition>
    <condition>Morality</condition>
    <arm_group>
      <arm_group_label>Group 1 (G1)</arm_group_label>
      <description>patients who acquired nosocomial omicron infection after surgery</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2 (G2)</arm_group_label>
      <description>patients who remained uninfected with omicron during their hospitalization period</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>In-Hospital COVID-19 Omicron Infection after surgery</intervention_name>
      <description>Thoracic Surgery Patients with In-Hospital COVID-19 Omicron Infection after surgery</description>
      <arm_group_label>Group 1 (G1)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical&#xD;
          University and the Second Affiliated Hospital of Lanzhou University between December 1,&#xD;
          2022, and January 15, 2023, were collected.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force&#xD;
               Medical University and the Second Affiliated Hospital of Lanzhou University between&#xD;
               December 1, 2022, and January 15, 2023, were collected.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Non-surgery patients.&#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>
    <overall_official>
      <last_name>Linna Liu</last_name>
      <role>Study Director</role>
      <affiliation>Tang-Du Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Air Force Medical University University of PLA</name>
        <address>
          <city>Xi'an</city>
          <state>Shannxi</state>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tang-Du Hospital</investigator_affiliation>
      <investigator_full_name>Xiaolong Yan, Dr.</investigator_full_name>
      <investigator_title>Deputy director</investigator_title>
    </responsible_party>
    <keyword>Thoracic surgery; Postoperative complications; Mortality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Postoperative Complications</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/NCT06040606
  org study id: 2023A-176
  nct id: NCT06040606
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Postoperative complications and mortality in patients with COVID-19 Omicron infection who
        have undergone specialized thoracic surgery are scarce. Subsequently, the patient cohort was
        divided into two groups for comparative analysis: Group 1 (G1), which comprised patients who
        acquired nosocomial omicron infection after surgery, and Group 2 (G2), which comprised
        patients who remained uninfected with omicron during their hospitalization period. Propensity
        score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27 to assess
        the incidence of perioperative complications and mortality rates between both groups.
  Data of patients who underwent thoracic surgery at the Tangdu Hospital of Air Force Medical
        University and the Second Affiliated Hospital of Lanzhou University between December 1, 2022,
        and January 15, 2023, were collected. The data encompassed various clinical parameters,
        including age, sex, medical history, smoking history, disease classification, the extent of
        surgical resection, time of postoperative omicron diagnosis, duration of symptoms, COVID-19
        classification (The symptoms of novel COVID-19 infection were classified as mild, medium,
        severe and critical according to the diagnosis and treatment of novel COVID-19 infection
        version 10), postoperative complications, and 30-day postoperative outcomes. Subsequently,
        the patient cohort was divided into two groups for comparative analysis: Group 1 (G1), which
        comprised patients who acquired nosocomial omicron infection after surgery, and Group 2 (G2),
        which comprised patients who remained uninfected with omicron during their hospitalization
        period. Hospital-acquired omicron infection was defined as having a positive reverse
        transcription polymerase chain reaction (RT-PCR) test for omicron from a nasopharyngeal or
        throat swab. Before admission, all the patients tested negative for omicron within 24 hours.
        In cases where patients presented with symptoms such as fever, daily RT-PCR testing was
        performed. A single positive result was considered sufficient evidence of infection.
  
        According to the Clavien-Dindo classification, surgical complications are categorized as
        follows: Grade I encompasses medical interventions that deviate from the normal postoperative
        course but do not require drugs, surgery, endoscopy, or radiological intervention. Acceptable
        medical interventions may include the administration of antiemetics, antipyretics,
        analgesics, diuretics, electrolyte management, and physical therapy. This grade also includes
        superficial surgical site infections. Grade II involves complications that necessitate
        pharmacological treatment in addition to Grade I interventions, such as blood transfusions or
        total parenteral nutrition. Grade III involves complications that require surgical,
        endoscopic, or radiological interventions. Grade IV consists of life-threatening
        complications that require intermediate care or treatment in the intensive care unit. This
        grade includes central nervous system complications, such as cerebral hemorrhage, ischemic
        stroke, and subarachnoid hemorrhage, but excludes transient ischemic attacks. Finally, Grade
        V represents patient death.
  
        The thoracic surgeries are classified as follows. Pulmonary surgery refers to the removal of
        lung tissue, irrespective of the extent of resection. Digestive system surgery encompasses
        procedures targeting diseases of the esophagus or gastroesophageal junction. The other
        surgery includes surgeries that do not involve the removal of lung tissue, addressing
        conditions affecting the chest wall, mediastinum, and other related areas.
  
        Propensity score matching (PSM) analysis was conducted using the PSMATCH function in SPSS 27
        to assess the incidence of perioperative complications and mortality rates between both
        groups. Considering these factors (age, sex, medical history, smoking history, disease
        classification, the extent of surgical resection), propensity matching was performed using a
        one-to-one nearest-neighbor matching algorithm with a match caliper standard deviation of
        0.02. Each G1 patient was then paired with one G2 patient. Standardized mean differences were
        calculated to evaluate the balance between the matched groups, with differences exceeding 0.1
        indicating potential imbalance. Categorical variables were described as frequencies and
        proportions and analyzed using the chi-square test to determine any statistical significance
        (P < 0.05). To confirm the factors contributing to the occurrence of complications, a
        logistic regression model was constructed, which incorporated confounding variables and
        examined their association with the occurrence of complications.
  observational model: Cohort
  time perspective: Prospective
  measure: Postoperative Complications
  time frame: up to 1 months
  description: Postoperative Complications
  measure: Postoperative Mortality
  time frame: up to 1 months
  description: Postoperative Mortality
  arm group label: Group 1 (G1)
  description: patients who acquired nosocomial omicron infection after surgery
  arm group label: Group 2 (G2)
  description: patients who remained uninfected with omicron during their hospitalization period
  intervention type: Procedure
  intervention name: In-Hospital COVID-19 Omicron Infection after surgery
  description: Thoracic Surgery Patients with In-Hospital COVID-19 Omicron Infection after surgery
  arm group label: Group 1 (G1)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Linna Liu
  role: Study Director
  affiliation: Tang-Du Hospital
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tang-Du Hospital
  investigator full name: Xiaolong Yan, Dr.
  investigator title: Deputy director
  mesh term: Postoperative Complications
  sharing ipd: Undecided