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/NCT05995327</url>
    </required_header>
    <id_info>
      <org_study_id>M2022045</org_study_id>
      <nct_id>NCT05995327</nct_id>
    </id_info>
    <brief_title>Reasons and Risk Factors for Unplanned Spinal Re-operation</brief_title>
    <official_title>Construction of an Ambispective Cohort for Unplanned Spinal Re-operation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>PUTH Beifang Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PUTH Chongli Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PUTH Qinhuangdao Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>PUTH Yanqing Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University Third Hospital</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>
        Unplanned re-operation is one of the common negative indicators reflecting the quality and&#xD;
        safety of surgery in the medical industry and has become one of the ten goals for the&#xD;
        improvement of national medical quality and safety in China since 2022, while about 40% of&#xD;
        unplanned re-operations in Peking University Third Hospital in recent years occur in spine&#xD;
        patients of the orthopedics department. This project intends to establish a high-quality and&#xD;
        sustainable ambispective disease cohort for spine surgery in Peking University Third Hospital&#xD;
        based on the unplanned re-operations that occurred in the Orthopedics Department of Peking&#xD;
        University Third Hospital from January 2012 to December 2025. The investigators further&#xD;
        summarize and analyze clinical causes and risk factors of re-operations, aiming to explore&#xD;
        scientific coping strategies and provide reference for continuous improvement of medical&#xD;
        service quality.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Unplanned re-operation is one of the common negative indicators reflecting the quality and&#xD;
        safety of surgery in the medical industry. Possible reasons for a patient's return to the&#xD;
        operating room include problems with surgical technique, anesthesia procedures, or infection&#xD;
        control. Reducing the rate of unplanned re-operation has become one of the ten goals for the&#xD;
        improvement of national medical quality and safety in China since 2022, and has been paid&#xD;
        more and more attention by the National Health Commission and hospital managers.&#xD;
  &#xD;
        About 40% of the unplanned re-operations in Peking University Third Hospital in recent years&#xD;
        occur in spine patients of the orthopedics department, thus lowering the rate of spine&#xD;
        unplanned re-operations is of great significance to improve the overall medical quality and&#xD;
        safety. Driven by the common needs and joint force of &quot;nation-hospital-department&quot;, this&#xD;
        project intends to establish a high-quality and sustainable ambispective disease cohort for&#xD;
        spine surgery in Peking University Third Hospital based on unplanned re-operations that&#xD;
        occurred in the Orthopedics Department of Peking University Third Hospital from January 2012&#xD;
        to December 2025. The investigators further summarize and analyze clinical causes and risk&#xD;
        factors of re-operations, aiming to explore scientific coping strategies and provide&#xD;
        reference for continuous improvement of medical service quality. Furthermore, the&#xD;
        investigators intend to construct multiple risk prediction models for spine unplanned&#xD;
        re-operation and special disease cohorts. This project will form a synergy in the three&#xD;
        aspects of &quot;clinical, scientific research, and management&quot;, lower the unplanned re-operation&#xD;
        rate of orthopedic spinal surgery, improve medical quality and safety management in Peking&#xD;
        University Third Hospital, and promote the in-depth exploration and vigorous development of&#xD;
        spine discipline in the scientific fields of perioperative safety and risk assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2012</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>incidence of spine unplanned re-operation</measure>
      <time_frame>30 days</time_frame>
      <description>We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>reasons of spine unplanned re-operation</measure>
      <time_frame>30 days</time_frame>
      <description>We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>risk factors of spine unplanned re-operation</measure>
      <time_frame>30 days</time_frame>
      <description>We figure out risk factors of spine unplanned re-operation and that of specialized spinal diseases by comparing conditions between patients underwent unplanned re-operation or not.</description>
    </secondary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">70000</enrollment>
    <condition>Degeneration Spine</condition>
    <condition>Spine Deformity</condition>
    <condition>Spine Tumor</condition>
    <condition>Spine Fracture</condition>
    <arm_group>
      <arm_group_label>spine degenerative disease</arm_group_label>
      <description>patients with spine degenerative disease</description>
    </arm_group>
    <arm_group>
      <arm_group_label>spine tumor</arm_group_label>
      <description>patients with spinal tumors</description>
    </arm_group>
    <arm_group>
      <arm_group_label>spine deformity</arm_group_label>
      <description>patients with spinal deformity</description>
    </arm_group>
    <arm_group>
      <arm_group_label>spine fracture</arm_group_label>
      <description>patients with spine fracture</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          In the retrospective cohort, patients were enrolled from January 2012 to December 2021.&#xD;
          They aged from 18 to 80 years with spinal disease who were hospitalized for surgery in the&#xD;
          orthopedics department of Peking University Third Hospital and had complete medical&#xD;
          records, while diagnosing of fracture, limb arthritis, limb tumor and other non-spinal&#xD;
          diseases were excluded.&#xD;
  &#xD;
          In the prospective cohort, patients were enrolled from January 2023 to December 2025; They&#xD;
          aged from 18 to 80 years with spinal disease who were hospitalized for surgery in the&#xD;
          orthopedics department of Peking University Third Hospital, while diagnosing of fracture,&#xD;
          limb arthritis, limb tumor and other non-spinal diseases were excluded.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients who received orthopedic surgery in Peking University Third Hospital,&#xD;
               including spinal degeneration, spinal deformity, spinal tumor, spine fracture&#xD;
               reduction and internal fixation&#xD;
  &#xD;
            2. Both the initial surgery and unplanned re-operation were completed in the orthopedic&#xD;
               department of Peking University Third Hospital&#xD;
  &#xD;
            3. The interval between two surgeries is within 30 days&#xD;
  &#xD;
            4. Discharged from the orthopedics department of Peking University Third Hospital&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Re-operation for other systemic diseases unrelated to the initial surgery&#xD;
  &#xD;
            2. Re-operation is a clinical procedure that is not a return to the operating room, such&#xD;
               as wound debridement and suturing, skull traction, etc. performed in the ward&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Weishi Li</last_name>
      <role>Study Chair</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hanqiang Ouyang</last_name>
      <phone>13810267205</phone>
      <email>ouyanghanqiang@bjmu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>PUTH Beifang Hospital</name>
        <address>
          <city>Beijing</city>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hanqiang Ouyang</last_name>
        <phone>13810267205</phone>
        <email>ouyanghanqiang@bjmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>PUTH Chongli Hospital</name>
        <address>
          <city>Beijing</city>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuanyu Hu</last_name>
        <email>huyuanyu@bjmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>PUTH Qinhuangdao Hospital</name>
        <address>
          <city>Beijing</city>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hanqiang Ouyang</last_name>
        <phone>13810267205</phone>
        <email>ouyanghanqiang@bjmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>PUTH Yanqing Hospital</name>
        <address>
          <city>Beijing</city>
          <zip>100000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuanyu Hu</last_name>
        <email>huyuanyu@bjmu.edu.cn</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hanqiang Ouyang</last_name>
        <phone>13810267205</phone>
        <email>ouyanghanqiang@bjmu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <results_reference>
      <citation>Ouyang H, Hu Y, Hu W, Zhang H, Sun Z, Tang Y, Jiang Y, Chen J, Dong S, Li W, Tian Y. Incidences, causes and risk factors of unplanned reoperations within 30 days of spine surgery: a single-center study based on 35,246 patients. Spine J. 2022 Nov;22(11):1811-1819. doi: 10.1016/j.spinee.2022.07.098. Epub 2022 Jul 22.</citation>
      <PMID>35878756</PMID>
    </results_reference>
    <results_reference>
      <citation>Hu Y, Ouyang H, Ye K, Qi J, Dong Y, Peng X, Zhang X, Dong S, Chen Z, Liu Z, Liu X, Sun C, Li W, Tian Y. Thirty-day Unplanned Reoperations After Posterior Surgery for Thoracic Spinal Stenosis: A Single-center Study Based on 1948 Patients. Spine (Phila Pa 1976). 2023 Apr 1;48(7):507-513. doi: 10.1097/BRS.0000000000004499. Epub 2022 Oct 3.</citation>
      <PMID>36191058</PMID>
    </results_reference>
    <results_reference>
      <citation>Hu Y, Ouyang H, Ye K, Dong Y, Zhang X, Dong S, Chen Z, Liu Z, Liu X, Zeng Y, Wei F, Sun C, Tian Y, Li W. Thirty-day unplanned reoperations of thoracic spine surgery: 10 years of data from a single center with 3242 patients. Spine J. 2023 May;23(5):703-714. doi: 10.1016/j.spinee.2023.01.005. Epub 2023 Jan 11.</citation>
      <PMID>36641036</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 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>Spinal Fractures</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/NCT05995327
  org study id: M2022045
  nct id: NCT05995327
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Unplanned re-operation is one of the common negative indicators reflecting the quality and
        safety of surgery in the medical industry and has become one of the ten goals for the
        improvement of national medical quality and safety in China since 2022, while about 40% of
        unplanned re-operations in Peking University Third Hospital in recent years occur in spine
        patients of the orthopedics department. This project intends to establish a high-quality and
        sustainable ambispective disease cohort for spine surgery in Peking University Third Hospital
        based on the unplanned re-operations that occurred in the Orthopedics Department of Peking
        University Third Hospital from January 2012 to December 2025. The investigators further
        summarize and analyze clinical causes and risk factors of re-operations, aiming to explore
        scientific coping strategies and provide reference for continuous improvement of medical
        service quality.
  Unplanned re-operation is one of the common negative indicators reflecting the quality and
        safety of surgery in the medical industry. Possible reasons for a patient's return to the
        operating room include problems with surgical technique, anesthesia procedures, or infection
        control. Reducing the rate of unplanned re-operation has become one of the ten goals for the
        improvement of national medical quality and safety in China since 2022, and has been paid
        more and more attention by the National Health Commission and hospital managers.
  
        About 40% of the unplanned re-operations in Peking University Third Hospital in recent years
        occur in spine patients of the orthopedics department, thus lowering the rate of spine
        unplanned re-operations is of great significance to improve the overall medical quality and
        safety. Driven by the common needs and joint force of "nation-hospital-department", this
        project intends to establish a high-quality and sustainable ambispective disease cohort for
        spine surgery in Peking University Third Hospital based on unplanned re-operations that
        occurred in the Orthopedics Department of Peking University Third Hospital from January 2012
        to December 2025. The investigators further summarize and analyze clinical causes and risk
        factors of re-operations, aiming to explore scientific coping strategies and provide
        reference for continuous improvement of medical service quality. Furthermore, the
        investigators intend to construct multiple risk prediction models for spine unplanned
        re-operation and special disease cohorts. This project will form a synergy in the three
        aspects of "clinical, scientific research, and management", lower the unplanned re-operation
        rate of orthopedic spinal surgery, improve medical quality and safety management in Peking
        University Third Hospital, and promote the in-depth exploration and vigorous development of
        spine discipline in the scientific fields of perioperative safety and risk assessment.
  observational model: Cohort
  time perspective: Other
  measure: incidence of spine unplanned re-operation
  time frame: 30 days
  description: We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.
  measure: reasons of spine unplanned re-operation
  time frame: 30 days
  description: We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.
  measure: risk factors of spine unplanned re-operation
  time frame: 30 days
  description: We figure out risk factors of spine unplanned re-operation and that of specialized spinal diseases by comparing conditions between patients underwent unplanned re-operation or not.
  arm group label: spine degenerative disease
  description: patients with spine degenerative disease
  arm group label: spine tumor
  description: patients with spinal tumors
  arm group label: spine deformity
  description: patients with spinal deformity
  arm group label: spine fracture
  description: patients with spine fracture
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Weishi Li
  role: Study Chair
  affiliation: Peking University Third Hospital
  last name: Hanqiang Ouyang
  phone: 13810267205
  email: ouyanghanqiang@bjmu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: Ouyang H, Hu Y, Hu W, Zhang H, Sun Z, Tang Y, Jiang Y, Chen J, Dong S, Li W, Tian Y. Incidences, causes and risk factors of unplanned reoperations within 30 days of spine surgery: a single-center study based on 35,246 patients. Spine J. 2022 Nov;22(11):1811-1819. doi: 10.1016/j.spinee.2022.07.098. Epub 2022 Jul 22.
  PMID: 35878756
  citation: Hu Y, Ouyang H, Ye K, Qi J, Dong Y, Peng X, Zhang X, Dong S, Chen Z, Liu Z, Liu X, Sun C, Li W, Tian Y. Thirty-day Unplanned Reoperations After Posterior Surgery for Thoracic Spinal Stenosis: A Single-center Study Based on 1948 Patients. Spine (Phila Pa 1976). 2023 Apr 1;48(7):507-513. doi: 10.1097/BRS.0000000000004499. Epub 2022 Oct 3.
  PMID: 36191058
  citation: Hu Y, Ouyang H, Ye K, Dong Y, Zhang X, Dong S, Chen Z, Liu Z, Liu X, Zeng Y, Wei F, Sun C, Tian Y, Li W. Thirty-day unplanned reoperations of thoracic spine surgery: 10 years of data from a single center with 3242 patients. Spine J. 2023 May;23(5):703-714. doi: 10.1016/j.spinee.2023.01.005. Epub 2023 Jan 11.
  PMID: 36641036
  responsible party type: Sponsor
  mesh term: Spinal Fractures
  sharing ipd: No