Reasons and Risk Factors for Unplanned Spinal Re-operation

Sponsor
Peking University Third Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05995327
Collaborator
PUTH Beifang Hospital (Other), PUTH Chongli Hospital (Other), PUTH Qinhuangdao Hospital (Other), PUTH Yanqing Hospital (Other)
70,000
5
168
14000
83.3

Study Details

Study Description

Brief Summary

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 the 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. On ground of our database, we further summarize and analyze the clinical causes and risk factors of re-operations, aiming to explore scientific coping strategies and provide reference for continuous improvement of medical service quality.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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 of Peking University Third Hospital. 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 the unplanned re-operations that occurred in the Orthopedics Department of Peking University Third Hospital from January 2012 to December 2025. On ground of our database, we further summarize and analyze the 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, we 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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    70000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Construction of an Ambispective Cohort for Unplanned Spinal Re-operation
    Actual Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Dec 31, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    spine degenerative disease

    patients with spine degenerative disease

    spine tumor

    patients with spinal tumors

    spine deformity

    patients with spinal deformity

    spine fracture

    patients with spine fracture

    Outcome Measures

    Primary Outcome Measures

    1. incidence of spine unplanned re-operation [30 days]

      We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.

    Secondary Outcome Measures

    1. reasons of spine unplanned re-operation [30 days]

      We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.

    2. risk factors of spine unplanned re-operation [30 days]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Patients who received orthopedic surgery in Peking University Third Hospital, including spinal degeneration, spinal deformity, spinal tumor, spine fracture reduction and internal fixation

    2. Both the initial surgery and unplanned re-operation were completed in the orthopedic department of Peking University Third Hospital

    3. The interval between two surgeries is within 30 days

    4. Discharged from the orthopedics department of Peking University Third Hospital

    Exclusion Criteria:
    1. Re-operation for other systemic diseases unrelated to the initial surgery

    2. Re-operation is a clinical procedure that is not a return to the operating room, such as wound debridement and suturing, skull traction, etc. performed in the ward

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 PUTH Beifang Hospital Beijing China 100000
    2 PUTH Chongli Hospital Beijing China 100000
    3 PUTH Qinhuangdao Hospital Beijing China 100000
    4 PUTH Yanqing Hospital Beijing China 100000
    5 Peking University Third Hospital Beijing China

    Sponsors and Collaborators

    • Peking University Third Hospital
    • PUTH Beifang Hospital
    • PUTH Chongli Hospital
    • PUTH Qinhuangdao Hospital
    • PUTH Yanqing Hospital

    Investigators

    • Study Chair: Weishi Li, Peking University Third Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking University Third Hospital
    ClinicalTrials.gov Identifier:
    NCT05995327
    Other Study ID Numbers:
    • M2022045
    First Posted:
    Aug 16, 2023
    Last Update Posted:
    Aug 16, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 16, 2023