Reasons and Risk Factors for Unplanned Spinal Re-operation

Recruiting

• Conditions: Spine Tumor; Degeneration Spine; Spine Fracture; Spine Deformity

• Registration Number: NCT05995327
• Lead Sponsor: Peking University Third Hospital

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 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.

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. 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.

Study Timeline

• Study Start: 2012-01-01
• Status Verified: 2023-08
• Study First Submitted: 2023-08-09
• Study First Submitted QC: 2023-08-09
• Study First Posted: 2023-08-16
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70000

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
reasons of spine unplanned re-operation	30 days	We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.
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.

Trial Locations

Locations (5)

PUTH Qinhuangdao Hospital; 🇨🇳 Beijing, China

PUTH Yanqing Hospital; 🇨🇳 Beijing, China

PUTH Beifang Hospital; 🇨🇳 Beijing, China

PUTH Chongli Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China