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Reasons and Risk Factors for Unplanned Spinal Re-operation

Construction of an Ambispective Cohort for Unplanned Spinal Re-operation

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05995327
Enrollment
70000
Registered
2023-08-16
Start date
2012-01-01
Completion date
2025-12-31
Last updated
2023-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degeneration Spine, Spine Deformity, Spine Fracture, Spine Tumor

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.

Interventions

None listed

Sponsors

PUTH Beifang Hospital
CollaboratorUNKNOWN
PUTH Chongli Hospital
CollaboratorUNKNOWN
PUTH Qinhuangdao Hospital
CollaboratorUNKNOWN
PUTH Yanqing Hospital
CollaboratorUNKNOWN
Peking University Third Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
incidence of spine unplanned re-operation30 daysWe calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.

Secondary

MeasureTime frameDescription
reasons of spine unplanned re-operation30 daysWe summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.
risk factors of spine unplanned re-operation30 daysWe 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.

Countries

China

Contacts

Primary ContactHanqiang Ouyang
ouyanghanqiang@bjmu.edu.cn13810267205

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026