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Trial Title:
Reasons and Risk Factors for Unplanned Spinal Re-operation
NCT ID:
NCT05995327
Condition:
Degeneration Spine
Spine Deformity
Spine Tumor
Spine Fracture
Conditions: Official terms:
Spinal Fractures
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
In the retrospective cohort, patients were enrolled from January 2012 to December 2021.
They aged from 18 to 80 years with spinal disease who were hospitalized for surgery in
the orthopedics department of Peking University Third Hospital and had complete medical
records, while diagnosing of fracture, limb arthritis, limb tumor and other non-spinal
diseases were excluded.
In the prospective cohort, patients were enrolled from January 2023 to December 2025;
They aged from 18 to 80 years with spinal disease who were hospitalized for surgery in
the orthopedics department of Peking University Third Hospital, while diagnosing of
fracture, limb arthritis, limb tumor and other non-spinal diseases were excluded.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
PUTH Beifang Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanqiang Ouyang
Phone:
13810267205
Email:
ouyanghanqiang@bjmu.edu.cn
Facility:
Name:
PUTH Chongli Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanyu Hu
Email:
huyuanyu@bjmu.edu.cn
Facility:
Name:
PUTH Qinhuangdao Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanqiang Ouyang
Phone:
13810267205
Email:
ouyanghanqiang@bjmu.edu.cn
Facility:
Name:
PUTH Yanqing Hospital
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanyu Hu
Email:
huyuanyu@bjmu.edu.cn
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Hanqiang Ouyang
Phone:
13810267205
Email:
ouyanghanqiang@bjmu.edu.cn
Start date:
January 1, 2012
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Peking University Third Hospital
Agency class:
Other
Collaborator:
Agency:
PUTH Beifang Hospital
Agency class:
Other
Collaborator:
Agency:
PUTH Chongli Hospital
Agency class:
Other
Collaborator:
Agency:
PUTH Qinhuangdao Hospital
Agency class:
Other
Collaborator:
Agency:
PUTH Yanqing Hospital
Agency class:
Other
Source:
Peking University Third Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05995327
