Reasons and Risk Factors for Unplanned Spinal Re-operation

Spine Deformity Clinical Trial

Official title:

Construction of an Ambispective Cohort for Unplanned Spinal Re-operation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995327
• Other study ID #: M2022045
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Peking University Third Hospital
• Contact: Hanqiang Ouyang
• Phone: 13810267205
• Email: ouyanghanqiang[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degeneration Spine
• Spinal Fractures
• Spine Deformity
• Spine Fracture
• Spine Tumor

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing
China	PUTH Beifang Hospital	Beijing
China	PUTH Chongli Hospital	Beijing
China	PUTH Qinhuangdao Hospital	Beijing
China	PUTH Yanqing Hospital	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking University Third Hospital	PUTH Beifang Hospital, PUTH Chongli Hospital, PUTH Qinhuangdao Hospital, PUTH Yanqing Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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 — View 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 1 — View 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):18 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of spine unplanned re-operation	We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.	30 days
Secondary	reasons of spine unplanned re-operation	We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.	30 days
Secondary	risk factors of spine unplanned re-operation	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.	30 days