Reasons and Risk Factors for Unplanned Spinal Re-operation

NCT05995327 | Unknown DMC

• 1 other identifier: M2022045
• Study Type: observational
• Target: 70,000
• Locations: 1 country
• Sites: 5

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.

Conditions

Degeneration Spine; Spine Deformity; Spine Tumor; Spine Fracture

Outcome Measures

Primary Outcomes (1)

• incidence of spine unplanned re-operation

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

  30 days

Secondary Outcomes (2)

• reasons of spine unplanned re-operation

  30 days

• risk factors of spine unplanned re-operation

  30 days

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients who received orthopedic surgery in Peking University Third Hospital, including spinal degeneration, spinal deformity, spinal tumor, spine fracture reduction and internal fixation
• Both the initial surgery and unplanned re-operation were completed in the orthopedic department of Peking University Third Hospital
• The interval between two surgeries is within 30 days
• Discharged from the orthopedics department of Peking University Third Hospital

You may not qualify if:

• Re-operation for other systemic diseases unrelated to the initial surgery
• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• PUTH Beifang Hospital: collaborator
• PUTH Chongli Hospital: collaborator
• PUTH Qinhuangdao Hospital: collaborator
• PUTH Yanqing Hospital: collaborator

Study Sites (5)

PUTH Beifang Hospital

Beijing, 100000, China

RECRUITING

PUTH Chongli Hospital

Beijing, 100000, China

RECRUITING

PUTH Qinhuangdao Hospital

Beijing, 100000, China

RECRUITING

PUTH Yanqing Hospital

Beijing, 100000, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

Related Publications (3)

• 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):1811-1819. doi: 10.1016/j.spinee.2022.07.098. Epub 2022 Jul 22.

  PMID: 35878756 RESULT

• 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 1976). 2023 Apr 1;48(7):507-513. doi: 10.1097/BRS.0000000000004499. Epub 2022 Oct 3.

  PMID: 36191058 RESULT

• 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. doi: 10.1016/j.spinee.2023.01.005. Epub 2023 Jan 11.

  PMID: 36641036 RESULT

MeSH Terms

Conditions

Spinal Fractures

Condition Hierarchy (Ancestors)

Spinal Injuries; Back Injuries; Wounds and Injuries; Fractures, Bone

Study Officials

• Weishi Li

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Hanqiang Ouyang

CONTACT

13810267205; ouyanghanqiang@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2023
• First Posted: August 16, 2023
• Study Start: January 1, 2012
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)