Degeneration SpineNCT05995327
Reasons and Risk Factors for Unplanned Spinal Re-operation
An observational study of Degeneration Spine and Spine Deformity, run by Peking University Third Hospital at 5 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Degeneration Spine, Spine Deformity, Spine Tumor
- How many people
- 70,000 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2012to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
PUTH Beifang Hospital
Beijing, 100000
Hanqiang Ouyang, 13810267205, ouyanghanqiang@bjmu.edu.cn
- Recruiting
PUTH Chongli Hospital
Beijing, 100000
Yuanyu Hu, huyuanyu@bjmu.edu.cn
- Recruiting
PUTH Qinhuangdao Hospital
Beijing, 100000
Hanqiang Ouyang, 13810267205, ouyanghanqiang@bjmu.edu.cn
- Recruiting
PUTH Yanqing Hospital
Beijing, 100000
Yuanyu Hu, huyuanyu@bjmu.edu.cn
- Recruiting
Peking University Third Hospital
Beijing
Hanqiang Ouyang, 13810267205, ouyanghanqiang@bjmu.edu.cn
About this study
Official title: Construction of an Ambispective Cohort for Unplanned Spinal Re-operation
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.
Read the 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.
- Conditions
- Degeneration Spine, Spine Deformity, Spine Tumor, Spine Fracture
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of spine unplanned re-operation
We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.
Measured: 30 days
Secondary outcomes (2)
reasons of spine unplanned re-operation
We summarize reasons of spine unplanned re-operation in total and that of specialized spinal diseases.
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Degeneration SpineStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PUTH Beifang Hospital, PUTH Chongli Hospital, PUTH Qinhuangdao Hospital, PUTH Yanqing Hospital
- Responsible party
- Sponsor
- Investigators
- Weishi Li, Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05995327
- Sponsor's protocol ID
- M2022045
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35878756Hu 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.
PubMed 36191058Hu 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.
PubMed 36641036
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction of an Ambispective Cohort for Unplanned Spinal Re-operation
- ClinicalTrials.gov ID
- NCT05995327
- Acronym / sponsor ID
- M2022045
- Conditions
- Degeneration Spine, Spine Deformity, Spine Tumor, Spine Fracture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- PUTH Beifang Hospital, PUTH Chongli Hospital, PUTH Qinhuangdao Hospital, PUTH Yanqing Hospital
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of spine unplanned re-operation
Time frame: 30 days
We calculate the unplanned re-operation incidences in total and that of specialized spinal diseases.
2 secondary outcomes
reasons of spine unplanned re-operation
Time frame: 30 days
risk factors of spine unplanned re-operation
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Results publication: PubMed 35878756Ouyang 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.
- Results publication: PubMed 36191058Hu 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.
- Results publication: PubMed 36641036Hu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weishi Li study chair
Peking University Third Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration Spine and Spine Deformity, run by Peking University Third Hospital at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hanqiang Ouyang (13810267205, ouyanghanqiang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of spine unplanned re-operation (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05995327, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.