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Unplanned Return to the Operating Room in Orthopaedics: Closed-Loop Quality Improvement Programme

NCT07744633 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-08-06

No results posted yet for this study

Summary

This multicentre, prospective, before-and-after quality improvement study will evaluate a hospital-level closed-loop management programme for unplanned return to the operating room in orthopaedics. The unit of enrollment, intervention, and analysis is the participating hospital and its orthopaedic department. Approximately 20-30 secondary or tertiary public hospitals in China will be included. Individual patients will not be recruited as research participants, and only aggregated and de-identified hospital-level data will be collected.After baseline assessment and standardized training, participating orthopaedic departments will implement a closed-loop management programme comprising six core components: standardization of the definition of unplanned return to the operating room; establishment of a non-punitive reporting mechanism; appointment of a departmental coordinator; monthly case registration and multi-source data verification; regular department-wide case review and root-cause analysis; and development, implementation, and follow-up of continuous quality improvement actions.The primary outcomes include the underreporting rate or reporting accuracy and indicators of management quality, such as coordinator appointment, active reporting, case registration, data verification, case review, and completion of the closed-loop management process. Secondary outcomes include the rate of unplanned return to the operating room, common postoperative complications, mortality, unplanned readmission, length of hospital stay, and hospitalization costs. Intervention adherence will be assessed quarterly, and study outcomes will be evaluated every six months during the 36-month study period. The intervention will not alter patients' clinical treatment or require additional diagnostic or therapeutic procedures.

Conditions

  • Unplanned Return to the Operating Room in Orthopaedics
  • Closed-Loop Quality Improvement Programme

Interventions

OTHER

Closed-Loop Quality Improvement Programme for Unplanned Return to the Operating Room in Orthopaedics

This hospital-level organizational and behavioral quality improvement intervention aims to improve the management of unplanned return to the operating room in orthopaedics. Following standardized training and system establishment, participating departments will implement a closed-loop management programme comprising six components: a standardized definition; a non-punitive reporting mechanism; appointment of a departmental coordinator; monthly case registration and multi-source verification using departmental records, adverse-event reporting systems, medical records, and surgical or anaesthesia information systems; regular department-wide case review and root-cause analysis; and development, implementation, and follow-up of continuous improvement actions. The programme will operate continuously, with monthly management activities and quarterly adherence assessments. It does not alter clinical treatment or require additional diagnostic or therapeutic procedures.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2029-12-31
Completion
2029-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07744633 on ClinicalTrials.gov