Unplanned Return to the Operating Room in Orthopaedics: Closed-Loop Quality Improvement Programme (UROR-LOOP)

Effectiveness of a Hospital-Level Closed-Loop Management System for Unplanned Return to the Operating Room in Orthopaedics: A Multicentre, Prospective, Before-and-After Quality Improvement Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Unplanned Return to the Operating Room in Orthopaedics; Closed-Loop Quality Improvement Programme
• Intervention / Treatment: Other: Closed-Loop Quality Improvement Programme for Unplanned Return to the Operating Room in Orthopaedics

Detailed Description

Unplanned return to the operating room is an important indicator of surgical quality and patient safety. It is associated with increased risks of postoperative complications, mortality, prolonged hospitalization, higher medical costs, and greater use of healthcare resources. In orthopaedic practice, patients may require unplanned repeat surgery because of postoperative infection, bleeding or haematoma, venous thromboembolism, implant-related complications, neurological deterioration, wound problems, or other adverse events. However, the reported rate of unplanned return to the operating room may be affected by incomplete case registration, underreporting, insufficient data verification, and the absence of systematic case review and continuous improvement mechanisms.This study aims to evaluate the effectiveness of a standardized closed-loop quality improvement programme for the management of unplanned return to the operating room in orthopaedics. The programme is based on a management framework of monitoring and reporting, analysis and feedback, and continuous improvement. It is intended to improve the completeness and accuracy of case reporting, strengthen hospital-level management processes, and potentially reduce adverse surgical outcomes.This is a multicentre, prospective, hospital-level cluster before-and-after quality improvement study. The unit of enrollment, intervention, and analysis is the participating hospital and its orthopaedic department. Approximately 20 to 30 secondary or tertiary public general or specialty hospitals in China will be included. Each participating hospital must have an independent orthopaedic ward and surgical team, an annual orthopaedic surgical volume of at least 2,000 procedures during each of the previous three years, and the information systems and management capacity required for case registration, data verification, and follow-up.Individual patients will not be recruited as research participants, and no patient will be assigned to a research treatment. The intervention is implemented at the hospital and orthopaedic department level. Only aggregated and de-identified hospital-level data will be collected. The head of the participating orthopaedic department, or an authorized departmental representative, will provide written informed consent for participation of the department.For this study, unplanned return to the operating room is defined as an unplanned repeat surgical procedure required after an orthopaedic operation. It includes an unplanned return to the operating room within 31 days after the original procedure, either during the same hospitalization or following readmission. It may include repeat orthopaedic surgery, surgery performed by another specialty, or an unplanned repeat operation performed at another medical institution. Procedures that were planned before the original operation as part of a staged surgical strategy are excluded.Before implementation of the intervention, participating hospitals will complete a baseline assessment of their existing management systems, reporting practices, information systems, orthopaedic surgical volume, unplanned return to the operating room, postoperative complications, mortality, length of hospital stay, and hospitalization costs. Historical data on unplanned return to the operating room and reporting practices will also be collected when available.After baseline assessment, participating orthopaedic departments will receive standardized training and establish a closed-loop management system. The intervention includes six core components.First, the definition and reporting criteria for unplanned return to the operating room will be standardized across participating hospitals.Second, each department will establish a non-punitive reporting mechanism that encourages healthcare professionals to report cases actively, accurately, and promptly, with an emphasis on learning from adverse events and improving care processes.Third, each participating orthopaedic department will appoint a designated coordinator responsible for case collection, registration, data verification, reporting, organization of case-review meetings, documentation, and follow-up of improvement actions.Fourth, cases will be registered monthly and verified using multiple data sources. These sources may include departmental case records, hospital adverse-event reporting systems, hospital discharge records, medical record databases, and surgical or anaesthesia information systems. The purpose of this verification is to identify missed cases and improve the completeness and accuracy of reporting.Fifth, participating departments will conduct regular department-wide case-review meetings. These meetings will review the causes of unplanned repeat surgery, identify weaknesses in diagnosis, treatment, perioperative management, communication, documentation, and organizational processes, and conduct root-cause analyses when appropriate.Sixth, departments will develop, implement, document, and follow up continuous quality improvement actions based on problems identified through case review and data analysis. Improvement actions may involve revision of clinical or management procedures, staff training, strengthening of perioperative assessment, improvement of case reporting, or optimization of multidisciplinary coordination.The closed-loop management programme will be implemented continuously after the initial training and system-establishment period. Monthly management activities will include case registration, data verification, reporting, case review, and follow-up of improvement actions. Adherence to the intervention will be assessed quarterly. Study outcomes will be evaluated every six months during the 36-month follow-up period.The primary outcomes include the underreporting rate or reporting accuracy of unplanned return to the operating room and hospital-level management quality indicators. Management quality indicators include the proportion of hospitals appointing a departmental coordinator, active reporting rate, completion rate of departmental case registration, data-verification rate, completion rate of case-review documentation, department-wide case-review rate, implementation rate of improvement actions, and completion rate of the overall closed-loop management process.Secondary outcomes include the overall rate of unplanned return to the operating room in orthopaedics; rates of common postoperative complications, including bleeding or haematoma, infection, venous thromboembolism, implant-related complications, drainage-related complications, and mortality; unplanned readmission; average length of hospital stay; hospitalization costs; and the causes and factors associated with unplanned return to the operating room and underreporting.The intervention does not alter patients' clinical treatment, require additional diagnostic tests, or involve additional therapeutic or invasive procedures. It is therefore considered a minimal-risk organizational and behavioral quality improvement intervention.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haixue Wang; Phone Number: +8613041196856; Email: gwwanghaixue@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A public secondary or tertiary general hospital or specialty hospital in China.
• Has an independent orthopaedic ward and an established orthopaedic surgical team.
• Has performed at least 2,000 orthopaedic surgical procedures per year during each of the previous three years.
• Is willing to participate in the study and sign the study cooperation agreement.
• The head of the orthopaedic department, or an authorized departmental representative, is willing to provide written informed consent on behalf of the participating department.
• Has accessible hospital discharge records, surgical and anaesthesia information systems, and the information infrastructure required for data verification.
• Is able to provide the required aggregated and de-identified study data and complete the scheduled follow-up assessments.

Exclusion Criteria:

• Is currently conducting a similar quality improvement programme that may affect the evaluation of the study intervention.
• Is unable to complete the required follow-up assessments or data reporting.
• Experiences or is expected to experience major institutional restructuring during the study period that may substantially affect implementation of the intervention.

The unit of enrollment, intervention, and analysis is the participating hospital and its orthopaedic department. Individual patients are not recruited as research participants. Only aggregated and de-identified hospital-level data will be collected.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Closed-Loop Management Programme for UROR in Orthopaedics; Participating orthopaedic departments will first undergo a baseline assessment of their existing management and reporting practices for unplanned return to the operating room. They will then implement a standardized hospital-level closed-loop quality improvement programme. The programme includes standardizing the definition of unplanned return to the operating room, establishing a non-punitive reporting mechanism, appointing a departmental coordinator, conducting multi-source data verification, organizing regular department-wide case reviews and root-cause analyses, and developing and implementing continuous quality improvement actions. Implementation fidelity will be assessed quarterly, and study outcomes will be evaluated every six months during the 36-month study period.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Underreporting Rate of Unplanned Return to the Operating Room in Orthopaedics	The percentage of verified cases of unplanned return to the operating room (UROR) that were not reported through the designated hospital reporting pathway during each assessment period. UROR cases will be identified and verified by cross-checking departmental case registries, hospital adverse-event reporting systems, medical records, and surgical or anaesthesia information systems. The underreporting rate will be calculated as the number of verified UROR cases not formally reported divided by the total number of verified UROR cases, multiplied by 100%.	Baseline and 12, 24, and 36 months after implementation
Implementation Rates of Predefined Closed-Loop Management Components	At each assessment, the implementation rate of each prespecified closed-loop management component will be calculated separately as the number of participating orthopaedic departments meeting the component-specific implementation criterion divided by the total number of departments assessed, multiplied by 100%. Components include: appointment of a designated departmental coordinator; completion of a standardized UROR case registry; multi-source case verification; completion of standardized case-review records; department-wide review of verified UROR cases; and documented development, implementation, and follow-up of quality improvement actions. Results will be reported separately for each component.	Baseline and 12, 24, and 36 months after implementation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Unplanned Return to the Operating Room in Orthopaedics	The percentage of orthopaedic surgical procedures followed by a verified unplanned return to the operating room during each assessment period. The rate will be calculated as the number of verified UROR cases divided by the total number of orthopaedic surgical procedures performed during the same period, multiplied by 100%. A verified UROR includes an unplanned repeat operation within 31 days of the original procedure, during the same hospitalization or following readmission, and excludes preplanned staged procedures.	Baseline and 12, 24, and 36 months after implementation
Rates of Predefined Postoperative Complications in Orthopaedics	The percentage of orthopaedic surgical patients experiencing each prespecified postoperative complication during the assessment period. Complications include bleeding or haematoma, surgical site or other postoperative infection, venous thromboembolism, implant-related complications, drainage-related complications, and other protocol-defined complications. The rate for each complication will be calculated separately as the number of patients with the complication divided by the total number of orthopaedic surgical patients, multiplied by 100%.	Baseline and 12, 24, and 36 months after implementation
Unplanned Readmission Rate After Orthopaedic Surgery	The percentage of orthopaedic surgical patients who experience an unplanned readmission after discharge during the prespecified follow-up period. The rate will be calculated as the number of patients with an unplanned readmission divided by the total number of discharged orthopaedic surgical patients eligible for assessment, multiplied by 100%.	Baseline and 12, 24, and 36 months after implementation
Mean Length of Hospital Stay Among Orthopaedic Surgical Patients	The hospital-level mean length of stay among orthopaedic surgical patients during each assessment period. Length of stay will be calculated from the date of hospital admission to the date of discharge and summarized in days using aggregated hospital-level data.	Baseline and 12, 24, and 36 months after implementation
Mean Hospitalization Cost Among Orthopaedic Surgical Patients	The hospital-level mean total hospitalization cost among orthopaedic surgical patients during each assessment period. Total hospitalization cost will be obtained from the participating hospital's standardized administrative or medical record data and reported using aggregated hospital-level data in Chinese yuan.	Baseline and 12, 24, and 36 months after implementation

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: July 29, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 6, 2026
• Last Update Submitted That Met QC Criteria: August 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Orthopedic Procedures
• Other Study ID Numbers: PKUTH-ORTHO-UROR-M20260618

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No