[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650141":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":19,"responsibleParty":26,"collaborators":19,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":33,"acronym":34,"eligibilityCriteria":35,"healthyVolunteers":30,"sex":36,"minAge":19,"maxAge":19,"enrollmentInfo":37,"targetDuration":19,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":19,"overallStatus":47,"whyStopped":19,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":19},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Closed-Loop Management Programme for UROR in Orthopaedics","EXPERIMENTAL","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.",[13],"Other: Closed-Loop Quality Improvement Programme for Unplanned Return to the Operating Room in Orthopaedics",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"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.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Haixue Wang","CONTACT","+8613041196856","gwwanghaixue@126.com",{"type":27,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100650141","unplanned-return-to-the-operating-room-in-orthopaedics-closed-loop-quality-improvement-programme-100650141",false,"NCT07744633","Unplanned Return to the Operating Room in Orthopaedics: Closed-Loop Quality Improvement Programme","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","UROR-LOOP","Inclusion Criteria:\n\n* A public secondary or tertiary general hospital or specialty hospital in China.\n* Has an independent orthopaedic ward and an established orthopaedic surgical team.\n* Has performed at least 2,000 orthopaedic surgical procedures per year during each of the previous three years.\n* Is willing to participate in the study and sign the study cooperation agreement.\n* The head of the orthopaedic department, or an authorized departmental representative, is willing to provide written informed consent on behalf of the participating department.\n* Has accessible hospital discharge records, surgical and anaesthesia information systems, and the information infrastructure required for data verification.\n* Is able to provide the required aggregated and de-identified study data and complete the scheduled follow-up assessments.\n\nExclusion Criteria:\n\n* Is currently conducting a similar quality improvement programme that may affect the evaluation of the study intervention.\n* Is unable to complete the required follow-up assessments or data reporting.\n* Experiences or is expected to experience major institutional restructuring during the study period that may substantially affect implementation of the intervention.\n\nThe 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.","ALL",{"count":38,"type":39},25,"ESTIMATED","INTERVENTIONAL",[42],"NA","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.",[45,46],"Unplanned Return to the Operating Room in Orthopaedics","Closed-Loop Quality Improvement Programme","NOT_YET_RECRUITING","2026-08-04",{"date":50,"type":51},"2026-08-06","ACTUAL",{"date":53,"type":39},"2026-09",{"date":55,"type":39},"2029-12",{"name":5,"class":6}]