Validation Study of ClassIntra®

Study Overview
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Brief Summary
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Whereas there are several validated systems for reporting postoperative complications, there are only a few and not prospectively validated systems for reporting intraoperative complications. The investigators developed a definition and CLASSification for Intraoperative Complications CLASSIC within a Delphi study involving international interdisciplinary experts. As both surgery and anaesthesia may be involved in complications in the perioperative period, all patient-related intraoperative complications occurring between skin incision and closure are considered in this reporting system. CLASSIC was updated to ClassIntra® v1·0, by encompassing five severity grades to align with the validated Clavien-Dindo Classification for grading postoperative complications. The aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived and updated classification system ClassIntra® in patient undergoing an in-hospital surgical procedure. Providing an easy applicable and internationally validated classification system is a contribution to improve quality of health care and patient safety.

Official Title
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International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events

Conditions
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Patient Safety, Intraoperative Complications, Postoperative Complications, Risk Management

Intervention / Treatment
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* Other: Observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement Exclusion Criteria: Outpatients (patients undergoing one-day-surgery) (with and without anaesthesia-involvement) Procedures without anaesthesia-involvement (in- or out-patient) ASA risk classification (ASA) VI patients (brain-death organ-donor)

Ages Eligible for Study
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Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational study|No intervention, observational only|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative complications according to ClassIntra® | All intraoperative complications are recorded and classified according to their severity | during surgery (intraoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital postoperative complications | All postoperative complications observed during the hospital stay are recorded and classified according to their severity | From after surgery up to hospital discharge, timeframe up to 30 days | 
| Duration of surgery | Time from start to end of the surgical procedure | From start to the end of the surgical procedure | 
| Complexity of main surgical procedure | Complexity according to British United Provident Association (BUPA) classification | Baseline | 
| in-hospital mortality |  | From after surgery up to hospital discharge, timeframe up to 30 days | 
| 30-day mortality |  | 30 days postoperatively | 
| Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians |  | Baseline |