Intraoperative Complications, Patient Safety, Postoperative Complications, Risk Management
Conditions
Brief summary
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.
Interventions
OTHERObservational study
No intervention, observational only
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 110 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| intraoperative complications according to ClassIntra® | during surgery (intraoperatively) | All intraoperative complications are recorded and classified according to their severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of surgery | From start to the end of the surgical procedure | Time from start to end of the surgical procedure |
| Complexity of main surgical procedure | Baseline | Complexity according to British United Provident Association (BUPA) classification |
| in-hospital postoperative complications | From after surgery up to hospital discharge, timeframe up to 30 days | All postoperative complications observed during the hospital stay are recorded and classified according to their severity |
| 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 | — |
| in-hospital mortality | From after surgery up to hospital discharge, timeframe up to 30 days | — |
Countries
Australia, Austria, Greece, Ireland, Italy, Netherlands, New Zealand, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed