Validation Study of CLASSIC

Background

Quantifiable evidence-based methods of defining and reporting complications are needed to
improve patient safety in surgery. 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 and published a
definition and classification for intraoperative complications within a Delphi study
involving international interdisciplinary experts.

The aim of this research project is to assess the validity and practicability of this newly
derived classification system.

Methods

In 6 centres in Switzerland and 13 centres abroad, 2500 consecutive patients undergoing any
type of inpatient surgery will be included in this prospective international multicentre
cohort study. The primary endpoint corresponds to the risk-adjusted association between the
most severe intraoperative complication classified according to CLASSIC and the most severe
postoperative complication classified according to the most commonly used classification of
postoperative complications developed by Clavien and Dindo. All observed patient-related
intraoperative complications between skin incision and closure are considered as
intraoperative complications.

Expected results

The investigators expect a high correlation between the most severe intra- and postoperative
complications, even after adjustment for relevant confounders such as duration and complexity
of the surgical procedure.

Relevance

Confirming a high correlation between intra- and postoperative complications, more attentive
care could be provided to patients who suffered from a severe intraoperative complication.
Additionally, providing an easy applicable and internationally validated classification
system is a contribution to improve quality of perioperative health care and patient safety.

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)