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CLASSIC Outline

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.

Outcome Measures

Primary Outcome Measures

  1. Intraoperative complications according to CLASSIC [ Time Frame: during surgery (intraoperatively) ]. All intraoperative complications are recorded and classified according to their severity.

Secondary Outcome Measures

  1. In-hospital postoperative complications [ Time Frame: 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
  2. Duration of surgery [ Time Frame: From start to the end of the surgical procedure ]. Time from start to end of the surgical procedure.
  3. Complexity of main surgical procedure [ Time Frame: Baseline ]. Complexity according to British United Provident Association (BUPA) classification.
  4. In-hospital mortality [ Time Frame: From after surgery up to hospital discharge, timeframe up to 30 days ]
  5. 30-day mortality [ Time Frame: 30 days postoperatively ]
  6. Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians [ Time Frame: Baseline ]

Eligibility Criteria

Ages Eligible for Study: up to 110 Years (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Sampling Method: Probability Sample

Study Population

All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement

Criteria

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)