Clinical Trial: Validation Study of CLASSIC

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: International Multicentre Cohort Study for the Validation of CLASSIC - Classification of Intraoperative Complications

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.

The aim of this international multicentre observational cohort study is to assess the validity and practicability of this newly derived classification system CLASSIC 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.


Detailed Summary:

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
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: intraoperative complications according to CLASSIC [ Time Frame: during surgery (intraoperatively) ]

All intraoperative complications are recorded and classified according to their severity


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: December 19, 2016
Date Started: February 15, 2017
Date Completion: December 2017
Last Updated: April 27, 2017
Last Verified: April 2017