Validation Study of ClassIntra®

University Hospital, Basel, Switzerland2,500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,500

Conditions

Patient Safety Intraoperative Complications Postoperative Complications Risk Management

Eligibility

Sex: ALLMax age: 110 Years

Medical Language ↔ Plain English

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)

Locations (18)

Carolinas Healthcare System

Charlotte, North Carolina, United States

Northern Sydney Colorectal Clinic

Sydney, Australia

Medical University of Innsbruck

Innsbruck, Austria

Barmherzige Brüder Krankenhaus

Vienna, Austria

Medical School, Aristotle University Thessaloniki

Thessaloniki, Greece

Trinity College Dublin at Tallaght

Dublin, Ireland

National Cancer Institute

Naples, Italy

Radboud University Medical Centre

Nijmegen, Netherlands

Auckland City Hospital

Auckland, New Zealand

Hospital Valle de Hebron

Barcelona, Spain

...and 8 more locations

Outcomes

Primary Outcomes

intraoperative complications according to ClassIntra®

All intraoperative complications are recorded and classified according to their severity

Time frame: during surgery (intraoperatively)

Secondary Outcomes

in-hospital postoperative complications

All postoperative complications observed during the hospital stay are recorded and classified according to their severity

Time frame: From after surgery up to hospital discharge, timeframe up to 30 days

Duration of surgery

Time from start to end of the surgical procedure

Time frame: From start to the end of the surgical procedure

Complexity of main surgical procedure

Complexity according to British United Provident Association (BUPA) classification

Time frame: Baseline

in-hospital mortality