Validation Study of ClassIntra® (ClassIntra®)

International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events

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 Overview

• Status: Completed
• Conditions: Postoperative Complications; Intraoperative Complications; Patient Safety; Risk Management
• Intervention / Treatment: Other: Observational study

• Study Type: Observational
• Enrollment (Actual): 2500

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • Northern Sydney Colorectal Clinic
• Austria
  • Innsbruck, Austria
    • Medical University of Innsbruck
  • Wien, Austria
    • Barmherzige Brüder Krankenhaus
• Greece
  • Thessaloniki, Greece
    • Medical School, Aristotle University Thessaloniki
• Ireland
  • Dublin, Ireland
    • Trinity College Dublin at Tallaght
• Italy
  • Naples, Italy
    • National Cancer Institute
• Netherlands
  • Nijmegen, Netherlands
    • Radboud University Medical Centre
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• Spain
  • Barcelona, Spain
    • Hospital Valle de Hebron
• Switzerland
  • Basel, Switzerland
    • University Childrens Hospital Basel
  • Chur, Switzerland
    • Kantonsspital Graubünden
  • Lausanne, Switzerland
    • University Hospital Lausanne
  • Solothurn, Switzerland
    • Bürgerspital Solothurn
  • Zürich, Switzerland
    • Schulthess Clinique Zurich
  • Basel Stadt
    • Basel, Basel Stadt, Switzerland, 4031
      • University Hopsital Basel
• Turkey
  • Ankara, Turkey
    • Ankara University Medical School
• United Kingdom
  • London, United Kingdom
    • Guy's and St. Thomas Hospital
• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolinas Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraoperative complications according to ClassIntra®	All intraoperative complications are recorded and classified according to their severity	during surgery (intraoperatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
in-hospital postoperative complications	All postoperative complications observed during the hospital stay are recorded and classified according to their severity	From after surgery up to hospital discharge, timeframe up to 30 days
Duration of surgery	Time from start to end of the surgical procedure	From start to the end of the surgical procedure
Complexity of main surgical procedure	Complexity according to British United Provident Association (BUPA) classification	Baseline
in-hospital mortality		From after surgery up to hospital discharge, timeframe up to 30 days
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Salome Dell-Kuster, MD MSc, University Hospital, Basel, Switzerland

Publications and helpful links

General Publications

• Gawria L, Rosenthal R, van Goor H, Dell-Kuster S; ClassIntra Study Group. Classification of intraoperative adverse events in visceral surgery. Surgery. 2022 Jun;171(6):1570-1579. doi: 10.1016/j.surg.2021.12.011. Epub 2022 Feb 15.
• Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Orestis I, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Actual): July 6, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: January 3, 2017
• First Posted (Estimate): January 4, 2017

Study Record Updates

• Last Update Posted (Actual): October 17, 2019
• Last Update Submitted That Met QC Criteria: October 15, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Intraoperative Complications
• Other Study ID Numbers: 2016-00469