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ClassIntra®
International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events
Sponsor study identifier
Secondary identifiers
NIH
observational
2,500
12 countries
18
Study Start
February 15, 2017
Actual (reported)Primary Completion
July 6, 2018
Actual (reported)Study Completion
August 31, 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 31, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2016
Actual (reported)January 4, 2017
Actual (reported)February 15, 2017
Actual (reported)July 6, 2018
Actual (reported)August 31, 2018
Actual (reported)intraoperative complications according to ClassIntra®
All intraoperative complications are recorded and classified according to their severity
during surgery (intraoperatively)
in-hospital postoperative complications
From after surgery up to hospital discharge, timeframe up to 30 days
Duration of surgery
From start to the end of the surgical procedure
Complexity of main surgical procedure
Baseline
in-hospital mortality
From after surgery up to hospital discharge, timeframe up to 30 days
30-day mortality
30 days postoperatively
No intervention, observational only
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Carolinas Healthcare System
Charlotte, North Carolina, 28204, 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
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, Ioannidis O, 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.
Salome Dell-Kuster, MD MSc
University Hospital, Basel, Switzerland
2,500 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2016
First Posted
January 4, 2017
Study Start
February 15, 2017
Actual (reported)Contact the study team to confirm eligibility.
Radboud University Medical Centre
Nijmegen, Netherlands
Auckland City Hospital
Auckland, New Zealand
Hospital Valle de Hebron
Barcelona, Spain
University Hopsital Basel
Basel, Canton of Basel-City, 4031, Switzerland
University Childrens Hospital Basel
Basel, Switzerland
Kantonsspital Graubünden
Chur, Switzerland
University Hospital Lausanne
Lausanne, Switzerland
Bürgerspital Solothurn
Solothurn, Switzerland
Schulthess Clinique Zurich
Zurich, Switzerland
Ankara University Medical School
Ankara, Turkey (Türkiye)
Guy's and St. Thomas Hospital
London, United Kingdom
Primary Completion
July 6, 2018
Actual (reported)Study Completion
August 31, 2018
Actual (reported)Last Updated
October 17, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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