Clinical trial NCT03009929: Validation Study of ClassIntra®
Official title: International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Intraoperative Complications
Postoperative Complications
Risk Management
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 2500
Sex: ALL
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement

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. 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.


Eligibility 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)

Primary outcomes:
measure: intraoperative complications according to ClassIntra®
timeFrame: during surgery (intraoperatively)
Secondary outcomes:
measure: in-hospital postoperative complications
timeFrame: From after surgery up to hospital discharge, timeframe up to 30 days
measure: Duration of surgery
timeFrame: From start to the end of the surgical procedure
measure: Complexity of main surgical procedure
timeFrame: Baseline
measure: in-hospital mortality
timeFrame: From after surgery up to hospital discharge, timeframe up to 30 days
measure: 30-day mortality
timeFrame: 30 days postoperatively
measure: Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians
timeFrame: Baseline
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Sydney
country: Australia
facility: Northern Sydney Colorectal Clinic
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Wien
country: Austria
facility: Barmherzige Brüder Krankenhaus
city: Thessaloniki
country: Greece
facility: Medical School, Aristotle University Thessaloniki
city: Dublin
country: Ireland
facility: Trinity College Dublin at Tallaght
city: Naples
country: Italy
facility: National Cancer Institute
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Barcelona
country: Spain
facility: Hospital Valle de Hebron
city: Basel
country: Switzerland
facility: University Hopsital Basel
state: Basel Stadt
city: Basel
country: Switzerland
facility: University Childrens Hospital Basel
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden
city: Lausanne
country: Switzerland
facility: University Hospital Lausanne
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn
city: Zürich
country: Switzerland
facility: Schulthess Clinique Zurich
city: Ankara
country: Turkey
facility: Ankara University Medical School
city: London
country: United Kingdom
facility: Guy's and St. Thomas Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Salome Dell-Kuster, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.