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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03009929




Registration number
NCT03009929
Ethics application status
Date submitted
19/12/2016
Date registered
4/01/2017
Date last updated
17/10/2019

Titles & IDs
Public title
Validation Study of ClassIntra®
Scientific title
International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events
Secondary ID [1] 0 0
2016-00469
Universal Trial Number (UTN)
Trial acronym
ClassIntra®
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient Safety 0 0
Intraoperative Complications 0 0
Postoperative Complications 0 0
Risk Management 0 0
Condition category
Condition code
Surgery 0 0 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Observational study

Other interventions: Observational study
No intervention, observational only
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
intraoperative complications according to ClassIntra®
Timepoint [1] 0 0
during surgery (intraoperatively)
Secondary outcome [1] 0 0
in-hospital postoperative complications
Timepoint [1] 0 0
From after surgery up to hospital discharge, timeframe up to 30 days
Secondary outcome [2] 0 0
Duration of surgery
Timepoint [2] 0 0
From start to the end of the surgical procedure
Secondary outcome [3] 0 0
Complexity of main surgical procedure
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
in-hospital mortality
Timepoint [4] 0 0
From after surgery up to hospital discharge, timeframe up to 30 days
Secondary outcome [5] 0 0
30-day mortality
Timepoint [5] 0 0
30 days postoperatively
Secondary outcome [6] 0 0
Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians
Timepoint [6] 0 0
Baseline

Eligibility
Key inclusion criteria
* All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Minimum age
No limit
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/08/2018
Sample size
Target
Accrual to date
Final
2500
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Northern Sydney Colorectal Clinic - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Greece
State/province [4] 0 0
Thessaloniki
Country [5] 0 0
Ireland
State/province [5] 0 0
Dublin
Country [6] 0 0
Italy
State/province [6] 0 0
Naples
Country [7] 0 0
Netherlands
State/province [7] 0 0
Nijmegen
Country [8] 0 0
New Zealand
State/province [8] 0 0
Auckland
Country [9] 0 0
Spain
State/province [9] 0 0
Barcelona
Country [10] 0 0
Switzerland
State/province [10] 0 0
Basel Stadt
Country [11] 0 0
Switzerland
State/province [11] 0 0
Basel
Country [12] 0 0
Switzerland
State/province [12] 0 0
Chur
Country [13] 0 0
Switzerland
State/province [13] 0 0
Lausanne
Country [14] 0 0
Switzerland
State/province [14] 0 0
Solothurn
Country [15] 0 0
Switzerland
State/province [15] 0 0
Zürich
Country [16] 0 0
Turkey
State/province [16] 0 0
Ankara
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital, Basel, Switzerland
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03009929
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Salome Dell-Kuster, MD MSc
Address 0 0
University Hospital, Basel, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03009929