Validation Study of ClassIntra®

Postoperative Complications Clinical Trial

— ClassIntra®  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009929
• Other study ID #: 2016-00469
• Status: Completed
• Start date: February 15, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: August 31, 2018
• Est. primary completion date: July 6, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 110 Years

Eligibility

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)

Related Conditions & MeSH terms

• Intraoperative Complications
• Patient Safety
• Postoperative Complications
• Risk Management

Intervention

Other:
• Observational study
No intervention, observational only

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Greece,  Ireland,  Italy,  Netherlands,  New Zealand,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraoperative complications according to ClassIntra®	All intraoperative complications are recorded and classified according to their severity	during surgery (intraoperatively)
Secondary	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
Secondary	Duration of surgery	Time from start to end of the surgical procedure	From start to the end of the surgical procedure
Secondary	Complexity of main surgical procedure	Complexity according to British United Provident Association (BUPA) classification	Baseline
Secondary	in-hospital mortality		From after surgery up to hospital discharge, timeframe up to 30 days
Secondary	30-day mortality		30 days postoperatively
Secondary	Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians		Baseline