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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03009929
Other study ID # 2016-00469
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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)

Study Design


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
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