Validation Study of ClassIntra®
Completed
Conditions studied: Patient Safety, Intraoperative Complications, Postoperative Complications, Risk Management
In brief
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.
Key facts
- Study ID
- NCT03009929
- Run by
- University Hospital, Basel, Switzerland
- People needed
- 2500
- Starts
- 2017-02-15
- Expected to finish
- 2018-08-31
- Last updated by the study team
- 2019-10-17
Who can join
Age: any, up to 110. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
You may not qualify if…
- 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)
Where it is running
- Trinity College Dublin at Tallaght — Dublin, Ireland
- National Cancer Institute — Naples, Italy
- 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, 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
- Carolinas Healthcare System — Charlotte, North Carolina, 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
Full record on ClinicalTrials.gov
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