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Validation Study of ClassIntra®

NCT03009929 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2500

Last updated 2019-10-17

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Observational study

No intervention, observational only

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Salome Dell-Kuster, MD MSc · University Hospital, Basel, Switzerland

Eligibility

Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2018-07-06
Completion
2018-08-31

Countries

  • United States
  • Australia
  • Austria
  • Greece
  • Ireland
  • Italy
  • Netherlands
  • New Zealand
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009929 on ClinicalTrials.gov