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OpenTrials
Completed

NCT Number: NCT03009929

Validation Study of ClassIntra®

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.

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Key information

Conditions

Patient Safety Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Risk Management

Age range

Up to 110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northern Sydney Colorectal Clinic, Sydney, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

observational study

Other

No intervention, observational only

Other names: No intervention, observational only

Primary outcomes

  1. intraoperative complications according to ClassIntra®

    Time frame: during surgery (intraoperatively)

    All intraoperative complications are recorded and classified according to their severity

Secondary outcomes

  1. in-hospital postoperative complications

    Time frame: From after surgery up to hospital discharge, timeframe up to 30 days

    All postoperative complications observed during the hospital stay are recorded and classified according to their severity

  2. Duration of surgery

    Time frame: From start to the end of the surgical procedure

    Time from start to end of the surgical procedure

  3. Complexity of main surgical procedure

    Time frame: Baseline

    Complexity according to British United Provident Association (BUPA) classification

  4. in-hospital mortality

    Time frame: From after surgery up to hospital discharge, timeframe up to 30 days

  5. 30-day mortality

    Time frame: 30 days postoperatively

  6. Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: ClassIntra®

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 4, 2017
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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