Validation Study of ClassIntra®

Completed

• Conditions: Postoperative Complications; Risk Management; Patient Safety; Intraoperative Complications

• Registration Number: NCT03009929
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Study Start: 2017-02-15
• Primary Completion: 2018-07-06
• Study Completion: 2018-08-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-15
• Last Update Posted: 2019-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
intraoperative complications according to ClassIntra®	during surgery (intraoperatively)	All intraoperative complications are recorded and classified according to their severity

Secondary Outcome Measures

Name	Time	Method
in-hospital postoperative complications	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
Duration of surgery	From start to the end of the surgical procedure	Time from start to end of the surgical procedure
30-day mortality	30 days postoperatively
Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians	Baseline
Complexity of main surgical procedure	Baseline	Complexity according to British United Provident Association (BUPA) classification
in-hospital mortality	From after surgery up to hospital discharge, timeframe up to 30 days

Trial Locations

Locations (18)

Trinity College Dublin at Tallaght; 🇮🇪 Dublin, Ireland

University Hopsital Basel; 🇨🇭 Basel, Basel Stadt, Switzerland

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

University Childrens Hospital Basel; 🇨🇭 Basel, Switzerland

Carolinas Healthcare System; 🇺🇸 Charlotte, North Carolina, United States

Northern Sydney Colorectal Clinic; 🇦🇺 Sydney, Australia

Barmherzige Brüder Krankenhaus; 🇦🇹 Wien, Austria

Medical School, Aristotle University Thessaloniki; 🇬🇷 Thessaloniki, Greece

National Cancer Institute; 🇮🇹 Naples, Italy

Radboud University Medical Centre; 🇳🇱 Nijmegen, Netherlands

Auckland City Hospital; 🇳🇿 Auckland, New Zealand

Kantonsspital Graubünden; 🇨🇭 Chur, Switzerland

Guy's and St. Thomas Hospital; 🇬🇧 London, United Kingdom

Hospital Valle de Hebron; 🇪🇸 Barcelona, Spain

Bürgerspital Solothurn; 🇨🇭 Solothurn, Switzerland

Schulthess Clinique Zurich; 🇨🇭 Zürich, Switzerland

Ankara University Medical School; 🇹🇷 Ankara, Turkey

University Hospital Lausanne; 🇨🇭 Lausanne, Switzerland