Validation Study of ClassIntra®

NCT03009929 | Completed

• 1 other identifier: 2016-00469
• Study Type: observational
• Target: 2,500
• Locations: 11 countries
• Sites: 17

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.

Conditions

Patient Safety; Intraoperative Complications; Postoperative Complications; Risk Management

Outcome Measures

Primary Outcomes (1)

• intraoperative complications according to ClassIntra®

  All intraoperative complications are recorded and classified according to their severity

  during surgery (intraoperatively)

Secondary Outcomes (6)

• in-hospital postoperative complications

  From after surgery up to hospital discharge, timeframe up to 30 days

• Duration of surgery

  From start to the end of the surgical procedure

• Complexity of main surgical procedure

  Baseline

• in-hospital mortality

  From after surgery up to hospital discharge, timeframe up to 30 days

• 30-day mortality

  30 days postoperatively

Interventions

Observational study OTHER

No intervention, observational only

Also known as: No intervention, observational only

Eligibility Criteria

• Age: Up to 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement

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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (18)

Carolinas Healthcare System

Charlotte, North Carolina, 28204, United States

Location

Northern Sydney Colorectal Clinic

Sydney, Australia

Location

Medical University of Innsbruck

Innsbruck, Austria

Location

Barmherzige Brüder Krankenhaus

Vienna, Austria

Location

Medical School, Aristotle University Thessaloniki

Thessaloniki, Greece

Location

Trinity College Dublin at Tallaght

Dublin, Ireland

Location

National Cancer Institute

Naples, Italy

Location

Radboud University Medical Centre

Nijmegen, Netherlands

Location

Auckland City Hospital

Auckland, New Zealand

Location

Hospital Valle de Hebron

Barcelona, Spain

Location

University Hopsital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

University Childrens Hospital Basel

Basel, Switzerland

Location

Kantonsspital Graubünden

Chur, Switzerland

Location

University Hospital Lausanne

Lausanne, Switzerland

Location

Bürgerspital Solothurn

Solothurn, Switzerland

Location

Schulthess Clinique Zurich

Zurich, Switzerland

Location

Ankara University Medical School

Ankara, Turkey (Türkiye)

Location

Guy's and St. Thomas Hospital

London, United Kingdom

Location

Related Publications (2)

• Gawria L, Rosenthal R, van Goor H, Dell-Kuster S; ClassIntra Study Group. Classification of intraoperative adverse events in visceral surgery. Surgery. 2022 Jun;171(6):1570-1579. doi: 10.1016/j.surg.2021.12.011. Epub 2022 Feb 15.

  PMID: 35177252 DERIVED

• Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.

  PMID: 32843333 DERIVED

MeSH Terms

Conditions

Intraoperative Complications; Postoperative Complications

Interventions

Observation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Salome Dell-Kuster, MD MSc

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2016
• First Posted: January 4, 2017
• Study Start: February 15, 2017
• Primary Completion: July 6, 2018
• Study Completion: August 31, 2018
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

AU (2); NL (1); US (1); IE (1); TU (1); GB (1); GR (1); CH (6); IT (1); NZ (1); ES (1)