Validation Study of ClassIntra®

NCT ID: NCT03009929

Last Updated: 2019-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2018-08-31

Brief Summary

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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

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Conditions

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Patient Safety Intraoperative Complications Postoperative Complications Risk Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Observational study

No intervention, observational only

Intervention Type OTHER

Other Intervention Names

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No intervention, observational only

Eligibility Criteria

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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)
Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Salome Dell-Kuster, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Carolinas Healthcare System

Charlotte, North Carolina, United States

Site Status

Northern Sydney Colorectal Clinic

Sydney, , Australia

Site Status

Medical University of Innsbruck

Innsbruck, , Austria

Site Status

Barmherzige Brüder Krankenhaus

Vienna, , Austria

Site Status

Medical School, Aristotle University Thessaloniki

Thessaloniki, , Greece

Site Status

Trinity College Dublin at Tallaght

Dublin, , Ireland

Site Status

National Cancer Institute

Naples, , Italy

Site Status

Radboud University Medical Centre

Nijmegen, , Netherlands

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Hospital Valle de Hebron

Barcelona, , Spain

Site Status

University Hopsital Basel

Basel, Canton of Basel-City, Switzerland

Site Status

University Childrens Hospital Basel

Basel, , Switzerland

Site Status

Kantonsspital Graubünden

Chur, , Switzerland

Site Status

University Hospital Lausanne

Lausanne, , Switzerland

Site Status

Bürgerspital Solothurn

Solothurn, , Switzerland

Site Status

Schulthess Clinique Zurich

Zurich, , Switzerland

Site Status

Ankara University Medical School

Ankara, , Turkey (Türkiye)

Site Status

Guy's and St. Thomas Hospital

London, , United Kingdom

Site Status

Countries

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

References

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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.

Reference Type DERIVED
PMID: 35177252 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32843333 (View on PubMed)

Other Identifiers

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2016-00469

Identifier Type: -

Identifier Source: org_study_id

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