Patient SafetyClassIntra®NCT03009929
Validation Study of ClassIntra®
An observational study of Patient Safety and Intraoperative Complications, run by University Hospital, Basel, Switzerland at 18 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 110 years
- Conditions the study is for
- Patient Safety, Intraoperative Complications, Postoperative Complications
- What is being tested?
- Observational study
- How many people
- 2,500 participants
- Where
- 18 sitesin 12 countries
- Study dates
- 15 Feb 2017to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 110 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Who may be able to join
- All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Who cannot join
- 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)
Trial locations and contacts
18 sites in 12 countries.
18 sites in 12 countries
Switzerland6 sites
University Hopsital Basel
Basel, Canton of Basel-City, 4031
University Childrens Hospital Basel
Basel
Kantonsspital Graubünden
Chur
University Hospital Lausanne
Lausanne
Bürgerspital Solothurn
Solothurn
Schulthess Clinique Zurich
Zurich
Austria2 sites
Medical University of Innsbruck
Innsbruck
Barmherzige Brüder Krankenhaus
Vienna
United States1 site
Carolinas Healthcare System
Charlotte, North Carolina, 28204
About this study
Official title: International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events
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
- Being tested
- Observational study
- Medical subject headings
- Intraoperative Complications, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
Also called No intervention, observational only
No intervention, observational only
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative complications according to ClassIntra®
All intraoperative complications are recorded and classified according to their severity
Measured: during surgery (intraoperatively)
Secondary outcomes (6)
in-hospital postoperative complications
All postoperative complications observed during the hospital stay are recorded and classified according to their severity
Measured: From after surgery up to hospital discharge, timeframe up to 30 days
Duration of surgery
Time from start to end of the surgical procedure
Measured: From start to the end of the surgical procedure
Complexity of main surgical procedure
Complexity according to British United Provident Association (BUPA) classification
Measured: Baseline
in-hospital mortality
Measured: From after surgery up to hospital discharge, timeframe up to 30 days
30-day mortality
Measured: 30 days postoperatively
Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start15 Feb 2017
- Primary completion6 Jul 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient SafetyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salome Dell-Kuster, MD MSc, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009929
- Sponsor's protocol ID
- 2016-00469
- Other IDs
- 2016
- Acronym
- ClassIntra®
- Status last verified
- Oct 2019
- First submitted
- 19 Dec 2016
- Last updated
- 17 Oct 2019
- Results posted
- No
Publications
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.
PubMed 35177252Dell-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.
PubMed 32843333
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Multicentre Cohort Study for the External Validation of ClassIntra® - Classification of Intraoperative Adverse Events
- ClinicalTrials.gov ID
- NCT03009929
- Acronym / sponsor ID
- ClassIntra® / 2016-00469
- Conditions
- Patient Safety, Intraoperative Complications, Postoperative Complications, Risk Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Key inclusion criteria (1 listed)
- All in-hospital patients (consecutive or random sample) undergoing surgery in the operating room with anaesthesia involvement
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational studyAlso: No intervention, observational onlyNo intervention, observational only | Other | – |
Primary outcome
intraoperative complications according to ClassIntra®
Time frame: during surgery (intraoperatively)
All intraoperative complications are recorded and classified according to their severity
6 secondary outcomes
in-hospital postoperative complications
Time frame: From after surgery up to hospital discharge, timeframe up to 30 days
Duration of surgery
Time frame: From start to the end of the surgical procedure
Complexity of main surgical procedure
Time frame: Baseline
in-hospital mortality
Time frame: From after surgery up to hospital discharge, timeframe up to 30 days
30-day mortality
Time frame: 30 days postoperatively
Agreement in assessment of intraoperative complications between several raters using fictitious clinical case-scenarios using a questionnaire among physicians
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Derived from this study: PubMed 35177252Gawria 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.
- Derived from this study: PubMed 32843333Dell-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salome Dell-Kuster, MD MSc principal investigator
University Hospital, Basel, Switzerland
18 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Safety and Intraoperative Complications, run by University Hospital, Basel, Switzerland at 18 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Switzerland, Austria, United States, Australia, Greece and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative complications according to ClassIntra® (time frame: during surgery (intraoperatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009929, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019; AzTrials last refreshed its copy on 27 Oct 2026.