ClassIntra® for Better Outcomes in Surgery - CIBOSurg

NCT ID: NCT05818332

Last Updated: 2025-02-11

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

RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-17

Study Completion Date

2027-07-31

Brief Summary

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Intra- and postoperative adverse events (iAEs and pAEs) occur in up to one third of all patients undergoing surgery. They are devastating to patients and costly to health care systems. Their number tends to increase due to the rising complexity of both the patient's risk profile and the surgical procedure. Postoperative deaths have been identified to be the third most frequent cause of death worldwide. Teamwork in surgery has been attributed to have a potentially great impact on avoiding postoperative morbidity. Up to 50% of all adverse in-hospital events were rated to be potentially preventable. However, their prevention typically requires a change in systems and individual behaviour. Standardised assessments of iAEs and pAEs are a prerequisite to develop and define strategies for prevention of AEs. While awareness of pAEs has highly risen through the introduction of the Clavien-Dindo classification, the most widely used classification for grading severity of pAEs, the relevance of transparent monitoring of iAEs is still highly undervalued.

Detailed Description

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Conditions

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Perioperative Patient Safety

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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before and after implementation cohort

consecutive cohort of 900 surgical patients (baseline)

consecutive cohort of 900 surgical patients (after implementation with a multifaceted, tailored implementation strategy to improve adherence to the WHO SSC and routine recording of iAEs)

Observational study

Intervention Type OTHER

No intervention, observational only

Interventions

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Observational study

No intervention, observational only

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

\- All in-hospital patients (consecutive or random sample) undergoing surgery from general surgery, vascular, surgery, orthopaedics/traumatology and urology in the operating room with anaesthesia involvement

Exclusion Criteria

* Patients undergoing one-day-surgery (with or without anaesthesia-involvement)
* Procedures without anaesthesia-involvement (in- or out-patient)
* ASA risk classification (ASA) VI patients (brain-death, organ-donor)
* Follow-up procedure of a patient already included in the study
Minimum Eligible Age

18 Years

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

Locations

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Radboud UMC

Nijmegen, , Netherlands

Site Status WITHDRAWN

University Hospital Basel

Basel, , Switzerland

Site Status COMPLETED

Lindenhofspital

Bern, , Switzerland

Site Status RECRUITING

University Hospital Berne

Bern, , Switzerland

Site Status RECRUITING

Cantonal Hospital Graubünden

Chur, , Switzerland

Site Status RECRUITING

University Hospital Geneva

Geneva, , Switzerland

Site Status RECRUITING

University Hospital Lausanne

Lausanne, , Switzerland

Site Status RECRUITING

Cantonal Hospital Lucerne

Lucerne, , Switzerland

Site Status RECRUITING

Regional Hospital Lugano

Lugano, , Switzerland

Site Status RECRUITING

University Hospital Zurich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Netherlands Switzerland

Central Contacts

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Salome Dell-Kuster, Prof. Dr. med.

Role: CONTACT

+41 61 328 64 74

Facility Contacts

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Judith Winkens

Role: primary

+41 31 366 39 89

Andreas Vogt, Prof. Dr. med.

Role: primary

+41 31 632 42 17

Gianluca Ursprung, Dipl. med.

Role: primary

+41 81 256 69 32

Guy Haller, Prof. Dr. med.

Role: primary

Dieter Hahnloser, Prof. Dr. med.

Role: primary

+41 21 314 66 31

Markus Gass, Dr. med.

Role: primary

+41 41 205 45 39

Giorgio Prouse, Dr. med.

Role: primary

+41 91 811 66 03

Valentin Neuhaus, Prof. Dr. med.

Role: primary

+41 44 255 23 99

Other Identifiers

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Req-2023-00330

Identifier Type: -

Identifier Source: org_study_id

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