ClassIntra® for Better Outcomes in Surgery - CIBOSurg

Last updated: February 10, 2025
Sponsor: University Hospital, Basel, Switzerland
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Observational study

Clinical Study ID

NCT05818332
Req-2023-00330
  • Ages 18-110
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All in-hospital patients (consecutive or random sample) undergoing surgery fromgeneral surgery, vascular, surgery, orthopaedics/traumatology and urology in theoperating room with anaesthesia involvement

Exclusion

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

Study Design

Total Participants: 1800
Treatment Group(s): 1
Primary Treatment: Observational study
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Radboud UMC

    Nijmegen,
    Netherlands

    Site Not Available

  • University Hospital Basel

    Basel,
    Switzerland

    Completed

  • University Hospital Berne

    Bern,
    Switzerland

    Active - Recruiting

  • Lindenhofspital

    Berne,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Graubünden

    Chur,
    Switzerland

    Active - Recruiting

  • University Hospital Geneva

    Geneva,
    Switzerland

    Active - Recruiting

  • University Hospital Lausanne

    Lausanne,
    Switzerland

    Active - Recruiting

  • Cantonal Hospital Lucerne

    Lucerne,
    Switzerland

    Active - Recruiting

  • Regional Hospital Lugano

    Lugano,
    Switzerland

    Active - Recruiting

  • University Hospital Zurich

    Zürich,
    Switzerland

    Active - Recruiting

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