Clinical trial Recruiting at 8 sites Observational Ages 18 to 110

Improving surgical outcomes with ClassIntra®

Official title: Implementation of Routine Recording of Intraoperative Adverse Events According to ClassIntra® During the Sign-out Phase of the WHO Surgical Safety Checklist Using a Multifaceted, Tailored Implementation Strategy: Protocol of a Collaborative Before- and After-cohort Project

Run by University Hospital, Basel, Switzerland · NCT05818332 · Data updated 2026-11-12

This study is testing if using ClassIntra® can help make surgeries safer by looking at problems that happen before and after surgery in patients across different types of operations.

Quick facts

Study typeObservational
Ages18 Years to 110 Years
SexAll
Enrollment1800 (estimated)
SponsorUniversity Hospital, Basel, Switzerland
Academic / other
Locations10 sites (Nijmegen and 9 other locations)
StatusRecruiting
StartedJuly 17, 2023
Main results expectedDecember 2025
Study endsJuly 2027
Registry record updatedFebruary 11, 2025
Trial IDNCT05818332 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include in-hospital patients undergoing surgery with anaesthesia involvement across various surgical specialties.

Probably not a fit

Patients undergoing one-day surgeries or procedures without anaesthesia involvement will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on enhancing perioperative patient safety by assessing intra- and postoperative adverse events (iAEs and pAEs) in patients undergoing various surgical procedures. It aims to identify the prevalence of these events and their preventability through standardized assessments and teamwork in surgical settings. By analyzing data from patients in general surgery, vascular surgery, orthopaedics, and urology, the study seeks to develop strategies to minimize adverse events and improve patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to significant improvements in patient safety and reduced postoperative complications.

How similar studies have gone: Other studies have shown that teamwork and standardized assessments can significantly reduce adverse events in surgical settings, indicating a promising approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Lindenhofspital
    Bern, Switzerland
    Recruiting
  • University Hospital Berne
    Bern, Switzerland
    Recruiting
  • Cantonal Hospital Graubünden
    Chur, Switzerland
    Recruiting
  • University Hospital Geneva
    Geneva, Switzerland
    Recruiting
  • University Hospital Lausanne
    Lausanne, Switzerland
    Recruiting
  • Cantonal Hospital Lucerne
    Lucerne, Switzerland
    Recruiting
Show 4 more locations
  • Regional Hospital Lugano
    Lugano, Switzerland
    Recruiting
  • University Hospital Zurich
    Zurich, Switzerland
    Recruiting
  • Radboud UMC
    Nijmegen, Netherlands
    Withdrawn
  • University Hospital Basel
    Basel, Switzerland
    Completed

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.