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 type | Observational |
|---|---|
| Ages | 18 Years to 110 Years |
| Sex | All |
| Enrollment | 1800 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 10 sites (Nijmegen and 9 other locations) |
| Status | Recruiting |
| Started | July 17, 2023 |
| Main results expected | December 2025 |
| Study ends | July 2027 |
| Registry record updated | February 11, 2025 |
| Trial ID | NCT05818332 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
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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
- Study coordinator: Salome Dell-Kuster, Prof. Dr. med.
- Email: salome.dell-kuster@usb.ch
- Phone: +41 61 328 64 74
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.