Status:
RECRUITING
STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
Swiss National Science Foundation
University of Bern
Conditions:
Communication Research
Communication, Multidisciplinary
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to test the impact of the StOP?-protocol - an intra-operative communication briefing, on post-operative mortality and important patient outcomes.
Detailed Description
The StOP?-protocol is a communication briefing initiated by the responsible surgeon during a surgical operation. The surgeon informs the team present in the operating room about the current Status of ...
Eligibility Criteria
Inclusion
- For the clusters (surgeons)
- Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.
Exclusion
- Surgeons who are already performing StOP?-protocol. (Potentially, surgeons who took part in the first study (StOP-I) may still perform StOP?).
- Surgeon who were previously enrolled in the StOP?-II trial (this is relevant for surgeons who move or rotate between departments/hospitals and might therefore be working at different participating sites).
- For the patients:
- Inclusion criteria:
- Patients operated by cluster surgeons during the cluster-specific time period
- General consent from the patients, allowing the use of healthcare-related data that are the result of the patient's treatment. In case no written document from the general consent is available despite documented efforts of the participating center, article 34 HRA (Swiss law) will be applied, allowing the use of the healthcare-related patient data.
- Exclusion criteria:
- Patient age below 18 years
- Previous operation at the same site up to 30 days prior the index operation
- Procedures not done in operating rooms but in outpatient clinics, on wards, etc.
- Mainly diagnostic endoscopic procedures (e.g. colonoscopy, gastroscopy, bronchoscopy)
- Percutaneous interventions (e.g., transurethral interventions)
- Documented refusal for the use of healthcare related data
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05356962
Start Date
August 1 2022
End Date
April 30 2026
Last Update
November 18 2025
Active Locations (13)
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1
Tirol Kliniken GmbH
Innsbruck, Austria, 6020
2
Kantonsspital Baselland
Liestal, Basel-Landschaft, Switzerland, 4410
3
Kantonsspital Baden AG
Baden, Canton of Aargau, Switzerland, 5404
4
Bern University Hospital (Inselspital)
Bern, Canton of Bern, Switzerland, 3008