STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
Recruiting now · Not applicable
Conditions studied: Communication Research, Communication, Multidisciplinary
In brief
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.
Key facts
- Study ID
- NCT05356962
- Run by
- Insel Gruppe AG, University Hospital Bern
- People needed
- 400
- Starts
- 2022-08-01
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2025-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.
You may not qualify if…
- 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
Where it is running
- Kantonsspital Baselland — Liestal, Basel-Landschaft, Switzerland (enrolling)
- EOC Civico Lugano and EOC ospedale regionale di Bellinzona — Lugano, Canton Ticino, Switzerland (enrolling)
- Tirol Kliniken GmbH — Innsbruck, Austria (enrolling)
- Hôpital Fribourgeois — Fribourg, Canton of Fribourg, Switzerland
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland
- Spital Limmattal — Schlieren, Canton of Zurich, Switzerland
- Kantonsspital Winterthur — Winterthur, Canton of Zurich, Switzerland
- Stadtspital Zürich Triemli — Zurich, Canton of Zurich, Switzerland
- Kantonsspital Graubünden — Chur, Kanton Graubünden, Switzerland
- Spital Thurgau — Frauenfeld, Thurgau, Switzerland
- Réseau hospitalier neuchâtelois — Neuchâtel, Switzerland
- Kantonsspital Baden AG — Baden, Canton of Aargau, Switzerland
- Bern University Hospital (Inselspital) — Bern, Canton of Bern, Switzerland
Full record on ClinicalTrials.gov
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