Communication Research Clinical Trial
— StOP?Official title:
STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room
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.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | For the clusters (surgeons) Inclusion Criteria: - Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Bern University Hospital (Inselspital) | Bern | BE |
Switzerland | Hôpital Fribourgeois | Fribourg | FR |
Switzerland | Centre Hospitalier Universitaire Vaudois (CHUV) | Lausanne | Vaud |
Switzerland | Kantonsspital Baselland | Liestal | BL |
Switzerland | Spital Limmattal | Schlieren | ZH |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern | Fachhochschule Nordwestschweiz, Swiss National Science Foundation, University of Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Surgical site infections (SSI) within 30 days after the index operation | Surgical site infections as defined by the Centers for Disease Control and Prevention (CDC) and collected by Swissnoso (a national surveillance programme for surgical site infections in Switzerland) in the intervention arm compared to the control arm. Note. SSI will be collected only for a pragmatic subsample of patients | 30 days after the index operation | |
Primary | Mortality within 30 days after the operation | Mortality within 30 days after the operation in the intervention arm compared to the control arm | 30 days after the index operation | |
Secondary | Unplanned reoperations within 30 days after the operation | Unplanned reoperations within 30 days after the operation in the intervention arm compared to the control arm | 30 days after the index operation | |
Secondary | Length of hospital stay | Length of hospital stay in the intervention arm compared to the control arm | It is reasonable to estimate that the information will be available after 60 post-operative days for most patients | |
Secondary | Unplanned hospital readmissions within 30 days after the operation | Unplanned hospital readmissions within 30 days after the operation in the intervention arm compared to the control arm | 30 days after the index operation |
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