NCT05356962 STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
| NCT ID | NCT05356962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Communication Research |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2026-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2022-08-01 with a primary completion date of 2026-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Guido Beldi, MD
PRINCIPAL INVESTIGATOR
Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
Frequently Asked Questions
Who can join the NCT05356962 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Communication Research. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05356962 currently recruiting?
Yes, NCT05356962 is actively recruiting participants. Contact the research team at guido.beldi@insel.ch for enrollment information.
Where is the NCT05356962 trial being conducted?
This trial is being conducted at Innsbruck, Austria, Liestal, Switzerland, Baden, Switzerland, Bern, Switzerland and 9 additional locations.
Who is sponsoring the NCT05356962 clinical trial?
NCT05356962 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Guido Beldi, MD at Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland. The trial plans to enroll 400 participants.