STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Apr 26, 2022

Keywords

ClinConnect Summary

The STOP? II trial is studying how a special communication method called the StOP?-protocol can improve discussions among surgical teams during operations and how it affects patient outcomes, such as survival rates after surgery. This protocol involves a structured briefing before surgery that aims to ensure everyone is on the same page, which could lead to better results for patients.

To participate in this study, surgeons must be board-certified and specialize in certain types of surgery, such as general or gynecological surgery. Patients who are eligible for this trial are those who will be operated on by these surgeons during specific times and have given general consent for their health data to be used. However, patients must be at least 18 years old and not have had a surgery at the same location in the last 30 days. If you decide to participate, you can expect that the surgical team will follow a structured communication process during your operation, which researchers hope will lead to improved outcomes.

Gender

ALL

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