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STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room | Clinical Trials | Clareo Health

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

STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room

NCT05356962•Insel Gruppe AG, University Hospital Bern

View on ClinicalTrials.gov

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 the operation, the Objectives of the next steps and the potential Problems the surgical team may meet; the responsible surgeon encourages the team to voice any question or concern (?). To test the impact of the StOP?-protocol on patient outcomes, the study is designed as a randomized controlled trial. Surgeons will be randomized either (a) in the intervention group and be trained to perform the StOP?-protocol or (b) in the control group and will communicate as they prefer during their operations. Post-operative patient outcomes of the surgeons in the intervention and the control group will be compared to evaluate the effects of the StOP?-protocol.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For the clusters (surgeons)
•Board-certified surgeons with specialization in one of the following disciplines: general, visceral, thoracic, vascular surgery, surgical urology, or gynecology.
•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

•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:
•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

Locations (13)

Tirol Kliniken GmbH

Innsbruck, Austria

Kantonsspital Baselland

Liestal, Basel-Landschaft, Switzerland

Kantonsspital Baden AG

Baden, Canton of Aargau, Switzerland

Bern University Hospital (Inselspital)

Bern, Canton of Bern, Switzerland

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

EOC Civico Lugano and EOC ospedale regionale di Bellinzona

Lugano, Canton Ticino, Switzerland

Key Dates

Start Date

August 1, 2022

Primary Completion Date

April 30, 2026

Completion Date

April 30, 2026

Last Updated

November 18, 2025

Enrollment

400

ESTIMATED participants

Conditions

Communication ResearchCommunication, Multidisciplinary

Interventions

StOP?-protocol

BEHAVIORAL

Contacts

Guido Beldi, MD

CONTACT

+41 31 63 2 48 18 guido.beldi@insel.ch

Sandra Keller, PhD

CONTACT

+41 31 66 4 21 76 sandra.keller@dbmr.unibe.ch

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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