What is the StOP?-protocol studying for communication in surgery?

The StOP?-protocol is being studied to see how a structured communication briefing led by surgeons during operations affects patient outcomes like post-operative mortality. Researchers want to understand if this team briefing can improve safety and results in the operating room. The study is led by Insel Gruppe AG and University Hospital Bern.

Who may be eligible for this communication research clinical trial?

Adults aged 18 or older operated on by participating surgeons may be eligible. The trial includes patients who provide general consent for use of their healthcare data. Surgeons must be board-certified in certain surgical specialties and not already using this protocol. Please review eligibility criteria for more details.

Is there any cost to participate in this communication research clinical trial?

Study-related care, including data collection and all trial visits, is provided at no cost. Personal travel or related expenses may vary and are not guaranteed to be covered. Participants can expect that the trial covers all study procedures without charge.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID05356962

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

Led by Insel Gruppe AG, University Hospital Bern · Updated on 2025-11-18

400

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of the StOP?-protocol, a structured communication briefing used by surgeons during operations, on post-operative mortality and other important patient outcomes. This randomized controlled trial aims to compare patient outcomes between surgeons trained in the StOP?-protocol and those who communicate as usual during surgery. The study focuses on improving communication in the operating room to potentially enhance patient safety and surgical results. Surgeons in the intervention group will receive multi-module training to perform the StOP?-protocol during all their operations over a 4-month period. This briefing involves the surgeon informing the team about the current status of the operation, the goals for the next steps, and any potential problems, while encouraging questions or concerns from the team. Surgeons in the control group will continue their usual communication practices without this structured briefing. Participants include patients operated on by the cluster surgeons during the study period. Researchers will assess outcomes such as mortality within 30 days after surgery, unplanned reoperations, length of hospital stay, and unplanned hospital readmissions within 30 days. Patient data will be collected based on general consent or relevant legal provisions. The study will monitor these outcomes to evaluate the effects of implementing the StOP?-protocol in surgical practice.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Board-certified surgeons specialized in general, visceral, thoracic, vascular surgery, surgical urology, or gynecology
Patients operated on by participating cluster surgeons during the study period
Patients who have given general consent for the use of their healthcare-related data
Adults aged 18 years or older

You will not qualify if you...

Surgeons already performing the StOP?-protocol
Surgeons previously enrolled in the StOP?-II trial
Patients younger than 18 years
Patients with previous operation at the same site within 30 days prior to the index operation
Procedures not performed in operating rooms (e.g., outpatient clinics, wards)
Mainly diagnostic endoscopic procedures (e.g., colonoscopy, gastroscopy, bronchoscopy)
Percutaneous interventions (e.g., transurethral interventions)
Patients who have refused the use of their healthcare-related data

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Inpatient Treatment

Duration - 4 months

Participants undergo surgery during which surgeons in the intervention group perform a structured communication protocol called the StOP?-protocol to improve team briefing and communication in the operating room.

Multiple surgical operations during the study period

Post-operative Follow-up

Duration - Up to 60 days after surgery

Participants are monitored for patient outcomes such as mortality, unplanned reoperations, length of hospital stay, and hospital readmissions within 30 to 60 days after surgery.

Follow-up visits as part of standard post-operative care

Trial Site Locations

Total: 13 locations

Tirol Kliniken GmbH

Innsbruck, Austria, 6020

Actively Recruiting

Kantonsspital Baselland

Liestal, Basel-Landschaft, Switzerland, 4410

Actively Recruiting

Kantonsspital Baden AG

Baden, Canton of Aargau, Switzerland, 5404

Active, Not Recruiting

Bern University Hospital (Inselspital)

Bern, Canton of Bern, Switzerland, 3008

Active, Not Recruiting

Hôpital Fribourgeois

Fribourg, Canton of Fribourg, Switzerland, 1708

Active, Not Recruiting

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, Switzerland, 1000

Active, Not Recruiting

Spital Limmattal

Schlieren, Canton of Zurich, Switzerland, 8952

Active, Not Recruiting

Kantonsspital Winterthur

Winterthur, Canton of Zurich, Switzerland, 8400

Active, Not Recruiting

Stadtspital Zürich Triemli

Zurich, Canton of Zurich, Switzerland, 8063

Active, Not Recruiting

EOC Civico Lugano and EOC ospedale regionale di Bellinzona

Lugano, Canton Ticino, Switzerland, 6900

Actively Recruiting

Kantonsspital Graubünden

Chur, Kanton Graubünden, Switzerland, 7000

Active, Not Recruiting

Spital Thurgau

Frauenfeld, Thurgau, Switzerland, 8501

Active, Not Recruiting

Réseau hospitalier neuchâtelois

Neuchâtel, Switzerland, 2000

Active, Not Recruiting

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Research Team

Guido Beldi, MD

Sandra Keller, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

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