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

Last updated: March 11, 2025
Sponsor: Insel Gruppe AG, University Hospital Bern
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

StOP?-protocol

Clinical Study ID

NCT05356962
2021-02433
  • Ages > 18
  • All Genders

Study 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

Inclusion

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

Exclusion Criteria:

  • Surgeons who are already performing StOP?-protocol. (Potentially, surgeons who tookpart in the first study (StOP-I) may still perform StOP?).

  • Surgeon who were previously enrolled in the StOP?-II trial (this is relevant forsurgeons who move or rotate between departments/hospitals and might therefore beworking 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 thatare the result of the patient's treatment. In case no written document from thegeneral consent is available despite documented efforts of the participating center,article 34 HRA (Swiss law) will be applied, allowing the use of thehealthcare-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

Study Design

Total Participants: 400
Treatment Group(s): 1
Primary Treatment: StOP?-protocol
Phase:
Study Start date:
August 01, 2022
Estimated Completion Date:
April 30, 2026

Study 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.

Connect with a study center

  • Tirol Kliniken GmbH

    Innsbruck, 6020
    Austria

    Active - Recruiting

  • Bern University Hospital (Inselspital)

    Bern, BE 3008
    Switzerland

    Site Not Available

  • Kantonsspital Baselland

    Liestal, BL 4410
    Switzerland

    Active - Recruiting

  • Hôpital Fribourgeois

    Fribourg, FR 1708
    Switzerland

    Site Not Available

  • Kantonsspital Graubünden

    Chur, GR 7000
    Switzerland

    Active - Recruiting

  • Spital Thurgau

    Frauenfeld, Thurgau 8501
    Switzerland

    Site Not Available

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Vaud 1000
    Switzerland

    Site Not Available

  • Spital Limmattal

    Schlieren, ZH 8952
    Switzerland

    Site Not Available

  • Kantonsspital Winterthur

    Winterthur, ZH 8400
    Switzerland

    Site Not Available

  • Stadtspital Zürich Triemli

    Zürich, ZH 8063
    Switzerland

    Site Not Available

  • Réseau hospitalier neuchâtelois

    Neuchâtel, 2000
    Switzerland

    Site Not Available

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