NCT05356962

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

3.7 years

First QC Date

April 26, 2022

Last Update Submit

November 17, 2025

Conditions

Communication ResearchCommunication, Multidisciplinary

Keywords

CommunicationBriefingInterventionOperating roomSurgery

Outcome Measures

Primary Outcomes (1)

  • Mortality within 30 days after the operation

    Mortality within 30 days after the operation in the intervention arm compared to the control arm

    30 days after the index operation

Secondary Outcomes (3)

  • Unplanned reoperations within 30 days after the operation

    30 days after the index operation

  • Length of hospital stay

    It is reasonable to estimate that the information will be available after 60 post-operative days for most patients

  • Unplanned hospital readmissions within 30 days after the operation

    30 days after the index operation

Other Outcomes (1)

  • Surgical site infections (SSI) within 30 days after the index operation

    30 days after the index operation

Study Arms (2)

Interventional group

EXPERIMENTAL

The surgeons will undergo a multi-module training on how to use the StOP?-protocol and perform the StOP?-protocol during all their operations during a 4-month period.

Behavioral: StOP?-protocol

Control group

NO INTERVENTION

Surgeons in the control group will not be trained to the StOP?-protocol and will communicate as usual during their operations.

Interventions

StOP?-protocolBEHAVIORAL

The StOP?-protocol is an intra-operative briefing initiated by the responsible surgeon. When performing a StOP?-protocol, the surgeons inform the team present in the operating room about the Status (St) of the operation, the Objectives (O) of the operations, the potential problems (P) they may meet and encourage the team to ask questions or voice concerns (?). The responsible surgeon announces at the team timeout when they plan to perform the StOP-protocol(s).

Interventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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:
  • 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.
  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Tirol Kliniken GmbH

Innsbruck, 6020, Austria

RECRUITING

Kantonsspital Baselland

Liestal, Basel-Landschaft, 4410, Switzerland

RECRUITING

Kantonsspital Baden AG

Baden, Canton of Aargau, 5404, Switzerland

ACTIVE NOT RECRUITING

Bern University Hospital (Inselspital)

Bern, Canton of Bern, 3008, Switzerland

ACTIVE NOT RECRUITING

Hôpital Fribourgeois

Fribourg, Canton of Fribourg, 1708, Switzerland

ACTIVE NOT RECRUITING

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1000, Switzerland

ACTIVE NOT RECRUITING

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

ACTIVE NOT RECRUITING

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

ACTIVE NOT RECRUITING

Stadtspital Zürich Triemli

Zurich, Canton of Zurich, 8063, Switzerland

ACTIVE NOT RECRUITING

EOC Civico Lugano and EOC ospedale regionale di Bellinzona

Lugano, Canton Ticino, 6900, Switzerland

RECRUITING

Kantonsspital Graubünden

Chur, Kanton Graubünden, 7000, Switzerland

ACTIVE NOT RECRUITING

Spital Thurgau

Frauenfeld, Thurgau, 8501, Switzerland

ACTIVE NOT RECRUITING

Réseau hospitalier neuchâtelois

Neuchâtel, 2000, Switzerland

ACTIVE NOT RECRUITING

Related Publications (1)

  • Keller S, Tschan F, Semmer NK, Trelle S, Manser T, Beldi G. StOP? II trial: cluster randomized clinical trial to test the implementation of a toolbox for structured communication in the operating room-study protocol. Trials. 2022 Oct 18;23(1):878. doi: 10.1186/s13063-022-06775-y.

    PMID: 36258223DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Guido Beldi, MD

    Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guido Beldi, MD

CONTACT

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

Sandra Keller, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessors will be blind whether the patients were operated by a surgeon in the control or in the intervention group.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 2, 2022

Study Start

August 1, 2022

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

November 18, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

AU(1)CH(12)