Communication ResearchStOP?NCT05356962
STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room
A study testing StOP?-protocol in people with Communication Research and Communication, Multidisciplinary, run by Insel Gruppe AG, University Hospital Bern at 13 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Communication Research, Communication, Multidisciplinary
- What is being tested?
- StOP?-protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Aug 2022to 19 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Mainly diagnostic endoscopic procedures (e.g. colonoscopy, gastroscopy, bronchoscopy)
- Percutaneous interventions (e.g., transurethral interventions)
- Documented refusal for the use of healthcare related data
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
Switzerland12 sites
Kantonsspital Baden AG
Baden, Canton of Aargau, 5404
Bern University Hospital (Inselspital)
Bern, Canton of Bern, 3008
Kantonsspital Graubünden
Chur, Kanton Graubünden, 7000
Spital Thurgau
Frauenfeld, Thurgau, 8501
Hôpital Fribourgeois
Fribourg, Canton of Fribourg, 1708
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1000
Kantonsspital Baselland
Liestal, Basel-Landschaft, 4410
EOC Civico Lugano and EOC ospedale regionale di Bellinzona
Lugano, Canton Ticino, 6900
Réseau hospitalier neuchâtelois
Neuchâtel, 2000
Spital Limmattal
Schlieren, Canton of Zurich, 8952
Kantonsspital Winterthur
Winterthur, Canton of Zurich, 8400
Stadtspital Zürich Triemli
Zurich, Canton of Zurich, 8063
About this study
Official title: STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room
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.
Read the 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.
- Being tested
- StOP?-protocol
- Keywords
- Communication, Briefing, Intervention, Operating room, Surgery
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StOP?-protocolBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality within 30 days after the operation
Mortality within 30 days after the operation in the intervention arm compared to the control arm
Measured: 30 days after the index operation
Secondary outcomes (3)
Unplanned reoperations within 30 days after the operation
Unplanned reoperations within 30 days after the operation in the intervention arm compared to the control arm
Measured: 30 days after the index operation
Length of hospital stay
Length of hospital stay in the intervention arm compared to the control arm
Measured: 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
Unplanned hospital readmissions within 30 days after the operation in the intervention arm compared to the control arm
Measured: 30 days after the index operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Aug 2022
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Communication ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, Fachhochschule Nordwestschweiz
- Responsible party
- Sponsor
- Investigators
- Guido Beldi, MD, Principal investigator, Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356962
- Sponsor's protocol ID
- 2021-02433
- Acronym
- StOP?
- Status last verified
- Nov 2025
- First submitted
- 26 Apr 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 36258223
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room
- ClinicalTrials.gov ID
- NCT05356962
- Acronym / sponsor ID
- StOP? / 2021-02433
- Keywords
- Communication, Briefing, Intervention, Operating room, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University of Bern, Fachhochschule Nordwestschweiz
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Behavioral: StOP?-protocolThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StOP?-protocolThe 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). | Behavioural | Interventional group |
Primary outcome
Mortality within 30 days after the operation
Time frame: 30 days after the index operation
Mortality within 30 days after the operation in the intervention arm compared to the control arm
3 secondary outcomes
Unplanned reoperations within 30 days after the operation
Time frame: 30 days after the index operation
Length of hospital stay
Time frame: 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
Time frame: 30 days after the index operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Derived from this study: PubMed 36258223Keller 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guido Beldi, MD principal investigator
Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StOP?-protocol in people with Communication Research and Communication, Multidisciplinary, run by Insel Gruppe AG, University Hospital Bern at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Switzerland, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality within 30 days after the operation (time frame: 30 days after the index operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05356962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.