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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05356962
Other study ID # 2021-02433
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2022
Est. completion date April 30, 2026

Study information

Verified date September 2023
Source Insel Gruppe AG, University Hospital Bern
Contact Guido Beldi, MD
Phone +41 31 63 2 48 18
Email guido.beldi@insel.ch
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date April 30, 2026
Est. primary completion date April 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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: 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 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: - 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


Intervention

Behavioral:
StOP?-protocol
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).

Locations

Country Name City State
Switzerland Bern University Hospital (Inselspital) Bern BE
Switzerland Hôpital Fribourgeois Fribourg FR
Switzerland Centre Hospitalier Universitaire Vaudois (CHUV) Lausanne Vaud
Switzerland Kantonsspital Baselland Liestal BL
Switzerland Spital Limmattal Schlieren ZH

Sponsors (4)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern Fachhochschule Nordwestschweiz, Swiss National Science Foundation, University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Surgical site infections (SSI) within 30 days after the index operation Surgical site infections as defined by the Centers for Disease Control and Prevention (CDC) and collected by Swissnoso (a national surveillance programme for surgical site infections in Switzerland) in the intervention arm compared to the control arm. Note. SSI will be collected only for a pragmatic subsample of patients 30 days after the index operation
Primary 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 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 30 days after the index operation
Secondary Length of hospital stay Length of hospital stay in the intervention arm compared to the control arm It is reasonable to estimate that the information will be available after 60 post-operative days for most patients
Secondary 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 30 days after the index operation
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