The STOP? II Study: Influence of Structured Intraoperative Communication on Complications After Surgeries
Summary description of the study
We will test whether the application of the StOP? protocol (communication briefings during surgical procedures) has an impact on complications after surgeries. A previous study (StOP?-I study) had already shown that the application of the StOP? protocol leads to lower mortality. Additionally, patients had to be readmitted to the hospital less frequently and could leave the hospital earlier. This StOP?-I study was conducted in a before-after design. The StOP?-II study will now examine these results in a randomized design. In the planned StOP?-II study, surgeons will be randomized into two groups. One group includes surgeons who apply the StOP? protocol during their surgeries. The surgeons in the second group communicate during surgeries as before according to the usual standards.
(BASEC)
Intervention under investigation
Our intervention consists of implementing the StOP? protocol by the responsible surgeon during surgical operations.
The StOP? protocol is a form of structured communication, a briefing, that includes the following sections: First, the surgeon explains the status of the operation (St), i.e., how far they are into the operation, then the objectives (translated from English as "objectives"), i.e., the immediate next steps. Subsequently, potential problems (P) are addressed, and finally, the surgeon asks all present in the room if anyone has a question (?).
During the implementation of the StOP? protocol, no work is done, but the present staff in the room focuses on communication and listens attentively. The protocol lasts between 30 and 90 seconds. The surgeon can choose when during the operation they would like to initiate the protocol, as surgeons know best when they can briefly interrupt their work before a critical phase of the operation to focus on communication with the team.
Four hundred surgeons will be randomly assigned to two groups. The included surgeons work at the level of senior and attending physicians, from the specialties of general surgery, visceral surgery, vascular surgery, traumatology, urology, and gynecology from Switzerland, Germany, and Austria.
The two hundred surgeons in the intervention group will be instructed by our research team on how the StOP? protocol works. They will then apply the StOP? protocol during their surgeries over a period of four months. To ensure that StOPs are indeed performed, the instrumenting nursing staff will document the implementation of the StOP? protocol at the end of the operation in a short, confidential questionnaire.
The control group consists of two hundred surgeons who communicate as usual during their operations. They will not be trained for the StOP? protocols.
Study nurses will record the mortality, reoperations, readmissions, and length of stay for all surgeries included in the study.
Once all data is collected, we will calculate using statistical methods whether the mortality rates, reoperations, readmissions, hospital stays, and wound infection rates change for patients operated on by the surgeons from the intervention group.
(BASEC)
Disease under investigation
Complications after surgical operations unfortunately occur not infrequently. These are often associated with a longer hospital stay, a reoperation, a readmission to the hospital, or a wound infection. In some cases, a difficult course after the operation can lead to the patient's death. In recent years, research has shown that not only the technical skills of surgeons and nursing staff play an important role in the occurrence of complications, but also communication within the team during a surgical procedure. The aim of our study is to investigate whether surgical postoperative complications can be altered by improved communication in the operating room.
(BASEC)
Level surgeons: - Heads or Senior Physicians - Departments of general surgery, visceral surgery, vascular surgery, traumatology, urology and gynaecology Level Operations: - Surgery will occur within the four months that the study is ongoing at a hospital (BASEC)
Exclusion criteria
Level surgeons: - Already lead StOP? through - Have previously been included in the same study (applies in case of switching between hospitals) Level Operations: - Age of patients under 18 years - Previous surgery at the same center within 30 days prior to index surgery - Operations which do not take place in an operating room - Diagnostic endoscopic interventions (e.g. colonoscopy, gastroscopy, bronchoscopy) and percutaneous interventions (e.g. transurethral interventions) - Objection to the use of health data (BASEC)
Trial sites
Bellinzona, Bern, Chur, Freiburg, Geneva, Lausanne, Lugano, Neuchatel, Winterthur, Zurich, Other
(BASEC)
Baden, la Chaux-de-Fonds, Schlieren (Spital Limmattal), Frauenfeld, Münsterlingen
(BASEC)
Sponsor
Bern University Hospital
(BASEC)
Contact
Contact Person Switzerland
Guido Beldi
+41316328275
guido.beldi@clutterinsel.chDepartment for Visceral Surgery and Medicine, Bern University Hospital, University of Bern, Switzerland
(BASEC)
General Information
Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland,
+41 31 63 2 48 18
guido.beldi@clutterinsel.ch(ICTRP)
General Information
Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland
+41 31 63 2 48 18
guido.beldi@clutterinsel.ch(ICTRP)
Scientific Information
Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland,
+41 31 63 2 48 18
guido.beldi@clutterinsel.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
14.03.2022
(BASEC)
ICTRP Trial ID
NCT05356962 (ICTRP)
Official title (approved by ethics committee)
STOP? II trial: Cluster randomized clinical trial to test the implementation of a toolbox for structured communication in the operating room (BASEC)
Academic title
STOP? II Trial: Cluster Randomized Clinical Trial to Test the Implementation of a Toolbox for Structured Communication in the Operating Room (ICTRP)
Public title
STOP? II: Testing of a Toolbox for Structured Communication in the Operating Room (ICTRP)
Disease under investigation
Communication ResearchCommunication, Multidisciplinary (ICTRP)
Intervention under investigation
Behavioral: StOP?-protocol (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
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 (ICTRP)
not available
Primary and secondary end points
Mortality within 30 days after the operation (ICTRP)
Unplanned reoperations within 30 days after the operation;Length of hospital stay;Unplanned hospital readmissions within 30 days after the operation (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Swiss National Science Foundation;University of Bern;Fachhochschule Nordwestschweiz (ICTRP)
Additional contacts
Guido Beldi, MD;Guido Beldi, MD, guido.beldi@insel.ch, +41 31 63 2 48 18, Department of Visceral Surgery and Medicine, Berne University Hospital, University of Berne, Berne, Switzerland, (ICTRP)
Secondary trial IDs
2021-02433 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05356962 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available