Clinical Investigation Unit

StOP? II Study

MT1186-A02 (Edaravone)

About the trial

Multicenter, cluster-randomized parallel-group trial to test if performing the StOP?-protocol improves patient outcomes after operations. The StOP?-protocol is a short intraoperative briefing within the team present in the operating room and it is initiated and led by the responsible surgeon. It takes typically between 30 and 90 seconds.

In this multicentric clinical study, individual surgeons from different surgical specialties are randomized either to the control group or to be trained in StOP?-protocol use. The control group represents the local standard of care that may include other interventions such as checklists or team trainings. A total of 400 surgeons will be recruited, and the study expects to collect patient outcome data for 14,000 surgical procedures.

Expected results will reveal if clinical outcomes can be improved by addressing team behavior during the performance of complex procedures. In particular, the study has the potential to provide evidence that a short and inexpensive intraoperative briefing may reduce mortality, morbidity as well as patient-reported outcomes after surgery.

Link to study website

How DCR - CIU supports the trial

The DCR - CIU team retrieves the study data from the various medical reports to record to the electronic case report form / study database.

Guido Beldi, Prof., MD, Universitätsklinik für Viszerale Chirurgie und Medizin

Universitätsspital Inselspital Bern

Funded by Swiss National Science Foundation (SNSF)