StOP? II trial started enrolment
24.10.2022 – The StOP? II trial started recruitment in October 2022.
This is a cluster randomized clinical trial to test the effects of the implementation of a toolbox for structured communication in the operating room vs usual care.
Operations are performed by a multidisciplinary team of surgeons, anesthetists and nurses and remains associated with mortality. The StOP?-protocol introduces a structured intraoperative communication toolbox to improve communication. The primary hypothesis is that the consistent use of the StOP?-protocol by the responsible surgeon reduces patient mortality within 30 days after the operation as compared to usual care. In total, 400 surgeons of various surgical disciplines from Switzerland, Germany and Austria will be randomized 1:1 to the StOP? intervention group or to the standard of care (control) group. The unit of observation will be operations performed by those cluster surgeons. Consecutive patients will be enrolled over four months per randomized surgeon for a total of more than 12,000 operations. CTU Bern is involved in regulatory support, data management, website, statistics, central data and on-site monitoring; and Clinical investigation is providing support for data entry.
Further information can be found on the project website.