Serious Adverse Events (SAEs) have to be reported by the local physicians to the Clinical Trial Center (CTC), within 24 hours. The studycoordinator will thereafter report the event to the ethics committee via ToetsingOnline. More elaborate information on SAE notitification you can find here.
In this trial an SAE is any undesired event/effect that is related to the trial intervention..:
- resulting in the death of a patient
- that is lifethreatening (e.g. intensive care admission because of sepsis due to an intraabdominal infection)
- that prolonges hospital admission (e.g. readmission due to surgical site infection)
- resulting in persistent or significant disability
- any other sort of event that could have led to one of the above, were it not for medical or surgical intervention (e.g. opening the wound (infection) on the ward)
Events/complications that are unrelated to the trial intervention (e.g. ileus, or a urinary tract infection in the postopererative course) are not considered an SAE in this study. If there is even the slightest suspicion of causality, the event should be reported as an SAE. Elective admissions are not considered an SAE.