Cerebral Aneurysm Clinical Trial
Official title:
Safety Study of Minimally Invasive Approaches to Unruptured Anterior Circulation Aneurysms
The study is designed to evaluate the efficacy and safety of minimally invasive neurosurgical techniques for patients with incidental cerebral aneurysms of the anterior circulation in the Hospital das Clínicas of the University of São Paulo Medical School.
Minimally Invasive Neurosurgery is a inexorable tendency and it is already a reality in many
centers of the world. It is a broad and relative concept and there is few consistent medical
data to validate its benefits. In this manner, this is the first clinical trial in Brazil
questioning the safety of the of minimally invasive surgery to treat incidental cerebral
aneurysms of the anterior circulation. For countries like Brazil, the indirect demonstration
of reduction in hospital costs through lower hospital stays is a breakthrough to provide
better health for the entire population.
Patients with the diagnosis of incidental brain aneurysms of the anterior circulation will
be recruited from the spontaneous demand of the Hospital das Clínicas of University of São
Paulo Medical School. The investigators expect to recruit 60 patients for the experimental
group and 60 for the control group.
In the study group patients will be submitted to a minimally invasive approach
(transpalpebral mini fronto-orbital craniotomy or modified minipterional craniotomy). All
patients in this group will be submitted to surgery starting at 8 o'clock in the morning.
After 6 hours of the end of surgery, all patients will have a control CT scan and if the
result is adequate, they are going to be discharged from the ICU with no IV drugs. The
hospital discharge will be in the next day. The control group are patients that will be
submitted to a classical pterional craniotomy with hospital discharge occurring in 4-5 days.
All patients will be submitted to the standard care offered by the Hospital das Clinicas.
All surgical and ambulatory data will be collected by the main investigators (Dr. Mauricio
Mandel and Dr. Eberval Figueiredo). The adverse events will be promptly reported to the
chair of the department and to the CAPPESQ (the ethics committee of the hospital).
Ambulatory data will be collected during the regular post operative medical appointments and
a web based questionnaire. The post operative follow-up is unified in only one ambulatory
center and day (thursdays mornings).
Statistical analysis will compare primary and secondary objectives of the two groups, as
specified in the study protocol.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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