The study will be a multicenter randomised controlled trial of the use of irrigation fluid of body temperature versus irrigation fluid of room temperature during burr hole evacuation of chronic subdural hematoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
588
Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.
Sahlgrenska Universtity Hospital, Department of neurosurgery, Sweden
Gothenburg, Sweden
Karolinska University Hospital, Department of neurosurgery, Sweden
Solna, Sweden
Uppsala University Hospital, Department of neurosurgery, Sweden
Uppsala, Sweden
Recurrence rate
Recurrences requiring repeat surgery during a 6-month follow up period
Time frame: 6 months
Mortality
The proportion deceased at a given time during the 6 month follow up.
Time frame: 6 months
Complications related to the surgery
Complications will be assessed using the Landriel Ibanez classification modelThis model grades complications in 4 grades (Grade 1: no invasive treatment required; Grade 2: invasive treatment required, but not intensive care; Grade 3: invasive treatment required and intensive care; Grade 4: death).
Time frame: 6 months
Health related quality of life
A standardised instrument, EuroQoL 5D-3L, will be used as a generic measure of health related quality of life. The questionnaire contains 5 questions in different domains.
Time frame: 6 months
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