The investigators aimed to evaluate the outcome in participants up to 80 years of age with space-occupying cerebellar infarction treated with suboccipital decompressive craniectomy (SDC) compared to medical therapy alone.
This trial is a prospective, randomized, controlled, clinical trial based on a stroke center. The primary end point was survival with favorable outcome, defined as a score of 0 to 3 on the mRS at 12 months (±30 days) after randomization (defined by a score of 0 to 3 on the modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]). Secondary outcomes included death, Barthel Index, baseline stroke severity NIHSS (National Institute of Health Stroke Scale), and SF-36 at 6 months and 1-year after randomization. The variables for subgroup analysis were age, sex, time to randomization, lesion volume, brainstem involvement, hemorrhagic transformation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
72
extensive bilateral suboccipital decompressive craniectomy with duraplasty
The primary end point was survival with favorable outcome, defined as a score of 0 to 3 modified Rankin score
The modified Rankin scale (mRS), which ranges from 0 \[no symptoms\] to 6 \[death\]).
Time frame: one year
Death
Patient who died due to surgery
Time frame: 1 year
Barthel Index,
Barthel index which ranges from 0 \[dependent\] to 100 \[Totally independent)
Time frame: 1 year
NIHSS (National Institute of Health Stroke Scale)
independent), NIHSS ranges from 0 to 42 (the higher the score, the more severe the stroke)
Time frame: 1 year
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