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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| surgical plus medical treatment | Active Comparator | Decompressive surgery protocol was kept constant throughout the study period and defined the following surgical interventions: (1) extensive bilateral suboccipital decompresive craniectomy with duraplasty, optional resection of the posterior arch of atlas, (2) preceding insertion of an external ventricular drainage (EVD) in all cases, and (3) evacuation of necrotic tissue. |
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| conservative medical treatment | No Intervention | Control group (conservative medical) was treated equally aggressive with regard to intensive care measures. Medical management generally followed the Turkish and European guidelines on acute stroke care valid at the time of patient admission. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suboccipital decompressive craniectomy | Procedure | extensive bilateral suboccipital decompressive craniectomy with duraplasty |
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| Measure | Description | Time Frame |
|---|---|---|
| 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]). | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Death | Patient who died due to surgery | 1 year |
| Barthel Index, | Barthel index which ranges from 0 [dependent] to 100 [Totally independent)](streamdown:incomplete-link) |
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Inclusion Criteria:
Exclusion Criteria:
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Plan to Share IPD is 'Yes"
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Participants assigned to either conservative medical or SDC group with a 1:1 allocation assignment using a random number table by co-decision of a neurologist, neurosurgeon and statistician
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a senior neurologist (E.K. or M.D.) who was not involved in screening, randomization, or patient care, blinded to the therapeutic arm assignment of the patient assessed the mRS (primary outcome), Barthel Index, NIHSS (National Institute of Health Stroke Scale), and SF-36 (secondary outcomes) scores
| 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) | 1 year |