An interventional study of suboccipital decompressive craniectomy in Cerebellar Stroke, sponsored by Ege University. Completed. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-01-04.
Sponsored by Ege University · Not applicable, Interventional, and Prevention
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.
2,561 studies on the registry are indexed under Infarction; 251 are open to participants now.
This study's enrollment of 72 is below the median of 129 across 1,501 interventional studies indexed under Infarction.
Browse Infarction studies →Ege University is the lead sponsor of 365 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Procedure: suboccipital decompressive craniectomy
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.
extensive bilateral suboccipital decompressive craniectomy with duraplasty
Also known as: space occupying surgey
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
No study locations are listed for this record.
Plan to share: Undecided — Plan to Share IPD is 'Yes"
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Ege University