Cranioplasty Cognitive Outcome Study (NCT03791996) | Clinical Trial Compass
UnknownNot Applicable
Cranioplasty Cognitive Outcome Study
China30 participantsStarted 2019-03-01
Plain-language summary
This will be a multicenter prospective randomized study of adult patients with an acquired skull defect as a result of craniectomy and considered suitable for cranioplasty, i.e. reconstruction of the skull defect, at all seven Hong Kong Hospital Authority neurosurgical units. Patients that underwent their primary craniectomy operation at any of the Hospital Authority neurosurgery centers from the 1st March 2019 and considered suitable for cranioplasty will be included in this study. Those who underwent their primary craniectomy before 1st March 2019 or at an institution other than the aforementioned neurosurgical units will be excluded. Data from clinical records, operation notes, medication-dispensing records, laboratory records and radiological reports will be collected.
30 adult patients with craniectomy will be recruited and randomized into two groups: "early" cranioplasty, i.e. performed within 3 months of craniectomy, and "late", i.e. cranioplasty performed more than 3 months after the operation. The aim of the study is to determine whether early cranioplasty can improve on patient's cognitive performance compared to those who undergo the procedure after 3 months.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. Age greater than or equal to 18 years-old,
✓. Craniectomy was performed due to head injury, infarct or spontaneous intracerebral hemorrhage, and benign tumors.
✓. Craniectomy skull defect size of \>10cm at its longest diameter
✓. Craniectomy performed at any of the Hospital Authority's Neurosurgical Centers after 1st March 2019
Exclusion criteria
✕. Age older than 80 years-old,
✕. Patients cannot communicate by obeying simple command,
✕. Patients who are unfit for cranioplasty as decided by the treating neurosurgeon
✕. Posterior fossa craniectomy
✕. Craniectomy performed before 1st March 2019
✕. Craniectomy performed at an institution outside the Hospital Authority
What they're measuring
1
Montreal Cognitive Assessment (MOCA)
Timeframe: 3-months
2
Neurobehavioural Cognitive State Examination (NCSE)