Status:
UNKNOWN
Cranioplasty Cognitive Outcome Study
Lead Sponsor:
Kwong Wah Hospital
Collaborating Sponsors:
The Queen Elizabeth Hospital
Queen Mary Hospital, Hong Kong
Conditions:
Cognitive Impairment
Brain Herniation
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief 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 ...
Detailed Description
Decompressive craniectomy, a neurosurgical procedure where a portion of the skull calvarium is removed, is a life-saving procedure. The complication rate of cranioplasty, a neurosurgical procedure whe...
Eligibility Criteria
Inclusion
- 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
- 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
- Any pre-existing illness that renders the patient moderately or severely disabled before the brain insult.
- Patients that need an additional procedure e.g. cerebrospinal fluid shunting with cranioplasty in the same setting.
- History of central nervous system infection
- Craniectomy-related complications such as hemorrhage or surgical site infection requiring surgical intervention or deemed to affect patient's long-term cognitive outcome
- Claustrophobia or any other medical condition that prohibits the patient from undergo MRI scanning
- Patients who cannot understand spoken English or Chinese
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03791996
Start Date
March 1 2019
End Date
March 1 2021
Last Update
October 17 2019
Active Locations (1)
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1
Kwong Wah Hospital
Hong Kong, Hong Kong, China