Impact of Cranioplasty on Cognitive Outcome: A Multi-Center Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MOCA)
研究概览
简要总结
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.
详细描述
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 where the acquired skull defect is reconstructed, ranges from 11% to 26% and includes postoperative hemorrhage and infection. (4) The syndrome of the trephined is a recognized long-term complication in which certain groups of patients, experience debilitating neurocognitive deficits in addition to chronic headache, dizziness, fatigability and clinical depression. (2) It is believed that the lack of an overlying bone may cause undue significant atmospheric pressure on the underlying cortex, thereby reducing cerebral perfusion and cerebrospinal fluid flow. There are reports that cognitive improvement can be observed in up to 30% of patients after cranioplasty yet the underlying mechanism for this observation is unclear. (1) Some studies have demonstrated enhanced cerebral perfusion by non-invasive investigations, but there is a lack of large scale systematically performed studies to verify such cerebral hemodynamic effects. (1-3) Clinical equipoise exists regarding the optimum timing of cranioplasty procedures after craniectomies. While the anecdotal practice of delaying cranioplasty for at least 3 months after a craniectomy is common, local and overseas observational studies suggest that performing early cranioplasties (i.e. within 3 months) is equally safe in terms of infection and other operative complications. (4-6)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
1:1 block central randomisation with assignments written on a card sealed in an opaque envelop.
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
"Late" cranioplasty
Subjects undergoing cranioplasty within 3 months after craniectomy.
"Early" cranioplasty
Subjects undergoing cranioplasty beyond 3 months after craniectomy.
干预措施: "Early" cranioplasty (Procedure)
结局指标
主要结局
Montreal Cognitive Assessment (MOCA)
时间窗: 3-months
Minimum (worse): 0/30; Maximum (best) 30/30. Higher values represent a better outcome.
Rivermead Behavioural Memory Test (RBMT)
时间窗: 3-months
Neurobehavioural Cognitive State Examination (NCSE)
时间窗: 3-months
Multi-domain assessment involving: orientation, attention, registration, comprehension, repetition, naming, construction, calculation, similarities,judgement. Stratification of each domain into mild, moderate and severe impairment. The higher the number the better the outcome.
次要结局
- Quality of life assessment(3-months)
- Psychological assessment(3-months)
- Motor assessment(3-months)
- Caregiver assessment(3-months)
- Modified Functional Ambulation Category (MFAC)(3-months)
- Caregiver(3-months)
- MRI cerebral perfusion assessment(3-months)
研究者
Peter Woo Yat Ming
Principal Investigator
Kwong Wah Hospital