Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.
Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
CSDH verified on cranial computed tomography or magnetic resonance imaging.
Written informed consent from patients or their next of kin according to the patient's cognitive status.
No clinical symptoms correlating with chronic subdural hematoma.
Lack of mass effect and midline shift < 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.
Previous surgery for CSDH during the past 6 months.
Previous intracranial surgery for any other neurological disorder.
Parallel
Endoscope-assisted hematoma drainage
Procedure/SurgeryThe procedure of endoscope-assisted hematoma drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as shown on CT scan. A bone flap measuring 2.0 cm × 2.0 cm is then created using a milling cutter. Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated. A subdural drainage tube is inserted, and postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.
Burr hole hematoma drainage
Procedure/SurgeryThe procedure of burr hole drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as indicated by CT scan. A subdural drainage tube is then inserted. The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear. Postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.
Recurrence rate within 3 months after operation
To compare the difference in recurrence rate at 3 months postoperatively between the two groups.
Mortality rate within 3 months after operation
To compare the difference in mortality rate at 3 months postoperatively between the two groups.
Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation
Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.
Change of Markwalder Grading Scale (MGS) between groups from baseline to 3 months after operation
Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.
Change of Quality of life assessment (EQ-5D-5L) between groups from baseline to 3 months after operation
A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'postoperatively between the two groups.
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