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.
Chronic subdural hematoma (CSDH) is a common disease in neurosurgery. It is generally considered to be a closed fluid collection situated between the dura mater and arachnoid mater, formed by blood or blood degradation products. This collection causes a local mass effect, compressing adjacent brain tissue and leading to varying degrees of neurological dysfunction. In severe cases, it can induce brain herniation, endangering the patient's life. In recent years, despite the availability of various pharmacological and surgical treatment options for CSDH, the efficacy and long-term prognosis of these treatment methods and strategies remain not entirely clear, and a standardized treatment approach has yet to be established. Neuroendoscopy-assisted hematoma drainage is one of the treatment methods for CSDH, but its current application is not widespread. The core of this method involves neurosurgeons directly observing the hematoma structure during surgery with the assistance of a neuroendoscope, enabling them to thoroughly irrigate and aspirate the hematoma under direct vision and sever hematoma septations. This approach enhances the hematoma clearance rate, ultimately reducing the amount of postoperative hematoma residue. Compared with conventional burr-hole drainage, neuroendoscopy-assisted burr-hole drainage reduces the recurrence rate of CSDH and shortens the duration of postoperative drainage. This study aims to conduct a multicenter randomized controlled trial comparing neuroendoscopy-assisted hematoma drainage with burr-hole drainage, with the objective of scientifically and rigorously determining the optimal clinical treatment strategy for CSDH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
770
The 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.
The 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.
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFirst Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGJiangmen Central Hospital
Jiangmen, Guangdong, China
RECRUITINGShantou central hosital
Shantou, Guangdong, China
RECRUITINGPeople's Hospital of Longhua, Shenzhen
Shenzhen, Guangdong, China
RECRUITINGLiuzhou worker's Hospital
Liuchow, Guangxi, China
RECRUITINGThe Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITINGNanning First People's Hospital
Nanning, Guangxi, China
RECRUITINGThe First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine
Nanning, Guangxi, China
RECRUITINGWuzhou Gongren Hospital
Wuzhou, Guangxi, China
RECRUITING...and 14 more locations
Recurrence rate within 3 months after operation
To compare the difference in recurrence rate at 3 months postoperatively between the two groups.
Time frame: From operation up to 3 months postoperatively
Mortality rate within 3 months after operation
To compare the difference in mortality rate at 3 months postoperatively between the two groups.
Time frame: From operation up to 3 months postoperatively
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.
Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation
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.
Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation
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.
Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation
Rate of complications and adverse events between groups within 3 months
Rate of complications and adverse events between the two groups within 3 months.
Time frame: From operation up to 3 months postoperatively
Postoperative drainage time
To compare the difference in length of postoperative drainage between the two groups.
Time frame: immediately after the procedure
Length of hospitalization
To compare the difference in length of hospitalization between the two groups.
Time frame: immediately after the procedure
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