Chronic Subdural Hematoma
Conditions
Keywords
Chronic Subdural Hematoma, Neuroendoscopy-assisted Drainage, Burr Hole Drainage, Recurrence Rate, Neurological Outcome
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREEndoscope-assisted hematoma drainage
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.
PROCEDUREBurr hole hematoma 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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The design is open labeled with only the investigators for postoperative follow-up evaluation, the outcome assessors, and data analysts being blinded in all 24 centers. Before outcome assessment begins at every follow-up evaluation, the patients will be reminded not to reveal any information about their group allocation. If details of group allocation can be detected by the investigator during follow-ups, another blinded researcher will replace to evaluate outcome.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH. 2. CSDH verified on cranial computed tomography or magnetic resonance imaging. 3. Written informed consent from patients or their next of kin according to the patient's cognitive status.
Exclusion criteria
1. No clinical symptoms correlating with chronic subdural hematoma. 2. Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons. 3. Previous surgery for CSDH during the past 6 months. 4. Previous intracranial surgery for any other neurological disorder. 5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed. 6. Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \> 3.0; absolute platelet count \< 100×109/L). 7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit. 8. Reproductive-age women without verified negative pregnancy testing. 9. Participating in another research.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate within 3 months after operation | From operation up to 3 months postoperatively | To compare the difference in recurrence rate at 3 months postoperatively between the two groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality rate within 3 months after operation | From operation up to 3 months postoperatively | 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 | "Day 0", "Day 2", "Month 1", "Month3" 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 | "Day 0", "Day 2", "Month 1", "Month3" 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 | "Day 0", "Day 2", "Month 1", "Month3" 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. |
| Rate of complications and adverse events between groups within 3 months | From operation up to 3 months postoperatively | Rate of complications and adverse events between the two groups within 3 months. |
| Postoperative drainage time | immediately after the procedure | To compare the difference in length of postoperative drainage between the two groups. |
| Length of hospitalization | immediately after the procedure | To compare the difference in length of hospitalization between the two groups. |
Countries
China
Contacts
CONTACTLiang Wu, MD
CONTACTYu Yan, MB
PRINCIPAL_INVESTIGATORGuoyi Gao, MD
Beijing Tiantan Hospital
STUDY_DIRECTORLiang Wu, MD
Beijing Tiantan Hospital
Outcome results
None listed