Chronic subdural hematoma is a collection of blood and fluid on the surface of the brain that is common in older adults. Burr-hole drainage is a standard surgical treatment, but the hematoma may come back in some patients and require another procedure.This study will test whether using a patient-specific 3D-printed template to guide burr-hole placement, combined with coagulation of the middle meningeal artery during surgery, can reduce the risk of hematoma recurrence compared with standard burr-hole drainage.Participants with symptomatic chronic subdural hematoma who need surgery will be randomly assigned to one of two groups. One group will receive standard burr-hole drainage. The other group will receive 3D-printed template-guided burr-hole drainage with attempted intraoperative frontal branch of the middle meningeal artery coagulation when it can be safely performed.The main outcome is whether the hematoma comes back and requires another invasive treatment within 3 months after surgery. The study will also assess brain imaging results, neurological recovery, complications, hospital stay, and the feasibility and safety of the 3D-printed template and artery coagulation procedure.
Patients diagnosed with chronic subdural hematoma based on clinical symptoms and cranial CT or MRI.
Patients scheduled to undergo burr-hole drainage surgery.
Age 18 years or older.
Written informed consent obtained from the patient or legal representative.
Acute subdural hematoma or other intracranial lesions requiring different surgical management.
Previous surgery for the same episode of chronic subdural hematoma.
Severe coagulation disorder or other contraindications to surgery.
Severe systemic disease making the patient unsuitable for participation.
Parallel
Standard Burr-Hole Drainage Group
Procedure/SurgeryStandard burr-hole drainage performed according to routine clinical practice for chronic subdural hematoma.
3D-Printed Template-Guided Burr-Hole Drainage With Attempted MMA Coagulation Group
Procedure/SurgeryBurr-hole drainage performed using a patient-specific 3D-printed template for surgical guidance, combined with attempted intraoperative coagulation of the middle meningeal artery.
Recurrence of Chronic Subdural Hematoma Requiring Invasive Re-intervention within 3 Months after Surgery
Recurrence is defined as radiologically confirmed recurrent chronic subdural hematoma requiring repeat surgical intervention within 3 months after the initial surgery (e.g., repeat burr-hole drainage, craniotomy, endoscopic treatment, and/or MMA embolization).
Incidence of cSDH Recurrence (Hematoma Progression)
Incidence of cSDH Recurrence (Hematoma Progression): Hematoma progression will be defined as radiological increase in ipsilateral and/or bilateral subdural hematoma on follow-up imaging compared with the predefined postoperative baseline. Hematoma progression (Yes/No) will be considered present if any of the following criteria are met: (1) increase in maximal subdural hematoma thickness by ≥ 5 mm; (2) increase in midline shift by ≥ 3 mm; or (3) increase in hematoma cavity volume by ≥ 25%. The incidence will be reported as a percentage.
Functional Outcome Measured by the Modified Rankin Scale (mRS)
Functional Outcome Measured by the Modified Rankin Scale (mRS): Functional status will be measured using the Modified Rankin Scale (mRS), a 7-point ordinal scale ranging from 0 (no symptoms) to 6 (death). Lower scores indicate better functional outcome.
MMA identification rate
Deviation between Planned and Actual Burr-hole Sites: MMA identification rate will be reported as a percentage.
Number of participants experiencing one or more peri-operative surgical or medical complications
Incidence of Peri-Operative Complications：Number of participants experiencing one or more peri-operative surgical or medical complications (e.g., wound infection, seizure, pneumonia, venous thromboembolism, acute subdural haematoma). Reported as a count and percentage.
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The Second Hospital of Anhui Medical University
Lead sponsor
Xijing Hospital
Collaborator
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