This clinical trial aims to find out whether the puncture site used during minimally invasive surgery with twist-drill puncture and closed-system drainage affects the treatment of chronic subdural hematoma (cSDH).
The target population is adults with a unilateral chronic subdural hematoma who need surgical drainage based on their symptoms and imaging findings (CT/MRI).
The main questions this study is designed to answer are:
There are two groups, researchers will compare:
Participants will:
Inclusion Criteria:
Age ≥ 18 years.
Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI.
Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness.
Radiological indication for surgery, defined as one of the following:
Maximum hematoma thickness ≥ 10 mm, and/or Midline shift ≥ 5 mm, or Even if these thresholds are not met, clinically significant symptoms requiring surgery as judged by the treating neurosurgeon.
Plan to undergo twist-drill puncture drainage with a closed drainage system.
Written informed consent signed by the participant or their legally authorized representative.
Exclusion Criteria:
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Surgeons and operating room staff cannot be masked because of the nature of the surgical intervention. Radiological outcome assessors, clinical outcome assessors when feasible, members of the endpoint adjudication committee, and statistical analysts will be masked to treatment allocation until the primary analysis is completed.
The puncture point is selected within the anterior coverage region of the hematoma area-typically within the frontal bone region anterior to the coronal suture-avoiding the frontal sinus, obvious cortical veins, and key functional areas. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment.
The puncture point is selected at the vertex (crown vertex) region within the hematoma area. The exact location is determined based on preoperative CT 3D reconstruction, with principles of safe entry into the subdural hematoma space and an appropriate catheter direction toward the main hematoma cavity/compartment.
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