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:
* Does the puncture site affect the risk of same-side cSDH recurrence requiring reoperation within 3 months * Does the puncture site affect recovery and key clinical outcomes after surgery (including functional status and postoperative recovery measures)
There are two groups, researchers will compare:
* Group A: patients receiving puncture at the frontal region vs. * Group B: patients receiving puncture near the parietal eminence to determine whether one puncture site leads to better outcomes than the other.
Participants will:
* undergo a surgical procedure where, based on random assignment, the puncture site is either frontal or near the parietal eminence; * receive closed-system drainage after a twist-drill puncture; * complete follow-up assessments at discharge, 30 days, 3 months after surgery, which will include symptom review and imaging (CT) evaluations to check hematoma changes and recurrence; * have safety monitoring throughout the study period to record any complications or adverse events.
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.
Plan to undergo twist-drill puncture drainage with a closed drainage system.
Bilateral cSDH requiring simultaneous bilateral surgery.
Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component.
Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively.
Previous surgery on the ipsilateral side for cSDH.
Parallel
Frontal-region puncture drainage
Procedure/SurgeryPatients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Parietal Eminence region puncture drainage
Procedure/SurgeryPatients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention.
Residual hematoma maximum thickness
Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.
Residual hematoma volume
Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.
Intra-cranial pneumocephalus volume
Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity).
Improvement in midline shift
Assessed on follow-up imaging by comparing the midline shift against baseline/protocol-defined preoperative value; reported as the degree of improvement.
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The Second Hospital of Anhui Medical University
Lead sponsor
Yangzhou University
Collaborator
Huai'an First People's Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
