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.
This is a (multi-center) prospective, randomized, parallel-group, assessor-blinded clinical trial in eligible patients with unilateral chronic subdural hematoma (cSDH) to compare the effects of puncture-site location on outcomes after minimally invasive drainage: participants will be randomly assigned 1:1 to Group A (frontal twist-drill puncture drainage) or Group B (parietal eminence twist-drill puncture drainage), with both groups receiving standardized closed-system subdural drainage and postoperative management; random allocation will be concealed using a secure electronic randomization system or sealed opaque envelopes prepared by a researcher not involved in surgery or outcome assessment. The primary outcome is the rate of ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery (recurrence defined as symptomatic re-accumulation or enlargement confirmed by imaging and judged by the treating team to require repeat intervention). Secondary outcomes include postoperative residual hematoma maximum thickness and volume at 24-48 hours, pneumocephalus volume at 24-48 hours, reduction in midline shift, brain re-expansion rate, drainage duration, length of hospital stay, postoperative complications, Markwalder grading and modified Rankin Scale (mRS) scores at 30 days/3 months, and mortality at 30 days and 3 months; although surgeon blinding is not feasible, radiological and clinical outcome assessors and statisticians will be blinded whenever possible, with anonymized postoperative CT images assessed independently by trained reviewers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
440
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Yangzhou University Affiliated Hospital
Yangzhou, Jiangsu, China
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.
Time frame: 3 months
Residual hematoma maximum thickness
Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH.
Time frame: "Day 2", "Month 1", "Month3" after operation
Residual hematoma volume
Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH.
Time frame: "Day 2", "Month 1", "Month3" after operation
Intra-cranial pneumocephalus volume
Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity).
Time frame: "Day 2", "Month 1" after operation
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.
Time frame: "Day 2", "Month 1", "Month3" after operation
Drain duration / catheter indwelling time
Time from catheter placement to catheter removal, reported as hours/days per protocol.
Time frame: immediately after the procedure
Postoperative complications
Any adverse events occurring postoperatively, including (but not limited to): acute subdural hematoma, intracerebral hemorrhage, seizure, infection, tension pneumocephalus, and drain/catheter misplacement.
Time frame: From operation up to 3 months postoperatively
Markwalder grade at 7days, 30 days and 3 months
Neurological symptom severity scored using the Markwalder scale at the specified follow-up time points.
Time frame: "Day 7", "Month 1", "Month3" after operation
Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months
Functional status measured by mRS at the specified follow-up time points.
Time frame: "Day 7", "Month 1", "Month3" after operation
Mortality rate within 3 months after operation
Death from any cause assessed at 3 months after surgery.
Time frame: From operation up to 3 months postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.