Chronic Subdural Hematoma
Conditions
Keywords
chronic subdural hematoma, twist drill, parietal eminence puncture, frontal puncture
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREFrontal-region puncture drainage
Patients will undergo burr-hole puncture drainage at the frontal region (frontal puncture) for chronic subdural hematoma (cSDH).
PROCEDUREParietal Eminence region puncture drainage
Patients will undergo burr-hole puncture drainage at the Parietal Eminence/tubercle region (vertex puncture) for cSDH.
Sponsors
The Second Hospital of Anhui Medical University
Yangzhou University
Huai'an First People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized, controlled, parallel-group clinical trial; participants assigned 1:1 to two intervention arms (frontal vs parietal eminence puncture site) using minimally invasive burr-hole drainage with closed-system drainage; outcome assessors blinded where feasible.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years. 2. Unilateral chronic subdural hematoma (cSDH) or subacute-to-chronic subdural hematoma, confirmed by CT or MRI. 3. Presence of clinical symptoms attributable to cSDH, such as headache, limb weakness, gait disturbance, cognitive decline, speech disturbance, seizure, or impaired consciousness. 4. 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. 5. Plan to undergo twist-drill puncture drainage with a closed drainage system. 6. Written informed consent signed by the participant or their legally authorized representative.
Exclusion criteria
1. Bilateral cSDH requiring simultaneous bilateral surgery. 2. Acute subdural hematoma, or a condition where the hematoma is predominantly composed of an acute hemorrhagic component. 3. Markedly septated, organized, or calcified hematoma in which minicraniotomy or craniotomy is required preoperatively. 4. Previous surgery on the ipsilateral side for cSDH. 5. Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm. 6. Severe coagulation disorder that cannot be corrected before surgery. 7. Life expectancy \< 6 months. 8. Pregnancy. 9. Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery | 3 months | Recurrence defined as ipsilateral hematoma re-enlargement or symptom recurrence, confirmed by imaging, and judged by the treatment team to require repeat surgical intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Residual hematoma maximum thickness | "Day 2", "Month 1", "Month3" after operation | Measured on postoperative CT as the maximum thickness of the residual ipsilateral cSDH. |
| Residual hematoma volume | "Day 2", "Month 1", "Month3" after operation | Measured on postoperative CT as the hematoma volume of the residual ipsilateral cSDH. |
| Intra-cranial pneumocephalus volume | "Day 2", "Month 1" after operation | Measured on postoperative CT as the volume of intracranial pneumocephalus (air within the cranial cavity). |
| Improvement in midline shift | "Day 2", "Month 1", "Month3" after operation | Assessed on follow-up imaging by comparing the midline shift against baseline/protocol-defined preoperative value; reported as the degree of improvement. |
| Drain duration / catheter indwelling time | immediately after the procedure | Time from catheter placement to catheter removal, reported as hours/days per protocol. |
| Postoperative complications | From operation up to 3 months postoperatively | Any adverse events occurring postoperatively, including (but not limited to): acute subdural hematoma, intracerebral hemorrhage, seizure, infection, tension pneumocephalus, and drain/catheter misplacement. |
| Markwalder grade at 7days, 30 days and 3 months | "Day 7", "Month 1", "Month3" after operation | Neurological symptom severity scored using the Markwalder scale at the specified follow-up time points. |
| Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months | "Day 7", "Month 1", "Month3" after operation | Functional status measured by mRS at the specified follow-up time points. |
| Mortality rate within 3 months after operation | From operation up to 3 months postoperatively | Death from any cause assessed at 3 months after surgery. |
Countries
China
Contacts
CONTACTjie shen, MD
STUDY_DIRECTORqi li, MD
The Second Hospital of Anhui Medical University
Outcome results
None listed