Frontal Versus Parietal Eminence Twist-Drill Drainage for Chronic Subdural Hematoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 440
- 试验地点
- 3
- 主要终点
- Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •Concomitant intracranial conditions requiring specific treatment, including but not limited to: intracranial tumor, brain abscess, vascular malformation, or ruptured aneurysm.
- •Severe coagulation disorder that cannot be corrected before surgery.
- •Life expectancy < 6 months.
- •Any condition that, in the judgment of the investigator, makes the patient inappropriate for participation in the study.
结局指标
主要结局
Ipsilateral cSDH recurrence requiring reoperation within 3 months after surgery
时间窗: 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.
次要结局
- Residual hematoma maximum thickness("Day 2", "Month 1", "Month3" after operation)
- Residual hematoma volume("Day 2", "Month 1", "Month3" after operation)
- Intra-cranial pneumocephalus volume("Day 2", "Month 1" after operation)
- Improvement in midline shift("Day 2", "Month 1", "Month3" after operation)
- Drain duration / catheter indwelling time(immediately after the procedure)
- Postoperative complications(From operation up to 3 months postoperatively)
- Markwalder grade at 7days, 30 days and 3 months("Day 7", "Month 1", "Month3" after operation)
- Modified Rankin Scale (mRS) at 7days, 1 months, and 3 months("Day 7", "Month 1", "Month3" after operation)
- Mortality rate within 3 months after operation(From operation up to 3 months postoperatively)
研究者
Jie Shen
Principal Investigator
The Second Hospital of Anhui Medical University