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Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma

RecruitingNAAges 18 Years - 90 YearsAllBeijing Tiantan Hospital
NCT07144423 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Chronic subdural hematoma (CSDH) is a frequent condition in neurosurgery, leading to fluid accumulation between the meninges, brain compression, neurological dysfunction, and potentially herniation. The efficacy of treatments and their long-term outcomes remain uncertain, with no established standard. Notably, neuroendoscopy-assisted hematoma evacuation, in contrast to burr-hole drainage, enables direct visualization and thorough removal of the hematoma, thereby minimizing residue, lowering recurrence rates, and shortening drainage duration. This study will undertake a multicenter trial to compare these two methods and determine the superior treatment approach for CSDH.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH. 2. CSDH verified on cranial computed tomography or magnetic resonance imaging. 3. Written informed consent from patients or their next of kin according to the patient's cognitive status. Exclusion Criteria: 1. No clinical symptoms correlating with chronic subdural hematoma. 2. Lack of mass effect and midline shift \< 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons. 3. Previous surgery for CSDH during the past 6 months. 4. Previous intracranial surgery for any other neurological disorder. 5. Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed. 6. Severe coagulopathy or a high risk of life-threatening bleeding (including any one of the following three criteria: prothrombin time or activated partial thromboplastin time prolonged by more than 10 seconds; international normalized ratio \> 3.0; absolute platelet count \< 100×109/L). 7. Postoperative compliance is suspected to be insufficient for 3-month follow-up visit. 8. Reproductive-age women without verified negative pregnancy testing. 9. Participating in another research.
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What it tests

  • Endoscope-assisted hematoma drainage
  • Burr hole hematoma drainage
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Where

24 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
First Affiliated Hospital of Xiamen University
Xiamen, China
Jiangmen Central Hospital
Jiangmen, China
Shantou central hosital
Shantou, China
People's Hospital of Longhua, Shenzhen
Shenzhen, China
Liuzhou worker's Hospital
Liuzhou, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, China
Nanning First People's Hospital
Nanning, China

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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