Comparing endoscope-assisted versus burr-hole drainage for chronic subdural hematoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized comparison of neuroendoscopy-assisted hematoma evacuation versus conventional burr-hole drainage for chronic subdural hematoma. Patients with symptomatic, imaging-confirmed CSDH who require surgical drainage will be randomized to one of the two procedures and followed for postoperative recurrence, drainage duration, and neurological outcomes. Neuroendoscopy allows direct visualization to irrigate, aspirate, and cut septations, which may reduce residual hematoma compared with blind burr-hole drainage. The trial aims to determine which approach produces lower recurrence rates and faster recovery across several Chinese neurosurgical centers.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Tiantan Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• First Affiliated Hospital of Xiamen University
  Xiamen, Fujian, China Recruiting
• Jiangmen Central Hospital
  Jiangmen, Guangdong, China Recruiting
• Shantou central hosital
  Shantou, Guangdong, China Recruiting
• People's Hospital of Longhua, Shenzhen
  Shenzhen, Guangdong, China Recruiting
• Liuzhou worker's Hospital
  Liuzhou, Guangxi, China Recruiting

Study contacts

• Principal investigator: Guoyi Gao, MD — Beijing Tiantan Hospital
• Study coordinator: Liang Wu, MD
• Email: jasewl@sina.com
• Phone: 18301674233

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.