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

Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma: A Multicenter Randomized Controlled Trial, URANUS

This trial will test whether endoscope-assisted drainage works better than standard burr-hole drainage for adults (18–90) with symptomatic, imaging-confirmed chronic subdural hematoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 770 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 24 sites (Beijing, Beijing Municipality and 23 other locations)
• Trial ID: NCT07144423 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18 to 90 with symptomatic, CT- or MRI-confirmed chronic subdural hematoma who are judged to need surgical drainage and can provide informed consent are ideal candidates.

Not a fit: Patients without clinical symptoms or mass effect (midline shift < 5 mm), those who cannot tolerate surgery because of severe comorbidities or coagulopathy, or those with recent intracranial surgery are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the endoscope-assisted approach could lower recurrence rates, shorten drainage time, and improve neurological recovery after CSDH surgery.

How similar studies have performed: Smaller observational and single-center reports have suggested neuroendoscopy can reduce recurrence and drainage duration, but large multicenter randomized evidence is limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 23 other locations

• 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)
• The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
• Nanning First People's Hospital — Nanning, Guangxi, China (Recruiting)
• The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine — Nanning, Guangxi, China (Recruiting)
• Wuzhou Gongren Hospital — Wuzhou, Guangxi, China (Recruiting)
• Hebei University of Engineering Affiliated Hospital — Handan, Hebei, China (Recruiting)
• Xingtai Central Hospital — Xingtai, Hebei, China (Recruiting)
• Changde First People's Hospital — Changde, Hunan, China (Recruiting)
• People's Hospital of Xiangxi Prefecture, Hunan Province — Jishou, Hunan, China (Recruiting)
• Yueyang Central Hospital — Yueyang, Hunan, China (Recruiting)
• Heji Hospital affiliated with Changzhi Medical College — Changzhi, Shanxi, China (Recruiting)
• Linfen People's Hospital — Linfen, Shanxi, China (Recruiting)
• Shanxi Provincial People's Hospital,Shanxi Medical University — Taiyuan, Shanxi, China (Recruiting)
• The Second Affiliated Hospital of Xi'an Medical University — Xi’an, Shanxi, China (Recruiting)
• Mianyang 404 Hospital — Mianyang, Sichuan, China (Recruiting)
• the First People'S Hospital of Yibin — Yibin, Sichuan, China (Recruiting)
• First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (Recruiting)
• Pu'er People's Hospital — Pu'er, Yunnan, China (Recruiting)
• First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Guoyi Gao, MD — Beijing Tiantan Hospital
• Study coordinator: Liang Wu, MD

Conditions Chronic Subdural Hematoma; Neuroendoscopy-assisted Drainage; Burr Hole Drainage; Recurrence Rate; Neurological Outcome