Neuroendoscopy-assisted Drainage Versus Burr Hole Drainage for Chronic Subdural Hematoma (URANUS)

Capital Medical University

Status: Not yet enrolling

Conditions: Chronic Subdural Hematoma

Treatments: Procedure: Endoscope-assisted hematoma drainage; Procedure: Burr hole hematoma drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT07144423

HX-A-2025027

Details and patient eligibility

About

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.

Full description

Chronic subdural hematoma (CSDH) is a common disease in neurosurgery. It is generally considered to be a closed fluid collection situated between the dura mater and arachnoid mater, formed by blood or blood degradation products. This collection causes a local mass effect, compressing adjacent brain tissue and leading to varying degrees of neurological dysfunction. In severe cases, it can induce brain herniation, endangering the patient's life. In recent years, despite the availability of various pharmacological and surgical treatment options for CSDH, the efficacy and long-term prognosis of these treatment methods and strategies remain not entirely clear, and a standardized treatment approach has yet to be established. Neuroendoscopy-assisted hematoma drainage is one of the treatment methods for CSDH, but its current application is not widespread. The core of this method involves neurosurgeons directly observing the hematoma structure during surgery with the assistance of a neuroendoscope, enabling them to thoroughly irrigate and aspirate the hematoma under direct vision and sever hematoma septations. This approach enhances the hematoma clearance rate, ultimately reducing the amount of postoperative hematoma residue. Compared with conventional burr-hole drainage, neuroendoscopy-assisted burr-hole drainage reduces the recurrence rate of CSDH and shortens the duration of postoperative drainage. This study aims to conduct a multicenter randomized controlled trial comparing neuroendoscopy-assisted hematoma drainage with burr-hole drainage, with the objective of scientifically and rigorously determining the optimal clinical treatment strategy for CSDH.

Enrollment: 770 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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770 participants in 2 patient groups

Neuroendoscope-assisted hematoma drainage

Experimental group

Description:

Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated.

Treatment:

Procedure: Endoscope-assisted hematoma drainage

Burr hole hematoma drainage

Other group

Description:

The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear.

Treatment:

Procedure: Burr hole hematoma drainage