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NCT Number: NCT07144423

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

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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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing Municipality, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient (18 years to 90 years) presenting with clinical symptoms and neurological deficits of CSDH.
  • CSDH verified on cranial computed tomography or magnetic resonance imaging.
  • Written informed consent from patients or their next of kin according to the patient's cognitive status.

Exclusion criteria

  • No clinical symptoms correlating with chronic subdural hematoma.
  • Lack of mass effect and midline shift < 5 mm on the radiological image, or no need surgery judged clinically by neurosurgeons.
  • Previous surgery for CSDH during the past 6 months.
  • Previous intracranial surgery for any other neurological disorder.
  • Poor medication conditions or the presence of severe comorbidities so that surgery cannot be tolerated, or follow-up cannot be completed.
  • 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).
  • Postoperative compliance is suspected to be insufficient for 3-month follow-up visit.
  • Reproductive-age women without verified negative pregnancy testing.
  • Participating in another research.

Treatment and study plan

Endoscope-assisted hematoma drainage

Procedure

The procedure of endoscope-assisted hematoma drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as shown on CT scan. A bone flap measuring 2.0 cm × 2.0 cm is then created using a milling cutter. Under the guidance of a visualized neuroendoscope, the hematoma is thoroughly irrigated and evacuated. A subdural drainage tube is inserted, and postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

Burr hole hematoma drainage

Procedure

The procedure of burr hole drainage is performed under local anesthesia with sedation or general anesthesia. During the operation, a single burr hole is drilled at the midpoint of the thickest layer of the hematoma cavity as indicated by CT scan. A subdural drainage tube is then inserted. The hematoma cavity is irrigated intraoperatively until the drainage fluid becomes clear. Postoperatively, continuous subdural drainage of the hematoma is maintained until the drainage ceases naturally or the drainage tube is removed at a maximum of 48 hours postoperatively to terminate the drainage.

Primary outcomes

  1. Recurrence rate within 3 months after operation

    Time frame: From operation up to 3 months postoperatively

    To compare the difference in recurrence rate at 3 months postoperatively between the two groups.

Secondary outcomes

  1. Mortality rate within 3 months after operation

    Time frame: From operation up to 3 months postoperatively

    To compare the difference in mortality rate at 3 months postoperatively between the two groups.

  2. Change of Modified Rankin Scale (MRS) between groups from baseline to 3 months after operation

    Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation

    Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death.

  3. Change of Markwalder Grading Scale (MGS) between groups from baseline to 3 months after operation

    Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation

    Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma.

  4. Change of Quality of life assessment (EQ-5D-5L) between groups from baseline to 3 months after operation

    Time frame: "Day 0", "Day 2", "Month 1", "Month3" after operation

    A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including 'No problems-Slight problems-Moderate problems-Severe problems-Unable to'postoperatively between the two groups.

  5. Rate of complications and adverse events between groups within 3 months

    Time frame: From operation up to 3 months postoperatively

    Rate of complications and adverse events between the two groups within 3 months.

  6. Postoperative drainage time

    Time frame: immediately after the procedure

    To compare the difference in length of postoperative drainage between the two groups.

  7. Length of hospitalization

    Time frame: immediately after the procedure

    To compare the difference in length of hospitalization between the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Wu, MD

CONTACT

[email protected]

18301674233

Yu Yan, MB

CONTACT

[email protected]

13701141637

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Official study title

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

Acronym: URANUS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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