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Background <p>Chronic subdural hematoma (CSDH), a highly prevalent neurosurgical condition predominantly affecting the elderly, demonstrates an incidence of 58.1/100,000 person-years in individuals ≥ 65&#xa0;years, escalating to 127/100,000 among octogenarians. Driven by global demographic aging and anticoagulant utilization, its population-level incidence is projected to reach 17.4/100,000 by 2030. The standard surgical intervention—burr hole craniotomy with intraoperative irrigation and closed subdural drainage implantation—carries a documented recurrence rate of 5–33%, where residual hematoma volume constitutes a well-established independent recurrence predictor. Meta-analysis indicates endoscopically guided drainage may reduce recurrence through optimized hematoma evacuation, though robust clinical validation of its therapeutic benefit remains insufficient.</p> Methods <p>This prospective, multicenter, open-label, randomized controlled trial employing blinded endpoint assessment will enroll 770 participants aged 18–90&#xa0;years with radiologically verified symptomatic CSDH. Eligible patients will be randomized to receive neuroendoscopy-assisted drainage (intervention cohort) or burr hole craniotomy drainage (control cohort), with the primary endpoint defined as the occurrence of recurrent hematoma necessitating reintervention within 3 postoperative months. Secondary outcomes comprise postoperative hematoma volume, thickness, and midline shift; neurological function evaluated using standardized assessment scales; quality-of-life measures quantified via validated instruments; catheter indwelling time for subdural drainage; total hospitalization length of stay; all-cause mortality; and incidence of procedure-associated complications.</p> Discussion <p>This study aims to validate the efficacy and safety of neuroendoscopy-assisted drainage for reducing recurrence rates and improving clinical outcomes in CSDH patients.</p> Trial registration <p>ClinicalTrials.gov, <a href="https://clinicaltrials.gov/study/NCT07144423">NCT07144423</a>. Registered on Aug 27, 2025.</p>

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Neuroendoscopy-assisted drainage versus burr hole drainage for chronic subdural hematoma (URANUS): study protocol for a multicenter randomized controlled trial

  • 期刊论文

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  • 发表日期：

    2026年3月17日

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  • Liang Wu,
  • Yu Yan,
  • Yu Deng,
  • Yunfei Li,
  • Weiming Liu,
  • Guoyi Gao

摘要

Background

Chronic subdural hematoma (CSDH), a highly prevalent neurosurgical condition predominantly affecting the elderly, demonstrates an incidence of 58.1/100,000 person-years in individuals ≥ 65 years, escalating to 127/100,000 among octogenarians. Driven by global demographic aging and anticoagulant utilization, its population-level incidence is projected to reach 17.4/100,000 by 2030. The standard surgical intervention—burr hole craniotomy with intraoperative irrigation and closed subdural drainage implantation—carries a documented recurrence rate of 5–33%, where residual hematoma volume constitutes a well-established independent recurrence predictor. Meta-analysis indicates endoscopically guided drainage may reduce recurrence through optimized hematoma evacuation, though robust clinical validation of its therapeutic benefit remains insufficient.

Methods

This prospective, multicenter, open-label, randomized controlled trial employing blinded endpoint assessment will enroll 770 participants aged 18–90 years with radiologically verified symptomatic CSDH. Eligible patients will be randomized to receive neuroendoscopy-assisted drainage (intervention cohort) or burr hole craniotomy drainage (control cohort), with the primary endpoint defined as the occurrence of recurrent hematoma necessitating reintervention within 3 postoperative months. Secondary outcomes comprise postoperative hematoma volume, thickness, and midline shift; neurological function evaluated using standardized assessment scales; quality-of-life measures quantified via validated instruments; catheter indwelling time for subdural drainage; total hospitalization length of stay; all-cause mortality; and incidence of procedure-associated complications.

Discussion

This study aims to validate the efficacy and safety of neuroendoscopy-assisted drainage for reducing recurrence rates and improving clinical outcomes in CSDH patients.

Trial registration

ClinicalTrials.gov, NCT07144423. Registered on Aug 27, 2025.