Trials · 2026
Neuroendoscopy-assisted drainage versus burr hole drainage for chronic subdural hematoma (URANUS): study protocol for a multicenter randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Wu Liang, Yan Yu, Deng Yu, Li Yunfei, Liu Weiming, Gao Guoyi, URANUS Trial Collaborators
Аннотация
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.
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.