Use of Subperiosteal Drain versus Subdural Drain in Chronic Subdural Hematomas Treated with Burr-Hole Trepanation: A Randomized Controlled Trial

Introduction: The use of a subdural drain after burr-hole drainage of chronic subdural hematoma (cSDH) was proven to reduce recurrence and mortality at 6 months. To date in neurosurgery practice evidence based guidelines on what kind of drain should be used, namely a subdural or subperiosteal drain, do not exist. Currently both methods are being practiced depending on the institute and/or the practicing neurosurgeon. The aim of this study is to compare in a randomized and controlled fashion the recurrence and complication rate of both methods.

Methods: In this single-center block-randomized controlled trial recruitment began in April 2013. Patients aged 18 years or older who present to the department of neurosurgery at Kantonsspital Aarau, Aarau, Switzerland, with symptomatic chronic subdural hematoma proven by CT or MRI scan for burr-hole drainage are eligible for inclusion. Patients are excluded once the surgeon decides, based on intraoperative conditions, to perform a craniotomy; the chronic subdural hematoma is caused by another underlying illness (e.g., caused by over-drainage of a shunt); or the patient does not consent. The primary endpoint is recurrence needing redrainage. The secondary endpoints are clinical and radiologic outcome at discharge and at 6 weeks and clinical outcome at one year. Analyses will be done on an intention-to-treat basis. The sample size was calculated on the basis of published work. We estimated that a sample size of 150 in each group (80% power) was needed to show a reduction of 15% in rate of recurrence (α=0.05). The study is registered with the ClinicalTrials.gov register (NCT01869855) and the protocol was approved by the Northwest and Central Ethics Committee of Switzerland (EKNZ, approval number: AG/SO 2013/001).

Conclusion: So far 44 patients were recruited for this randomized controlled trial at our institution. We encourage further neurosurgical institutes to participate in this ongoing trail. Preliminary results will be presented.