Abstract
BackgroundChronic subdural hematoma (cSDH) is one of the most frequent neurosurgical conditions affecting elderly people and is associated with substantial morbidity and mortality. The use of a subdural drain (SDD) after burr-hole trepanation for cSDH was proven to reduce recurrence and mortality at 6 months. To date in neurosurgery practice, evidence-based guidelines on whether an SDD or subperiosteal drain (SPD) should be used do not exist. Currently both methods are being practiced depending on the institute and/or the practicing neurosurgeon.ObjectiveThe aim of this study is to compare the reoperation rates after burr-hole trepanation and insertion of an SPD or SDD in patients with cSDH.MethodsThis is a prospective, noninferiority, multicenter, randomized controlled trial designed to include 220 patients over the age of 18 years presenting with a symptomatic cSDH verified on cranial computed tomography or magnetic resonance imaging who are to undergo surgical evacuation with burr-hole trepanation. After informed consent is obtained, patients are randomly allocated to an SPD or SDD group. The primary endpoint is recurrence indicating a reoperation within 12 months.ResultsThis research is investigator-initiated and has received ethics approval. Patient recruitment started in April 2013, and we expect all study-related activities to be completed by the end of 2016 or beginning of 2017.ConclusionsTo date, evidence-based recommendations concerning the operative treatment of cSDH are sparse. Results of this research are expected to have applications in evidence-based practice for the increasing number of patients suffering from cSDH and possibly lead to more efficient treatment of this disease with fewer postoperative complications.Trial RegistrationClinicalTrials.gov NCT01869855; https://clinicaltrials.gov/ct2/show/NCT01869855 (Archived by WebCite at http://www.webcitation.org/6fNK4Jlxk)
Highlights
Serious adverse events x x x x x mRS: modified Rankin Scale GOS: Glasgow Outcome Scale LOS: length of stay CT: computer tomography MRI: magnetic resonance imaging Post-OP: postoperative 1 procedure date, type of inserted drainage, cross-over patients, blood thinners during or before the procedure and if they were reverted medically of through time, presence of membranes in the hematoma cavity, communication between both burr-holes will be recorded in the CRF 2 mild line shift measured at the level of the foramina of Monro, maximal hematoma width, hematoma side will be recorded in the CRF 3 mild line shift measured at the level of the foramina of Monro, maximal hematoma width, new intracranial bleeding will be recorded in the CRF
In case of neurological worsening CT scans will be repeated as required, yet these results will be not recorded in the CRF
Summary
Serious adverse events x mRS: modified Rankin Scale GOS: Glasgow Outcome Scale LOS: length of stay CT: computer tomography MRI: magnetic resonance imaging Post-OP: postoperative 1 procedure date, type of inserted drainage (subdural or subperiosteal), cross-over patients, blood thinners during or before the procedure and if they were reverted medically of through time, presence of membranes in the hematoma cavity, communication between both burr-holes will be recorded in the CRF 2 mild line shift measured at the level of the foramina of Monro, maximal hematoma width, hematoma side will be recorded in the CRF 3 mild line shift measured at the level of the foramina of Monro, maximal hematoma width, new intracranial bleeding will be recorded in the CRF.
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