@Article{info:doi/10.2196/resprot.5339,
author="Soleman, Jehuda
and Lutz, Katharina
and Schaedelin, Sabine
and Mariani, Luigi
and Fandino, Javier",
title="Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2016",
month="Apr",
day="08",
volume="5",
number="2",
pages="e38",
keywords="chronic subdural hematoma; drain; hematoma; recurrent hematoma; burr-hole trepanation",
abstract="Background: Chronic 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. Objective: The 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. Methods: This 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. Results: This 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. Conclusions: To 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 Registration: ClinicalTrials.gov NCT01869855; https://clinicaltrials.gov/ct2/show/NCT01869855 (Archived by WebCite at http://www.webcitation.org/6fNK4Jlxk) ",
issn="1929-0748",
doi="10.2196/resprot.5339",
url="http://www.researchprotocols.org/2016/2/e38/",
url="https://doi.org/10.2196/resprot.5339",
url="http://www.ncbi.nlm.nih.gov/pubmed/27059872"
}