title: Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01869855; https://clinicaltrials.gov/ct2/show/NCT01869855 (Archived by WebCite at http://www.webcitation.org/6fNK4Jlxk).
authors.affiliation: Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland, Aarau, Switzerland. jehuda.soleman@gmail.com.
authors.forename: Jehuda
authors.identifier: http://orcid.org/0000-0003-1900-9286
authors.initials: J
authors.lastname: Soleman
authors.forename: Katharina
authors.identifier: http://orcid.org/0000-0002-4938-6974
authors.initials: K
authors.lastname: Lutz
authors.forename: Sabine
authors.identifier: http://orcid.org/0000-0002-1150-0962
authors.initials: S
authors.lastname: Schaedelin
authors.forename: Luigi
authors.identifier: http://orcid.org/0000-0002-1971-5095
authors.initials: L
authors.lastname: Mariani
authors.forename: Javier
authors.identifier: http://orcid.org/0000-0002-5375-3087
authors.initials: J
authors.lastname: Fandino
keywords: burr-hole trepanation; chronic subdural hematoma; drain; hematoma; recurrent hematoma