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Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial

Soleman, Jehuda and Lutz, Katharina and Schaedelin, Sabine and Mariani, Luigi and Fandino, Javier. (2016) Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation: Study Protocol for a Randomized Controlled Trial. JMIR Research Protocols, 5 (2). e38.

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Official URL: https://edoc.unibas.ch/74445/

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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).
Faculties and Departments:03 Faculty of Medicine > Bereich Operative Fächer (Klinik) > Kopfbereich > Neurochirurgie (Guzman)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Operative Fächer (Klinik) > Kopfbereich > Neurochirurgie (Guzman)
03 Faculty of Medicine > Bereich Operative Fächer (Klinik) > Kopfbereich > Neurochirurgie (Mariani)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Operative Fächer (Klinik) > Kopfbereich > Neurochirurgie (Mariani)
UniBasel Contributors:Soleman, Jehuda
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:JMIR Publications
e-ISSN:1929-0748
Note:Publication type according to Uni Basel Research Database: Journal article
Identification Number:
Last Modified:29 Sep 2020 10:52
Deposited On:29 Sep 2020 10:52

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