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) |
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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: |
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Last Modified: | 29 Sep 2020 10:52 |
Deposited On: | 29 Sep 2020 10:52 |
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