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

Jehuda Soleman, Katharina Lutz, Sabine Schaedelin, Luigi Mariani, Javier Fandino, Jehuda Soleman, Katharina Lutz, Sabine Schaedelin, Luigi Mariani, Javier Fandino

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://ichgcp.net/clinical-trials-registry/NCT01869855 (Archived by WebCite at http://www.webcitation.org/6fNK4Jlxk).

Keywords: burr-hole trepanation; chronic subdural hematoma; drain; hematoma; recurrent hematoma.

Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Study workflow mRS: modified Rankin Scale, GOS: Glasgow Outcome Scale, CT: computer tomography, MRI: magnetic resonance imaging.
Figure 2
Figure 2
Sample size calculations.

References

    1. Markwalder T, Steinsiepe K, Rohner M, Reichenbach W, Markwalder H. The course of chronic subdural hematomas after burr-hole craniostomy and closed-system drainage. J Neurosurg. 1981 Sep;55(3):390–396. doi: 10.3171/jns.1981.55.3.0390.
    1. Santarius T, Kirkpatrick P, Ganesan D, Chia H, Jalloh I, Smielewski P, Richards H, Marcus H, Parker R, Price S, Kirollos R, Pickard J, Hutchinson PJ. Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial. Lancet. 2009 Sep 26;374(9695):1067–1073. doi: 10.1016/S0140-6736(09)61115-6.
    1. Soleman J, Taussky P, Fandino J, Muroi C. Evidence-Based Treatment of Chronic Subdural Hematoma. In: Sadaka F, editor. Traumatic Brain Injury. Rijeca, Croatia: InTech; 2014.
    1. Baechli H, Nordmann A, Bucher H, Gratzl O. Demographics and prevalent risk factors of chronic subdural haematoma: results of a large single-center cohort study. Neurosurg Rev. 2004 Oct;27(4):263–266. doi: 10.1007/s10143-004-0337-6.
    1. Bellut D, Woernle C, Burkhardt J, Kockro R, Bertalanffy H, Krayenbühl N. Subdural drainage versus subperiosteal drainage in burr-hole trepanation for symptomatic chronic subdural hematomas. World Neurosurg. 2012 Jan;77(1):111–118. doi: 10.1016/j.wneu.2011.05.036.
    1. Taussky P, Fandino J, Landolt H. Number of burr holes as independent predictor of postoperative recurrence in chronic subdural haematoma. Br J Neurosurg. 2008 Apr;22(2):279–282. doi: 10.1080/02688690701818885.
    1. Weigel R, Schmiedek P, Krauss JK. Outcome of contemporary surgery for chronic subdural haematoma: evidence based review. J Neurol Neurosurg Psychiatry. 2003 Jul;74(7):937–943.
    1. Gelabert-González M, Iglesias-Pais M, García-Allut A, Martínez-Rumbo R. Chronic subdural haematoma: surgical treatment and outcome in 1000 cases. Clin Neurol Neurosurg. 2005 Apr;107(3):223–229. doi: 10.1016/j.clineuro.2004.09.015.
    1. Gazzeri R, Galarza M, Neroni M, Canova A, Refice G, Esposito S. Continuous subgaleal suction drainage for the treatment of chronic subdural haematoma. Acta Neurochir (Wien) 2007;149(5):487–493. doi: 10.1007/s00701-007-1139-8.
    1. Zumofen D, Regli L, Levivier M, Krayenbühl N. Chronic subdural hematomas treated by burr hole trepanation and a subperiostal drainage system. Neurosurgery. 2009 Jun;64(6):1116–1121. doi: 10.1227/.
    1. Kaliaperumal C, Khalil A, Fenton E, Okafo U, Kaar G, O'Sullivan M, Marks C. A prospective randomised study to compare the utility and outcomes of subdural and subperiosteal drains for the treatment of chronic subdural haematoma. Acta Neurochir (Wien) 2012 Nov;154(11):2083–2088. doi: 10.1007/s00701-012-1483-1.
    1. Almenawer S, Farrokhyar F, Hong C, Alhazzani W, Manoranjan B, Yarascavitch B, Arjmand P, Baronia B, Reddy K, Murty N, Singh Sheila. Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients. Ann Surg. 2014 Mar;259(3):449–457. doi: 10.1097/SLA.0000000000000255.

Source: PubMed

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