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Published on: March 26, 2019
Use of Subperiosteal Drain Versus Subdural Drain in Chronic Subdural Hematomas Treated With Burr-Hole Trepanation:
Jehuda Soleman1, Katharina Lutz, Sabine Schaedelin
1Department of Neurosurgery, Kantonsspital Aarau, Aarau, Switzerland, Aarau, Switzerland. jehuda.soleman@gmail.com.
Insights
This study compares subperiosteal drains (SPD) versus subdural drains (SDD) for chronic subdural hematoma (cSDH) after burr-hole surgery. Results will guide evidence-based practice for this common neurosurgical condition.
Area of Science:
- Neurosurgery
- Clinical Trials
- Medical Devices
Background:
- Chronic subdural hematoma (cSDH) is a frequent neurosurgical condition in the elderly, associated with significant morbidity and mortality.
- Subdural drains (SDD) reduce recurrence and mortality for cSDH at 6 months post-surgery.
- Current neurosurgical practice lacks evidence-based guidelines differentiating between SDD and subperiosteal drains (SPD).
Purpose of the Study:
- To compare reoperation rates in patients with cSDH undergoing burr-hole trepanation with either an SPD or an SDD.
- To provide evidence for optimal drain selection in cSDH surgical management.
Main Methods:
- A prospective, noninferiority, multicenter randomized controlled trial.
- Inclusion of 220 adult patients with symptomatic cSDH confirmed by imaging.
- Random allocation to either SPD or SDD group, with reoperation within 12 months as the primary endpoint.
Main Results:
- Patient recruitment initiated in April 2013.
- Study completion anticipated by late 2016 or early 2017.
- Ethics approval obtained; research is investigator-initiated.
Conclusions:
- Evidence-based recommendations for cSDH operative treatment are currently limited.
- Study results are expected to inform clinical practice for the growing cSDH patient population.
- Findings may lead to more efficient cSDH treatment and reduced postoperative complications.
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).
