Active subperiosteal versus passive subdural 24-hour drainage following single burr hole evacuation of chronic subdural haematoma (the SUPERDURA trial): protocol for a multicentre, randomised non-inferiority trial
Abstract
Introduction The main treatment of chronic subdural haematoma (CSDH) is neurosurgical evacuation with subsequent drainage. However, consensus on optimal drain modality and placement is lacking. Aim To examine whether 24-hour active subperiosteal drainage is non-inferior to 24-hour passive subdural drainage after a single burr hole evacuation of a symptomatic CSDH. Methods and analysis SUPERDURA is a multicentre randomised non-inferiority trial encompassing all neurosurgical units in Denmark. Adult patients with symptomatic CSDH admitted to a Danish neurosurgical unit for single burr hole evacuation will be screened for inclusion. Patients who are not able to give informed consent, and patients with recurrent CSDH, known cerebrospinal fluid abnormalities and other known brain pathologies will be excluded. Patients with bilateral CSDH will be registered as one case and treated similarly on both sides. Before surgical haematoma evacuation, patients will be randomised to 24-hour passive subdural drainage or 24-hour active subperiosteal drainage. The patients included and the two study statisticians will be blinded. The primary outcome is a composite outcome of 90-day mortality and symptomatic CSDH recurrence. Secondary outcomes are 90-day simplified modified Rankin score, 90-day serious adverse events and complications related to surgery or occurring during admission, including intracerebral haemorrhage due to misplaced drains, acute subdural haematoma, tension pneumocephalus,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 354 participants or records.
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