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Randomized Controlled Trial Comparative Study
Use of drains versus no drains after burr-hole evacuation of chronic subdural haematoma: a randomised controlled trial.
- Thomas Santarius, Peter J Kirkpatrick, Dharmendra Ganesan, Hui Ling Chia, Ibrahim Jalloh, Peter Smielewski, Hugh K Richards, Hani Marcus, Richard A Parker, Stephen J Price, Ramez W Kirollos, John D Pickard, and Peter J Hutchinson.
- Department of Neurosurgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.
- Lancet. 2009 Sep 26; 374 (9695): 1067-73.
BackgroundChronic subdural haematoma causes serious morbidity and mortality. It recurs after surgical evacuation in 5-30% of patients. Drains might reduce recurrence but are not used routinely. Our aim was to investigate the effect of drains on recurrence rates and clinical outcomes.MethodsWe did a randomised controlled trial at one UK centre between November, 2004, and November, 2007. 269 patients aged 18 years and older with a chronic subdural haematoma for burr-hole drainage were assessed for eligibility. 108 were randomly assigned by block randomisation to receive a drain inserted into the subdural space and 107 to no drain after evacuation. The primary endpoint was recurrence needing redrainage. The trial was stopped early because of a significant benefit in reduction of recurrence. Analyses were done on an intention-to-treat basis. This study is registered with the International Standard Randomised Controlled Trial Register (ISRCTN 97314294).FindingsRecurrence occurred in ten of 108 (9.3%) people with a drain, and 26 of 107 (24%) without (p=0.003; 95% CI 0.14-0.70). At 6 months mortality was nine of 105 (8.6%) and 19 of 105 (18.1%), respectively (p=0.042; 95% CI 0.1-0.99). Medical and surgical complications were much the same between the study groups.InterpretationUse of a drain after burr-hole drainage of chronic subdural haematoma is safe and associated with reduced recurrence and mortality at 6 months.FundingAcademy of Medical Sciences, Health Foundation, and NIHR Biomedical Research Centre (Neurosciences Theme).
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