Thomas Santarius MRCS a, Peter J Kirkpatrick FMedSci a, Dharmendra Ganesan FRCS[SN] a, Hui Ling Chia MMed a, Ibrahim Jalloh MRCS a, Peter Smielewski PhD a, Hugh K Richards PhD a, Hani Marcus MRCS a, Richard A Parker MSc b, Stephen J Price FRCS[SN] a, Ramez W Kirollos FRCS[SN] a, Prof John D Pickard FMedSci a, Peter J Hutchinson FRCS[SN] a The Lancet, Volume 374, Issue 9695, Pages 1067 – 1073, 26 September 2009
Background
Chronic 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.
Methods
We 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).
Findings
Recurrence 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.
Interpretation
Use of a drain after burr-hole drainage of chronic subdural haematoma is safe and associated with reduced recurrence and mortality at 6 months.
Funding
Academy of Medical Sciences, Health Foundation, and NIHR Biomedical Research Centre (Neurosciences Theme).
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