Author(s): Jenkinson M.D.; Gamble C.; Marson A.
Source: British Journal of Neurosurgery; 2017; vol. 31 (no. 3); p. 388
Publication Date: 2017
Publication Type(s): Conference Abstract
Available in full text at British Journal of Neurosurgery – from Informa Healthcare
Abstract:Aim: Meningioma are the commonest primary brain tumour. Approximately 70% of patients are seizure naive at presentation. Prophylactic anti-epileptic drugs (AED) are routinely prescribed despite a lack of evidence of benefit. A trial is proposed to determine whether prophylactic AED reduce the risk of developing epilepsy in seizure-naive patients following surgical resection of meningioma. Method Design: Multi-centre randomized controlled trial Setting: regional neurosurgical centres in UK Population: seizure-naive newly-diagnosed supratentorial meningioma Intervention: prophylactic AED (Levitoracetam 500mg BD for 2 weeks) Comparator: no treatment (current standard of care) Outcome: time to first seizure Result: Using an estimate of 10% post-operative seizure rate in the control group and 5% in the prophylaxis group then a 0.05 level two-sided log rank test with 80% power would require 435 patients in each arm (870 in total). Factors related to risk of developing seizure would be investigated including tumour location and volume, peri-tumoural oedema, post-operative haematoma/infection and MRI features. Neuro-cognitive function and quality of life would be assessed. Health economic analysis would be performed. Conclusion: STOP ‘EM would provide class I evidence on the role of prophylactic AED for seizure naive patients undergoing surgical resection of supratentorial meningioma and would inform treatment guidelines and NHS policy.
Database: EMBASE