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Children and adolescents with drug-resistant epilepsy are at increased risk for poor long-term intellectual and psychosocial outcomes, along with a poor health-related quality of life.1–3 In this form of recalcitrant epilepsy, appropriate surgical management is often undertaken with the goal of reducing or stopping seizures, but there is limited evidence from randomized trials showing the benefit in this age group.
The region of the cerebrum that is subjected to surgery depends on the localization of the origin of seizures in the cerebral cortex and the functional importance of the surrounding brain tissue. These factors are determined on presurgical evaluation, including simultaneously acquired video electroencephalographic (video EEG) recordings and structural and functional imaging of the brain. The type of surgery is dependent on the underlying cause of epilepsy and may include resection of the mesial temporal lobe or other regions of the cerebral cortex, excision of a focal lesion or developmental malformation, sectioning of the corpus callosum (corpus callosotomy), disconnection of a part of the cerebral cortex, or disconnection of an entire hemisphere (hemispherotomy). Some of these procedures necessarily result in neurologic deficits.
Two randomized trials of temporal lobectomy for drug-resistant epilepsy included only adults.4,5 A Cochrane review of epilepsy surgery included only four trials that had more than 30 participants, and these trials involved patients in all age groups.6 Three of these trials compared different surgical techniques or compared different extents of surgical resection, but only one4 randomly assigned patients to surgical and medical groups. A meta-analysis of uncontrolled studies that compared seizure outcomes of surgeries in children showed that 74% of those with brain lesions and 45% of those without lesions had become seizure-free at the 1-year follow-up.7 In a retrospective analysis involving 142 children who had undergone surgery for drug-resistant epilepsy at a mean age of 9.8 years between 2000 and 2011 at our center, 79.3% were free from disabling seizures after a mean follow-up of approximately 4 years.8 To follow up on these results, we performed a trial involving children and adolescents with drug-resistant epilepsy to compare epilepsy surgery with continued medical therapy alone in patients on a waiting list for surgery.
Methods
Trial Design and Oversight
The trial was conducted from...