Department of Neurology, UCLA, Los Angeles, California 90095-1769, USA.
Epilepsia. 2010 Oct;51(10):1978-86. doi: 10.1111/j.1528-1167.2010.02641.x.
To describe the trial design for the multicenter Early Randomized Surgical Epilepsy Trial (ERSET). Patients with pharmacoresistant epilepsy are generally referred for surgical treatment an average of two decades after onset of seizures, often too late to avoid irreversible disability. ERSET was designed to assess the safety and efficacy of early surgical intervention compared to continued pharmacotherapy.
ERSET is a randomized controlled, parallel group clinical trial with blinded outcome adjudication. Participants are patients with mesial temporal lobe epilepsy (MTLE) older than the age of 12 who have had pharmacoresistant seizures for not >2 years and are determined by detailed evaluation to be surgical candidates prior to randomization. The primary outcome measure is seizure freedom in the second year of a 2-year follow-up period. Health-related quality of life (HRQOL), neurocognitive function, ancillary outcomes, and adverse events were also measured.
Significant methodologic problems addressed by the study design included the following: recruitment of participants early in the course of epilepsy; establishment of operational definitions for "pharmacoresistant" and "early"; and standardization of diagnostic testing, medical treatment, and surgical interventions across multiple centers.
Rigorous trial designs to assess surgical interventions in epilepsy are necessary to provide evidence to guide treatment. This article is the first of a series; trial results will be reported in subsequent publications.
描述多中心早期随机手术癫痫试验（ERSET）的试验设计。抗药性癫痫患者通常在发病后平均 20 年才被推荐进行手术治疗，往往为时已晚，无法避免不可逆转的残疾。ERSET 的目的是评估早期手术干预与继续药物治疗相比的安全性和疗效。
ERSET 是一项随机对照、平行组临床试验，采用盲法结局评估。参与者为年龄大于 12 岁、患有耐药性癫痫发作不超过 2 年且在随机分组前通过详细评估确定为手术候选者的内侧颞叶癫痫（MTLE）患者。主要结局测量指标是 2 年随访期内的无发作。还测量了健康相关生活质量（HRQOL）、神经认知功能、辅助结局和不良事件。
该研究设计解决了以下重要方法学问题：在癫痫病程早期招募参与者；为“耐药性”和“早期”建立操作性定义；以及在多个中心标准化诊断测试、药物治疗和手术干预。
评估癫痫手术干预的严格试验设计对于提供指导治疗的证据是必要的。本文是一系列文章中的第一篇，试验结果将在后续出版物中报告。
