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Protocol of a prospective multicenter randomized controlled trial of robot-assisted stereotactic lesioning in the treatment of focal drug-resistant epilepsy

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机构: [1]Capital Med Univ, Sanbo Brain Hosp, Dept Neurosurg, 50 Yikesong Rd, Beijing 100093, Peoples R China [2]Capital Med Univ, Xuanwu Hosp, Dept Neurosurg, 45 Changchun St, Beijing 100053, Peoples R China [3]Capital Med Univ, Beijing Tiantan Hosp, Dept Neurosurg, 119 South 4th Ring West Rd, Beijing 10007, Peoples R China [4]Capital Med Univ, Sanbo Brain Hosp, Dept Neurol, 50 Yikesong Rd, Beijing 100093, Peoples R China
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关键词: Drug-resistant epilepsy Robot-assisted stereotactic lesioning Randomized controlled trial

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BackgroundThis protocol describes the design of a multicenter randomized controlled trial of robot-assisted stereotactic lesioning versus epileptogenic foci resection. Typical causes of focal epilepsy include hippocampal sclerosis and focal cortical dysplasia. These patients usually present with drug resistance and require surgical treatment. Although epileptogenic foci resection is still the most commonly used treatment for such focal epilepsy, there is increasing evidence that epileptogenic focus resection may lead to neurological impairment. The treatment of epilepsy with a robot-assisted stereotactic lesioning mainly includes two new minimally invasive surgical methods: radiofrequency thermocoagulation (RF-TC) and laser interstitial thermal therapy (LITT). Seizure-free is less likely to be achieved by these two procedures, but neurologic preservation is better. In this study, we aimed to compare the safety and efficacy of RF-TC, LITT, and epileptogenic foci resection for focal drug-resistant epilepsy.MethodsThis is a multicenter, three-arm, randomized controlled clinical trial. The study will include patients older than 3 years of age with epilepsy who have had medically refractory seizures for at least 2 years and are eligible for surgical treatment with an epileptogenic focus as determined by multidisciplinary evaluation prior to randomization. The primary outcome measure is seizure outcome (quantified by seizure remission rate) at 3-month, 6-month, and 1-year follow-up after treatment. Postoperative neurologic impairment, spectrum distribution change of video electroencephalogram, quality of life, and medical costs will also be assessed as secondary outcomes.

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出版当年[2022]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
最新[2023]版:
大类 | 4 区 医学
小类 | 4 区 医学:研究与实验
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出版当年[2021]版:
Q4 MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版:
Q3 MEDICINE, RESEARCH & EXPERIMENTAL

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第一作者机构: [1]Capital Med Univ, Sanbo Brain Hosp, Dept Neurosurg, 50 Yikesong Rd, Beijing 100093, Peoples R China
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