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临床试验/NCT06035965
NCT06035965已完成不适用

Comparison of Quality of Life and Changes Experienced by Patients After Epilepsy Surgery, With Long-term Epileptological Objective Results

University Hospital, Toulouse2 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2023年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
151
试验地点
2
主要终点
Evaluation of the changes felt by patients

研究概览

简要总结

Epilepsy is one of the most common chronic neurological diseases. According to data from the World Health Organization (WHO), it affects 0.5 to 1% of the population, or around 70 million people world-wide and around 600,000 in France. There are several more or less severe forms of epilepsy depending on the type of epileptic seizures and the frequency of these seizures. About 30% of epileptic patients respond poorly to well-conducted medical treatment, which makes the number of so-called "drug-resistant" patients estimated at between 100,000 and 150,000 patients.

Epilepsy surgery is possible in some cases of drug-resistant epilepsy and can lead to complete seizure control. Beyond the impact on the control of seizures, surgery can have an impact on the lives of patients at the psychological, emotional and cognitive level, with consequences on their socio-professional but also personal life. Thus the impact on the daily life of patients after epilepsy surgery can vary greatly from one patient to another and the personal feelings of operated patients do not always seem to correspond to the objective elements collected by doctors. 2.3 The investigators want to retrospectively assess the satisfaction and quality of life of patients operated on for more than 2 years based on their epileptological results (frequency of seizures).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient operated in the context of epilepsy surgery dating back more than 2 years in the epileptology center of the Toulouse University Hospital.
  • Patient covered by a social security scheme.
  • Patient having given his non-objection to participate in the research.

排除标准

  • Minor under the age of 15 at the time of the questionnaires.
  • Serious psychiatric pathology unrelated to epilepsy surgery.
  • Severe intellectual disability limiting responses to self-questionnaires.
  • Language barrier.
  • Patients under guardianship and protection of justice.

结局指标

主要结局

Evaluation of the changes felt by patients

时间窗: 2 years

Evaluate the changes felt by patients more than 2 years after surgery in the context of drug-resistant epilepsy using a new questionnaire created by the epileptology team of the Toulouse University Hospital. The rating of the responses is distributed between 0 and 100 (0 = very negative change, 50 = no change and 100 = very positive change).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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