跳至主要内容
临床试验/NCT02310516
NCT02310516Unknown不适用

Prospective Evaluation of the Impact of Pre-operative Device on the Personal Experience of Brain Awake Surgery: Comparative Study, Randomized

Assistance Publique Hopitaux De Marseille1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR)

研究概览

简要总结

The brain awake surgery has recently boomed in neurosurgical oncology but also in epilepsy surgery. The goal of awake surgery is to allow a more precise localization of sensorimotor functions, languages and cognitive to better respect them. Indeed, the interindividual anatomo-functional variations, the lack of specificity of functional explorations radiological magnetic or nuclear, as well as the reorganization of the areas involved in these functions (mechanisms of brain plasticity) in epileptic patients or patients with cerebral tumor do not allow to identify them in preoperatively. Brain awake surgery allows an analysis and a precise real-time identification of areas and networks involved in these functions through a direct electrical stimulation (inhibitory or activatory). Thus, this surgical technique has become a gold standard in surgery of brain lesions located in functional areas.

However, although the brain awake surgery has been practiced since many years, the confidentiality of these informations until recent years explains probably that very little data to be available on the personal experience of this procedure by patients. Studies that have analyzed the perception of the patient or the satisfaction of the patient after surgery in awake conditions were retrospective and included few patients. The investigators experience of lived of this surgery that the investigators have developed in the investigators team since over four years is that on the whole awake surgery is well tolerated if adequate explanations are provided preoperatively and if a minimum of preoperative precautions are observed.

Thus, the investigators have decided to develop a preoperative device that could improve personal experience and well-being of patients undergoing this surgical approach.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Subject with a low grade glioma targeted for intervention in the awake brain surgery;
  • •Subject able to complete a self-administered questionnaire;
  • •Subjects who have signed a written informed consent and agreeing to abide by the instructions of the protocol

排除标准

  • •Minor, pregnant or lactating women, not affiliated to the social security system;
  • •Subject severe respiratory failure;
  • •Subjects treated with antipsychotic (neuroleptic or lithium);
  • •Subjects with cognitive impairment degenerative previously documented (Alzheimer, dementia other);
  • •subject active addict;
  • •Subject with personal psychiatric history;

研究组 & 干预措施

Patient with preoperative device

Experimental

patients undergoing brain awake surgery with adequate explanations which are provided preoperatively. Preoperative device corresponds to a pre/ perioperative coaching involving the provision of a comprehensive information support on the awake surgery (short video and information brochure) and an interview with an operating room nurse

干预措施: preoperative adequate explanations about awake surgery (Device)

Patient with standard procedure

Active Comparator

patients undergoing brain awake surgery with standard procedure (without adequate explanations)

干预措施: no preoperative explanation (Other)

结局指标

主要结局

Perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR)

时间窗: 6 days

perioperative experience evaluated postoperatively using a self-administered questionnaire (EVAN LR)

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 (1)

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