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临床试验/NCT03503487
NCT03503487已完成不适用

Surgical Planning and Informed Consent

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Evaluation of the comprehension of the benefits/risks of the intervention

研究概览

简要总结

New devices for anatomic studies and 3-D visualization have proven to be useful for pre-operative surgical planning and intra-operative procedures; the hypothesis of our study is that, in this specific case scenario, Surgical Theater and Vesalius (two devices available at the Besta NeuroSim Center, Foundation I.R.C.C.S. Neurological Institute Carlo Besta) can improve doctor-patient communication during the process of obtaining informed consent: through tridimensional representation of anatomic structures of the brain, these devices are able to help patients understand better their own anatomy and the surgical approach to their disease.

The aim of our study is therefore to understand whether this high-technology 3D planning, used as a tool to optimize patient-doctor communication, can effectively improve patients' understanding of the disease and the surgical procedure they will be going through (for which they are supposed to sign the consent), as well as the benefits, the risks and all the possible complications that can derive form surgery.

Surgical Theater and Vesalius may be of great help: thanks to the case-specific 3D reconstruction of the patient's anatomy, the explanation of the surgical procedure could be customized for each different person, considering that anyone has certain unique individual features that a regular standardized system could not possibly take into account.

详细描述

Informed consent is the authorisation of an activity based on the understanding of what that activity entails in the absence of control by others. In surgery this process needs the comprehension of the benefits and the risks of the operation. Despite this, it has been argued that most surgeons do not devote adequate importance and time to this step in their daily practice; sometimes they are just afraid of scaring the patients with too many unnecessary details. Surgeons then might hide themselves behind legal booklets that should provide all information; too often though, patients do not fully realise their diseases and the possible outcomes.

New devices for anatomical studies and 3D visualization have proven to be useful for preoperative surgical planning and intra-operative procedures; the hypothesis of our study is that Surgical Theater and Vesalius (two new-generation, immersive, 3D imaging visualizers) can improve doctor-patient communication during the process of obtaining informed consent: through the tridimensional representation of anatomic structures of the brain, these devices are able to help patients better understand their anatomy, the surgical approach for their disease and possible complications.

In a prospective, randomized controlled pilot study, 40 patients undergoing neurosurgery for intracranial tumours were enrolled. Patients' cognitive function, verbal comprehension and memory were assessed before being enrolled. All groups initially underwent the standard informed consent process. Then the experimental groups received a second informed consent process with the aid of surgical planners, while the control group went through to a second round of standard informed consent. Questionnaires about appreciation, anxiety, and perceived and objective comprehension (on pathology, surgery, complications) were given.

Tridimensional surgical planners may be of great help in improving how technical information is conveyed to patients when consented for surgery. Considering that every individual has unique features, a standardised method cannot be taken into account, therefore, thanks to the case-specific 3D reconstruction of the patient's anatomy, the explanation of the surgical procedure can be customized for every patient. Using new 3D technologies is expected to reduce patients' anxiety and to improve the understanding of their conditions and the possible consequences related to any treatment options.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • having a cerebral tumor
  • no visual/auditory deficit
  • no psychiatric illness
  • italian mother-tongue

排除标准

  • younger than 18 or older than 70
  • pre-existing perceptual deficit and/or psychiatric illness
  • not italian mother-tongue

研究组 & 干预措施

Control

No Intervention

Patients receiving standard informed consent procedure before intervention

Planner 1

Experimental

Patients receiving 3D informed consent procedure before intervention with Surgical Theater

干预措施: 3D informed consent (Other)

Planner 2

Experimental

Patients receiving 3D informed consent procedure before intervention with Vesalius

干预措施: 3D informed consent (Other)

结局指标

主要结局

Evaluation of the comprehension of the benefits/risks of the intervention

时间窗: 1 year

Comprehension of the benefits/risks of the intervention evaluated through a ad hoc questionnaire

次要结局

  • Level of patient's anxiety(1 year)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eleonora Orena

Psychologist, Neuroscientist researcher

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

研究点 (2)

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