Development, Intraoperative Demonstration and Visualization of Surgical Assistance Functions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of intraoperative technical errors of the applied assistance system
研究概览
简要总结
The aim of the planned study is the development of surgical assistance functions on the basis of clinical routine data and the evaluation of the technical feasibility of an intraoperative demonstration and visualization of such assistance functions in visceral surgery. Furthermore, this trial aims to provide preliminary data on the clinical outcome of such assistance systems.
详细描述
The aim of the clinical trial is to create the conditions for the comprehensive scientific use of new technologies such as augmented and virtual reality, computer-aided navigation and robotics in surgery in order to use these technologies in the future for improved surgical therapy for the benefit of the patient and to support the treating surgical team. The IDEMONSTRATE study is divided into two study parts: the development of a surgical assistance function based on routinely collected clinical (image) data that displays the position of anatomical structures (e.g. blood vessels, organs, tumors) in real time and the technical evaluation of this assistance system in the clinical environment.
For the development of the surgical assistance function, data routinely collected as part of surgical inpatient treatment will be used. For research purposes (and explicitly not to prepare for approval as a medical device), a surgical assistance function is to be developed from this that displays the position of anatomical structures in real time during visceral surgical interventions. This system will then be evaluated in the second part of the study with regard to its technical feasibility and medical relevance.
For the evaluation of the developed assistance function in the context of clinical treatment, the patients and the staff involved will be informed separately. All patients who are eligible for inclusion in the evaluating part of the study are fully capable of giving their consent. All doctors who will take part in the evaluation of the developed algorithm in a clinical context are specialists in general or visceral surgery; these doctors are informed in detail about the risks and sources of error in the context of the application before the developed algorithm and the associated assistance function is used. The evaluation of the developed assistance function takes place exclusively in the context of planned interventions, not in emergency situations.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for surgery using a laparoscopic or open surgical camera, a surgical robot (e.g., DaVinci system), or an intraoperative imaging modality (e.g. sonography, intraoperative CT)
- •Patient understands German
排除标准
- •Lack of ability to consent
结局指标
主要结局
Incidence of intraoperative technical errors of the applied assistance system
时间窗: during surgery
Major technical errors: system crash, calculation latency \> 1 second, Image distortions
次要结局
- Assessment of usability of guidance system(48 hours after surgery)
- Evaluation of surgical skills(during surgery)
- Kind of peri-operative morbidity after resection(At day of discharge, assessed up to 90 days)
- Duration of postoperative intermediate/intensive care unit stay [days](At day of discharge, assessed up to 90 days)
- Display accuracy of guidance functions(during surgery)
- Operating time [min](during surgery)
- Duration of postoperative hospital stay [days](At day of discharge, assessed up to 90 days)
- Frequency of peri-operative morbidity after resection(At day of discharge, assessed up to 90 days)