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临床试验/NCT05037383
NCT05037383已完成不适用

Motion and Viewing Analysis of Surgeons During Minimally Invasive Gynecological Interventions

prof. dr. Jan Deprest2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
Average number of people present in the operating room

研究概览

简要总结

During minimally invasive surgery (MIS), surgeons manipulate sharp and stiff instruments in the vicinity of fragile tissue, blood vessels, and critical nerves, where poor depth perception can have dramatic consequences. Since typically, 2-dimensional visualization is offered, to correctly infer the 3rd dimension, surgeons rely on their anatomical knowledge and experience. During unforeseen events, correct depth information can make the difference between success and failure. This explains the steep and long learning curve for surgeons. The absence of proper depth information slows down execution and leads to an unnecessary large mental load.

A recent document from the European Association of Endoscopic Surgery showed that 3D shortens operative time and learning curves and reduces complications. 'What the best way is to visualize 3D content' remains an open question. Near-to-eye displays provide small screens in front of each eye, while stereoscopic displays use glasses to project the 3D content to the eyes. The Da Vinci surgical system uses two individual optical panels. These systems are bulky, or restrict head movement, thus users have remarks on the ergonomics. The glasses for stereoscopic displays obscure the view, reduce brightness, and alter the color. Correct color is crucial to recognize tissue types and details or parts in shaded areas. Stereoscopic 3D displays lead to headache and eye-fatigue, called visually induced motion sickness in 11-22% of surgeons after several surgeries.

Autostereoscopic Visualization (ASV) is appealing for medical applications. Besides the improvement of depth perception, it allows 'glasses-free' operation. One of the key components of such displays is eye-tracking, that locates the eyes of the user to be able to render the 3D image to that viewpoint. ASV is a single-viewer application, which can be challenging in an operating room, with multiple people present. Therefore, a rigorous investigation is needed to maximize the performance of the algorithm and ensure the quality of service needed for medical use. It is crucial to collect data from real scenarios by recording the operation, the pose, motion of surgeons and the entire staff. These recordings will deliver solid understanding of the circumstances and rate of occurrences where eye-tracking and 3D visualization fails (or could fail). Furthermore, patterns can be recognized that could help to develop a robust eye-tracking algorithm and safety features for ASV.

详细描述

  1. Aim of the study

The aim of this study is to analyze the movement and direction of vision of the surgeon's eyes during gynecological interventions. The assessment is done by making video recordings of the medical staff during the procedure. The measured data consists of:

  • Position and movement of the medical personnel, and
  • Position and movement of the displays/screens being used, and
  • Light intensity during the surgical procedure A novel 3D visualization system is being developed to improve the safety of minimally invasive surgery. For this development, it is critical to understand current clinical practice during surgery. The videos recorded during this study will directly help to determine the design requirements for the development of the display.
  1. Medical condition or intervention under investigation

Gynecological laparoscopic interventions that involve suturing or extensive dissection, including hysterectomy, sacrocolpopexy and niche repair. 3. Study schedule

Eligible patients and involved staff members (i.e. surgeon, first assistant, nurse handling the instruments) will be informed on the purpose and nature of the trial. When consenting in written, intra-operative recordings will be carried out.

Since no patient data or follow-up on their condition is involved in the trial, the study ends for all involved at the end of the operation. 4. Equipment used during the trial

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients undergoing either sacrocolpopexy or hysterectomy or cesarean scar defect repair
  • For each operation to be eligible for the study, voluntary informed consent is required from all staff members involved

排除标准

  • Not given informed consent by patient or any of the staff member involved in the operation

结局指标

主要结局

Average number of people present in the operating room

时间窗: Duration of surgery

Number of people in the field of view of each camera at the same time. Visual assessment based on the recorded videos will be made.

Size and shape of the workspace (the space that is traveled) of the tracked people.

时间窗: Duration of surgery

Size of the workspace described in \[mm\] in x,y,z coordinates with respect to the cameras. This include average position and standard deviation in all three directions. The people being tracked are the surgeon, first assistant and the nurse handling the instrument. Tracking is done by placing visual markers on the head cap of the people that is being recorded by the cameras.

Distance of people from displays

时间窗: Duration of surgery

Distance of tracked people from the display they use in \[mm\]. Similarly as to workspace calculation, the distance will be calculated by means of video-based tracking of the people, using visual markers.

Direction of gaze of the tracked people

时间窗: Duration of surgery

Direction of gaze, i.e. direction where the person is looking, estimated based on head orientation. Head orientation is determined by using visual markers. Each visual marker has its own coordinate frame, from which the z axis determines where the marker is pointing. Since these will be placed on the head cap of the staff, the z axis of the marker will determine the direction of head orientation. Direction of gaze will be determined using a 3D vector \[x y z\] with origin of head position at each timestep.

次要结局

  • Movement of the display: Size and shape of the workspace of the displays.(Duration of the surgery)
  • Illumination levels throughout the intervention.(Duration of the surgery)

研究者

发起方
prof. dr. Jan Deprest
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

prof. dr. Jan Deprest

Clinical professor

Universitaire Ziekenhuizen KU Leuven

研究点 (2)

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