Contribution of 3D Printing in Anatomical Lung Segmentectomies: a Prospective Randomized Controlled Pilot Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Surgeon's mental workload.
研究概览
简要总结
The aim of the present work was to evaluate if the presence on the operating field of a 3D printed personalized model of the pulmonary anatomy of a patient operated by full thoracoscopy for an anatomical segmentectomy, makes it possible to reduce the mental workload and the fatigue of the surgeon.
详细描述
Between 28.10.2020 and 05.10.2021, we successively included all anatomic segmentectomies performed by full thoracoscopy in our department, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.
We performed a prospective randomized controlled pilot trial on 2 parallel arms:
- The "Digital" arm
- The "Digital+Object" arm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all anatomic segmentectomies performed by full thoracoscopy, except for S6 segmentectomies, S4+5 left bisegmentectomy and patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.
排除标准
- •S6 segmentectomies
- •S4+5 left bisegmentectomy
- •Patients for whom the time to surgery was considered too short to obtain the 3D printed model before surgery.
结局指标
主要结局
Surgeon's mental workload.
时间窗: 1 day
measure of mental workload by the NASA-TLX score at the end of the surgery: It is a multidimensional rating scale that has six bipolar dimensions: mental demand (MD); physical demand (PD); time demand (TD); self performance (P); effort (E); and frustration (F). The dimensions thus reflect tasks (DM, PD, TD), performance (P), and behavioral factors (E and F). NASA-TLX is calculated through a self-questionnaire, using 20-point visual analogue scales anchored by very low and very high. The test provides a global load score between zero and 100 and by sub-dimensions, higher scores indicating higher mental loads of subjective perceptions.
次要结局
- Duration of the surgical procedure(1 day)
- The surgeon's stress during surgery(1 day)
- The surgeon's overall satisfaction at the end of the surgery.(1 day)
- Surgeon's attention to work by d2-R test(1 day)
- Surgeon's attention to work by EncephalApp Stroop test.(1 day)