Utilizing 3D Printed Personalized Aortic Lesion Models to Assist Surgeons in Preoperative Assessment and Planning of Aortic Aneurysm Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- surgical time
研究概览
简要总结
Using 3D printing technology to create personalized models of diseased heart and aortic blood vessels, surgeons can perform preoperative planning and evaluate relevant indicators.
详细描述
Background: Previous systematic reviews have indicated that approximately 82% of surgeries using 3D printed lesion models for preoperative planning have shown better surgical outcomes, and about half of the surgeries have demonstrated reduced operative time. In recent years, there have been numerous studies focusing on the application of 3D printing technology in aortic aneurysms. This study aims to employ 3D printing technology to fabricate personalized aortic blood vessel models with lesions.
Study Design: A single-centre, pilot study.
Methods: This study is a single-center, prospective clinical trial. The study plans to enroll 10 participants in the experimental group, and collect data from another 10 participants as the historical control group. The historical control group data will be matched-paired based on gender, age, and surgical type in sequential order.
Effect: We anticipate that through the use of 3D printed lesion models, we can reduce surgical time, decrease surgery-related complications, and enhance the smoothness of surgical team preparation for the procedure. Additionally, this approach can provide patients with a better understanding of their own condition and the upcoming surgical intervention.
Key words: 3D printing; pre-operative planning; thoracic aorta aneurysm; abdominal aorta aneurysm
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with thoracic or abdominal aortic aneurysm
- •Signed surgical consent
- •Non-emergent surgery
- •Had 2D CT imaging within the last 6 months
排除标准
- •Refusal to use lesion images for model creation
- •Refusal to participate in the study
研究组 & 干预措施
historical control group
conventional preoperative assessment
干预措施: historical control (Other)
3D printed lesion model group
using 3D printed lesion models for preoperative planning
干预措施: 3D printed lesion model (Other)
结局指标
主要结局
surgical time
时间窗: immediately after the surgical procedure
the duration of the surgical procedure
次要结局
未报告次要终点
研究者
Ke-Yun, Chao
Group leader of Respiratory Therapists
Fu Jen Catholic University
