Comparison of Dry-lab Laparoscopic Training and Robotic Virtual Simulator Training to Develop Basic Laparoscopic Skills: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- FLS score post-training session
研究概览
简要总结
The objective of the present study is to compare the effectiveness of dry-lab laparoscopic training and robotic simulator training among medical students without any prior laparoscopic experience.
详细描述
This study will be a randomized clinical trial conducted at the Swiss Foundation For Innovation And Training In Surgery (SFITS), which is part of the Geneva University Hospital in Switzerland. Recruitment of a sample of 100 medical students with no prior experience in laparoscopic surgery will be performed. The participants will be randomized in 2 groups (50 participants in each group). The study group will undergo a single session of training using a standard, dry-lab laparoscopic box. The control group will undergo a single session of training using the da Vinci Skills Simulator. Post-training surgical skills for both groups will be measured using exercises from the FLS manual skills assessment. The overall performance on the FLS test will be compared between the two groups .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical student at the University of Geneva
排除标准
- •Previous laparoscopic experience
- •Stereoblindness
结局指标
主要结局
FLS score post-training session
时间窗: Up to 1 hour after the beginning of the exam session.
This score is a composite outcome combining the time needed to finish the exercises and the proficiency in performing them (number of dropped objects, lack of movements precision, exercises rules violations, etc.). The score will go from 0 (worst score) to 800 (best score), with a passing score of 356.
次要结局
- Times needed to perform training exercises(Up to 1 hour after the beginning of the training session)
研究者
Pouya Iranmanesh
Principal Investigator
University Hospital, Geneva