Proficiency-based Versus Free Laparoscopic Training in Cholecystectomy Using the Simbionix LAP Mentor™. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Time to extract the gall bladder.
研究概览
简要总结
Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.
详细描述
Virtual reality simulators are widely accepted tools to familiarize surgical novices with the principles of laparoscopy without jeopardizing patient safety. However, access to a Virtual reality simulator and initial instruction alone followed by free training of the surgical novice may not be sufficient to achieve the training goals efficiently. The aims of this study are to determine if proficiency based laparoscopic training on the Simbionx LAP Mentor™ with external formative assessment using peer group derived benchmarks is superior to free training with self-assessment using the simulated laparoscopic cholecystectomy procedure with different endpoints (time to extract the gallbladder, serious complications, safe cautery and instrument pathways) as outcome parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Surgical novices (trainees / residents)
- •Performed less than five laparoscopic procedures
- •No previous simulator experience
排除标准
- •Specialist surgeons
- •Performed more than five laparoscopic procedures
- •Previous experience with a simulator
研究组 & 干预措施
Free training
干预措施: Laparsocopic cholecystectomy (Procedure)
Proficiency-based training
干预措施: Laparsocopic cholecystectomy (Procedure)
结局指标
主要结局
Time to extract the gall bladder.
时间窗: 10 minutes in average
The time to extract the gall bladder on a virtual simulator is typically 10 minutes. However this varies according to the settings of the difficulty chosen on the virtual reality software. This is a continuous variable measuring the duration for a trainee surgeon to extract the gall bladder (measured in seconds). The start point is the beginning of the exercise and the finishing point is once the gall bladder is completely resected (gall bladder mobilized and the cystic duct and artery dissected and ligated).
次要结局
- Total path length of right instrument(10 minutes in average)
- Safe cautery(10 minutes in average)
- Serious intra-operative complications(10 minutes in average)