Effect of Virtual Endoscopy Simulator Training on Real Patient Endoscopy: A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Patient satisfaction measured on a visual analogue scale (VAS)
研究概览
简要总结
Trainees (Residents in internal medicine), naive to real patient endoscopy, will be randomized to receive either 3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator GI-Mentor or no training before starting on-patient endoscopy in the University of Vienna Medical School Endoscopy Unit. Patients satisfaction and pain, technical accuracy and number of found/missed pathologies as well as average time for successful endoscopy will be recorded. After one month or 50 supervised, self performed endoscopies, trainees will be evaluated again with the above mentioned criteria during ten consecutive investigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trainees: naive to real patient endoscopy before training phase
排除标准
- •Medical doctors with experience in gastrointestinal endoscopy
- •Patients sedated for upper GI endoscopy
- •Patients unwilling or unable to sign informed consent
研究组 & 干预措施
1: Training
3 weeks/2 hours per day of structured training for a total of 20 hours on the virtual endoscopy simulator
干预措施: Simulator Training (Procedure)
2: No Training
No simulator training before starting endoscopy training on real patients
结局指标
主要结局
Patient satisfaction measured on a visual analogue scale (VAS)
时间窗: once immediately after patient endoscopy
次要结局
- pain during endoscopy, measured with patient documentation on a visual analogue scale (VAS)(once immediately after patient endoscopy)
- technical accuracy (oral introduction of the scope into the esophagus, ability of passing the endoscope through the pylorus, inversion of the scope in the gastric fundus)(during endoscopy)
- number of found/missed pathologies(during endoscopy)
- average time for successful endoscopy(during endoscopy)