Off-site vs. On-site Simulation Training in Laparoscopy a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.
研究概览
简要总结
The study is a randomized study exploring the difference between off-site vs. on-site training in laparoscopic skills. The study will be performed using fifty surgical trainees from the departments of urology, surgery and gynecology. The participants will be recruited, enrolled and randomized during the introductory course in basic laparoscopic techniques held six times annually at Center of Clinical Education(CEKU).
Participants will be able to train laparoscopic skills on a Box Trainer(BT) and on a Virtual Reality Simulator(VRS). They will practice until they reach a predefined level of proficiency on seven basic modules, the procedure module; "salpingectomy" on the LapSim™ and reach the passing level of 358pts on the Training and Assessment of Basic Laparoscopic Techniques(TABLT) technical test.
The intervention group will have a portable trainer available to allow training at their convenience, be it at home or at work. The control group will only practice on-site at CEKU and at their local hospital.
Participants will be asked to keep a training log with details of time spend on training and number of training sessions. The training log will contain information on any type practice involving laparoscopy be it on a BT or a VRS at the local hospital, at home on the tablet trainer or training at CEKU. Also time spend in the operation room, assisting or performing laparoscopic surgery will be registered.
To pass the TABLT all participants will book a test session at CEKU for their final test at the end of their training. At the test sessions TABLT test scores will be established on site by the Chief Investigator and afterwards using video recordings of the test. A blinded rater will give scores based on the video recordings and this will be the decisive rating to determine whether the participant has passed the test.
To pass the VRS training an employee at CEKU will monitor a VRS practice session in which proficiency level is reached.
The enrollment of participants is expected to finish June 2015 a data analysis will be performed in July 2015.
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
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •hey have performed more than 50 laparoscopic procedures.
结局指标
主要结局
Difference in time(days) to reach a defined proficiency level(358pts) on the TABLT technical test.
时间窗: 6 months
Trainees use of off-site training in laparoscopic surgery
时间窗: 6 months
Qualitative focus group interviews, individual interviews and log-books
次要结局
- Difference in time(days) to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).(6 months)
- Difference in number of training sessions used to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).(6 months)
- Correlation between participants rating of pre-tests and a blinded rater(6 months)
- Difference in time(mins.) used on training to reach a defined proficiency level(358pts) on the TABLT technical test.(6 months)
- Difference in time(mins.) used on training to reach a defined proficiency level on seven basic tasks and the salpingectomy module on the Lap Sim(R).(6 months)
- Difference in the number of training sessions used to reach a defined proficiency level(358pts) on the TABLT technical test.(6 months)
研究者
Ebbe Thinggaard
Medical Doctor
Zealand University Hospital