A Prospective Randomized Study to Evaluate the Clinical Impact of a Laparoscopic Radical Prostatectomy Online Simulator
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Operative time to perform the complete procedure
研究概览
简要总结
To evaluate the clinical impact of an online video simulator during the learning period of laparoscopic radical prostatectomy.
详细描述
Objectives: To compare two different approaches in learning laparoscopic radical prostatectomy , with or without using an online video simulator Design : Prospective randomized multicentric study
Methods: 20 surgeons considered as naive concerning their experience in laparoscopic radical prostatectomy will be randomized into two groups :1 group will use the online video simulator, 1 group will use usual learning methods except the online video simulator.
All procedures will be recorded from the beginning till the end.A video review will be preformed concerning all the videos in order to identify the total operative time and time to perform each one of the operative steps of the procedure.Clinical , biological and histological data will be collected in order to compare the two arms.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgeon beginning his clinical experience in laparoscopic radical prostatectomy and having performed less then 30 procedures before being enrolled in the study
- •Surgeon who intends to begin laparoscopic radical prostatectomy clinical practice
- •Surgeons who usually perform enough cases to enroll at least 10 patients during the study inclusion time
排除标准
- •Surgeon who does not have access to high speed internet (>1024 Ko/s)
- •Surgeons who do not intend to begin laparoscopic radical prostatectomy in his clinical practice
研究组 & 干预措施
1: without simulator
without simulator
干预措施: Laparoscopic Radical Prostatectomy (without a simulator) (Procedure)
2: with simulator
with simulator
干预措施: Laparoscopic Radical Prostatectomy (with a simulator) (Procedure)
结局指标
主要结局
Operative time to perform the complete procedure
时间窗: during the procedure
次要结局
- Operative time to complete each step of the procedure(each step of the procedure)
- Intraoperative bleeding(during the procedure)
- Conversion rate(during the procedure)
- Quantity of liquid obtained in drains(during the hospitalization)
- Duration of urethral stenting(during the hospitalization)
- Reintervention rate(during the patient participation)
- Duration of hospital stay(during the patient participation)
- Positive surgical margin(during the procedure)
- PSA value(at 3,6 and 12 months after the procedure)
- Continence rate(at 3, 6 and 12 months after surgery)
- Transfusion rate(Hospital stay)
- Complication rate(during the procedure)