3 Versus 2 Dimensional HD Laparoscopy in Cholecystectomy: a Prospective, Single Blinded, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Duration of surgery
研究概览
简要总结
The 3D-systems have emerged also to the world of surgery, and the three-dimensional laparoscopic systems are gradually entering the operating rooms. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. Even though the 3D-systems have been widely studied in laboratory circumstances, there are still no evidence of benefits of 3D vs 2D in clinical point of view and no prospective randomized trials have been published. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system for cholecystectomy (LCC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for laparoscopic cholecystectomy
排除标准
- •Some other surgical operation planned during LCC
- •Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis, previous cholecystitis)
- •Operating surgeon experience less than 5 3D laparoscopy operations
研究组 & 干预措施
3D laparoscopic cholecystectomy
The normal laparoscopic cholecystectomy with three dimensional view
干预措施: 3D laparoscopic cholecystectomy (Procedure)
2D laparoscopic cholecystectomy
The normal laparoscopic cholecystectomy with two dimensional view
干预措施: 2D laparoscopic cholecystectomy (Procedure)
结局指标
主要结局
Duration of surgery
时间窗: Expected average time of surgery 1 hour
次要结局
- Intraoperative complications(During the operation, expected average time of surgery 1 hour)
- Complications, Clavien-Dindo classification(30 days after randomization)
- Postoperative stay in hospital(Expected range 0-7 day)
- Bleeding(During the operation, expected average time of surgery 1 hour)
- Mortality(30 days after randomization)
- Need for conversion into open surgery(During the operation, expected average time of surgery 1 hour)
- Total need of opioids in milligrams(Expected range 0-7 day)
- Operation theatre time(Expected average 1,5 hours)
- Number of participants with readmission(s)(30 days after randomization)
- Postoperative pain, VAS(Expected range 0-7 day)
研究者
Hanna Koppatz
MD
Helsinki University Central Hospital