Three-dimensional High-definition (3DHD) Laparoscopy Versus Two-dimensional High-definition (2DHD) Laparoscopy in Cholecystectomy: a Clinical Controlled Randomized Double Blinded Trial.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of errors during the dissection of the Calot´s triangle
研究概览
简要总结
The aim of this study is to compare 3D-laparoscopy versus 2D-laparoscopy with the use of HD resolution in cholecystectomy in terms of error rating, performance time and subjective assessment.
详细描述
Conventional laparoscopy can be very challenging, especially with the requirement of converting the two-dimensional image of the operating field to a three-dimensional perception. This can potentially lead to a detrimental effect on the learning curve as well for the feasibility of the operation for the more inexperienced surgeon. In our hospital, the high frequency of cholecystectomy serves as a basis for the minimally experienced surgeons to explore whether three-dimensional laparoscopy provides a better ability for solving complex intraoperative tasks than the conventional laparoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for elective cholecystectomy (out-patient treatment)
排除标准
- •Previous upper abdominal surgery
- •ASA-score 3 or above
结局指标
主要结局
Number of errors during the dissection of the Calot´s triangle
时间窗: Expected duration: 20 minutes
The unedited videos of the operations will be assessed according to GERT (Generic Error Rating Tool) by three surgeons, blinded to which optical modalities is used during the operations as done in a previous pilot study.
次要结局
- Duration of the dissection of the Calot´s triangle(Expected duration: 20 minutes)
- Duration of surgery(Expected duration: 1 hour)
- The need for conversion to open surgery(intraoperative, expected duration of surgery: 1 hour)
- Estimated blood loss in ml(intraoperative, expected duration of surgery: 1 hour)
- Intraoperative complications(intraoperative, expected duration of surgery: 1 hour)
- Subjective assessment (Assessment of fatigue and perceived exertion)(an expected average of 15 minutes before and after the operation)
- Subjective assessment (optical modality and mental load assessment)(an expected average of 15 minutes after the operation)