A Randomized Controlled Trial Comparing a Solo and Non-solo Approach for Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Operation time
研究概览
简要总结
To determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).
详细描述
Laporoscopic cholecystectomy usually requires three surgeons, including an operator, a camera assistant, and other instrument assistant. Recent advancement of technology made it possible to develop the conveniently adjustable holders for camera and other laparoscopic instruments. The application of these instruments enables "solo-surgery" wherein an operation is driven by single surgeon. During surgery, human assistant(s) are helpful because of their instant assistance according to the operation's need. Therefore, the utilization of instruments instead of human assistants would be cumbersome. However, the utilization of instruments would be helpful by enabling operation-driven repositioning of the camera and instrument(s). Currently, no attempt has been made to objectively compare the merits and demerits of these two procedures. Therefore, this study was conducted to determine the safety and feasibility of solo laparoscopic cholecystectomy, which is defined as the application of solo surgery to laparoscopic cholecystectomy, by comparing consecutive non-solo procedures conducted by a surgeon in the presence or absence of human assistant(s).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients planed to undergo elective laparoscopic cholecystectomy
- •Benign gallbladder diseases requiring surgery
- •The patients who are indicated for single-port laparoscopic cholecystectomy.
排除标准
- •the patients with complicated cholecystitis
- •the patients with the gallbladder with a thickness more than 4mm.
- •the patients who are expected to have severe peritoneal adhesion.
- •the patients with malignant gallbladder diseases.
- •the patients whose operation appears to need human assistant(s)
结局指标
主要结局
Operation time
时间窗: day 1
Operation time correlates with surgical difficulity.
次要结局
- Pain score(day 3)
研究者
Say-June Kim
Professor
Daejeon St. Mary's hospital