Single Incision Versus Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Operative Time
研究概览
简要总结
Prospective randomized trial of single incision versus standard 4 port laparoscopic cholecystectomy. Hypothesis is that the operative time will be longer with single incision.
详细描述
This will be a prospective, randomized clinical trial involving patients who present to the hospital with an indication for cholecystectomy. We will offer enrollment to several institutions provided they receive institutional approval.
This will be a definitive trial design. Based on our operative times with SILS compared with our recent experience in standard laparoscopy, a sample size of 60 patients will give us a power of 0.8 with an α of 0.05.
After the procedure, both groups will be managed in the same manner per routine care. They will be discharged when tolerating a regular diet and their pain is well-controlled on oral pain medication.
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
- None
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Need for cholecystectomy
排除标准
- •Need for cholangiogram
结局指标
主要结局
Operative Time
时间窗: 1 day
次要结局
- Operative complications(2 weeks)
- length of hospitalization(1 week)
- doses of analgesics(1 week)
- hospital/operation charges(1 week)
- surgeon perception of difficulty(1 day)
- cosmetic scores(6 months)
研究者
Shawn St. Peter
MD
Children's Mercy Hospital Kansas City