Single Incision Laparoscopic Cholecystectomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety and feasibility
研究概览
简要总结
The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.
The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
详细描述
Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.
In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults male and female(>18 years old)
- •Capable of giving informed consent
- •Ultrasound proven cholelithiasis
- •Symptomatic cholelithiasis
- •Elective cholecystectomy
排除标准
- •Pregnancy
- •Contraindications for general anesthesia
- •Morbid obesity
- •Multiple previous abdominal surgeries
- •Uncontrolled medical conditions
- •Acute cholecystitis
结局指标
主要结局
Safety and feasibility
时间窗: 12 months
次要结局
- Short-term clinical outcomes(12 months)