Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy: A Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- Cost associated with performance of the procedure and post-operative care until discharge
研究概览
简要总结
This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.
详细描述
Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient recommended to undergo cholecystectomy
- •Patient age 18-80
- •Patient competent to give his/her own informed consent
- •Patient speaks English without the need for an interpreter
排除标准
- •Additional procedures planned during same surgery
- •Patient deemed inappropriate for TLC or SILS cholecystectomy
研究组 & 干预措施
Single-Incision Laparoscopic Cholecsytectomy (SILS)
干预措施: Single-Incision Laparoscopic Surgery cholecystectomy (Procedure)
Traditional Laparoscopic Cholecystectomy (TLC)
干预措施: Traditional Laparoscopic Cholecystectomy (TLC) (Procedure)
结局指标
主要结局
Cost associated with performance of the procedure and post-operative care until discharge
时间窗: 4 weeks
次要结局
- Pain scale reported by patient at discharge, 24 and 48 hours(24 hours and 48 hours)
- Amount of pain medicine required during 48 hours after surgery(48 hours)
- Major and minor gastrointestinal surgical complications, including conversion(4 weeks)
- Quality of Life(2 weeks and 4 weeks)