Initial Experience With a New Laparoscopic Based Robotically Assisted Surgical System for Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Operative Time
研究概览
简要总结
The Senhance™ surgical robotic system, previously known as Telelap Alf-X (TransEnterix, Morrisville, NC, USA) has recently become available in the UK. It aims to provide the robotic benefits of greater accuracy, dexterity and control with similar operational costs to traditional laparoscopy.
Patients randomly received either a standard laparoscopic cholecystectomy or the Senhance assisted cholecystectomy based on scheduled surgery date. A prospectively maintained database of the first 20 patients undergoing cholecystectomy with the Senhance Surgical System was retrospectively interrogated and compared to a concurrently treated group of 20 laparoscopically treated patients during the same timeframe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •ASA I or II Confirmed diagnosis of biliary colic or cholecystitis Normal LFTs
排除标准
- •Patients unable tor unwilling to consent BMI >40
研究组 & 干预措施
Senhance Cholecystectomy
Cholecystectomy operation performed using Senhance robotic system
干预措施: Senhance Assisted Cholecystectomy (Device)
Laparoscopic Cholecystectomy
Cholecystectomy operation performed using standard laparoscopic instruments
干预措施: Laparoscopic Cholecystectomy (Procedure)
结局指标
主要结局
Operative Time
时间窗: 1 day
次要结局
- Morbidity Data(30 days)
研究者
Ravi Aggarwal
Clinical Research Fellow
Imperial College London