Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 8
- 主要终点
- Cosmesis
研究概览
简要总结
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy
详细描述
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy.
- The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
- The secondary objective of this study is to assess the peri-operative clinical outcomes of robotic- assisted single incision cholecystectomy with da Vinci Single - Site Instruments™ in comparison to a multiport laparoscopic approach.
- The third objective of this study is to evaluate hernia incidence at 1 year and 18 months after surgery
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient between ages of 18- 80 year
- •Patient with symptomatic gallbladder disease
- •Patient willing to participate in this study and able to provide informed consent
排除标准
- •Patient pregnancy
- •Emergency patient
- •Patient with acute cholecystitis
- •Patient with upper midline visible abdominal scars or keloid
- •Presence of umbilical hernia , or prior umbilical hernia repair
- •Inability of patients to tolerate Trendelenberg position or pneumoperitoneum
- •Patient with cirrhosis
- •Patients with mental impairment that preclude giving informed consent
研究组 & 干预措施
Single-site robotic cholecystectomy
Single-site cholecystectomy using da Vinci robotic assisted surgery
干预措施: Cholecystectomy (Procedure)
Multi-port laparoscopic cholecystectomy
Multi-port cholecystectomy using laparoscopic surgery
干预措施: Cholecystectomy (Procedure)
结局指标
主要结局
Cosmesis
时间窗: up to 3 months after surgery
The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
次要结局
未报告次要终点