Laparoscopic Versus Robot-assisted Ventral Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
Randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.
详细描述
Ventral hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •surgeon determined need for ventral hernia repair
排除标准
- •<18 & >99 years of age
- •Medical indication for open repair
研究组 & 干预措施
laparoscopic ventral hernia
laparoscopic ventral hernia repair
干预措施: laparoscopic repair (Procedure)
robot-assisted ventral hernia
robot-assisted ventral hernia repair
干预措施: robot-assisted repair (Procedure)
结局指标
主要结局
Operative time
时间窗: perioperative time
time from start to finish of procedure, procedure start and stop times as recorded by anesthesia
次要结局
- Post operative pain score(until year five post-operative)
