Laparoscopic Fixation Free Obliteration of Inguinal Hernia Defect With the 3D Dynamic Responsive Implant ProFlor-E - Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility of inguinal hernia defect obliteration with ProFlor
研究概览
简要总结
This feasibility study highlights the features of the 3D dynamic responsive prosthesis ProFlor-E® for fixation free obliteration of inguinal hernia defect
详细描述
The 3D dynamic-responsive prosthesis for inguinal hernia repair ProFlor-E® recently introduced to the market has been laparoscopically employed for the repair of one recurrent inguinal hernia previously managed with anterior open approach. The scope of this feasibility study is to demonstrate that the positive effects of the 3D implant already proven in open inguinal hernia repair are also effective or even superior for the laparoscopic of recurrent/bilateral inguinal hernias compared to conventional treatment concept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients with recurrent inguinal hernia already repaired with open approach or suffering by bilateral inguinal hernias
排除标准
- •ASA >4 patients
研究组 & 干预措施
Inguinal hernia repair laparoscopic
recurrent inguinal hernia after open repair or bilateral hernia patients
干预措施: ProFlor laparoscopic technique (Device)
结局指标
主要结局
Feasibility of inguinal hernia defect obliteration with ProFlor
时间窗: intraoperative
Effectiveness of the laparoscopic procedure for inguinal hernia repair with ProFlor
次要结局
- Postoperative pain(from early stage until 18 months postop)
研究者
Giuseppe Amato
Consultant Professor
University of Cagliari