Randomized Clinical Trial of Lichtenstein Patch or Prolene Hernia System for Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Long-term Sequelae
研究概览
简要总结
This randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by Gilbert (Prolene Hernia System®) or an onlay mesh applied according to Lichtenstein.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uni- or bilateral
- •Primary or recurrent
排除标准
- •body-mass index over 40kg/m2, severe co-morbidities
研究组 & 干预措施
Prolene Hernia System device
Inguinal hernia repair either with a bilayer mesh (PHS)
干预措施: Open mesh inguinal hernia repair (Procedure)
Prolene Hernia System device
Inguinal hernia repair either with a bilayer mesh (PHS)
干预措施: Prolene Hernia System (Device)
Lichtenstein
Inguinal hernia repair with the Lichtenstein technique
干预措施: Open mesh inguinal hernia repair (Procedure)
Lichtenstein
Inguinal hernia repair with the Lichtenstein technique
干预措施: Lichtenstein technique (Procedure)
结局指标
主要结局
Long-term Sequelae
时间窗: 5 years
Any pain at five years
次要结局
未报告次要终点
研究者
Jaana Vironen
Consultant
Helsinki University Central Hospital