A Randomized Controlled Study of Self Fixating Mesh Versus Non Fixating Polyester Mesh for Laparoscopic Inguinal Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 285
- 试验地点
- 1
- 主要终点
- Chronic postoperative pain
研究概览
简要总结
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
详细描述
This is a randomized, blinded comparison of self-gripping mesh and standard polyester mesh for laparoscopic, primary inguinal hernia repair performed in a Totally ExtraPeritoneal (TEP) fashion.
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
- Single (Participant)
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
- •> 18 years
- •ASA Classification I, II, III
- •scheduled for elective TEP inguinal hernia repair
排除标准
- •ASA Classification IV or greater
- •needing emergency surgery
- •known history of narcotic dependence
- •undergoing bilateral inguinal or combined umbilical hernia repair
- •undergoing other procedures during same anesthetic
- •undergoing recurrent inguinal hernia repair
研究组 & 干预措施
Self-Fixating Hernia Mesh
Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
干预措施: Use of self-fixating mesh for inguinal hernia repair (Procedure)
Self-Fixating Hernia Mesh
Self-fixating polyester mesh will be used for laparoscopic inguinal hernia repair.
干预措施: Absorbable tacks may be used in hernias >2cm (Procedure)
Non-Fixating Hernia Mesh
Non-fixating polyester mesh will be used for laparoscopic hernia repair.
干预措施: Use of non-fixating mesh for inguinal hernia repair (Procedure)
结局指标
主要结局
Chronic postoperative pain
时间窗: 1 year
次要结局
- Incidence of hernia recurrence(1 year)