Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- long-term post operative pain
研究概览
简要总结
The purpose of this study is to compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Unilateral inguinal hernia
- •suitable for open mesh repair in local anesthesia as well as laparoscopic repair
- •ASA score I-III
- •informed consent
排除标准
- •ASA score IV (not suitable for TEP)
- •bilateral hernias (laparoscopic repair preferable)
- •recurrent hernia (primary repair affects preferable treatment)
- •large scrotal hernias (not suitable for local anesthesia)
- •earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)
研究组 & 干预措施
Lichtenstein in local anesthesia (LLA)
Patient operated in local anesthesia, with an anterior mesh repair according to Lichtenstein
干预措施: Mesh repair for primary inguinal hernia (Procedure)
TEP
Patient receives a totally extraperitoneal laparoscopic repair
干预措施: Mesh repair for primary inguinal hernia (Procedure)
结局指标
主要结局
long-term post operative pain
时间窗: 6 wks, 1 year
次要结局
- cost-effectiveness of the separate procedures(6wks, 1year)
研究者
Ursula Dahlstrand
MD, PhD
Uppsala University Hospital