NCT00788554已完成3 期
LEVEL Trial: Correction of Inguinal Hernia, Endoscopic Versus Lichtenstein. A Randomised Controlled Clinical Trial.
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 660
- 试验地点
- 1
- 主要终点
- hospital stay
研究概览
简要总结
The aim of this study is to compare laparoscopic total extraperitoneal and open mesh repair of inguinal hernia, with regard to hospital stay, postoperative pain, quality of life, postoperative recovery and return to daily activities, complications and recurrences
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed consent
- •age > 18 years
- •inguinal hernia(primary, recurrence or bilateral)
- •elective procedure
排除标准
- •Scrotal hernia
- •Prostatectomy, Pfannenstiehl-incision, pre-peritoneal surgery in history
- •Participation in other trial
- •Pregnancy
- •Communicative or cognitive restrictions
研究组 & 干预措施
1
Active Comparator
干预措施: Lichtenstein procedure (Procedure)
2
Active Comparator
干预措施: TEP (Procedure)
结局指标
主要结局
hospital stay
时间窗: 7 days
postoperative pain
时间窗: 6 weeks
return to work
时间窗: 6 weeks
quality of life
时间窗: 5 years
次要结局
- recurrence(5 years)
- total costs(1 month)
- operating time(1 day)
- operating costs(1 week)
- complication(1 month)
- mortality(5 years)
研究者
hasan eker
Prof. Dr. J.F. Lange
Erasmus Medical Center
研究点 (1)
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