Comparison of Hernia Sac Ligation Versus Invagination in Lichtenstein Tension Free Mesh Hernioplasty. Does Type of Hernia Have a Role on Outcomes?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- postoperative pain levels
研究概览
简要总结
Management of indirect hernial sac in inguinal hernia repairs has long been a subject of debate among general surgeons. Although hernial sac high ligation (HL) is a time-honored concept in groin hernia surgery, non-ligation/invagination is gaining more popularity. The aim of this study is to compare the effects of hernia sac ligation and invagination in patients with Lichtenstein mesh hernioplasty (LMH). Also, investigators aimed to investigate the possible association between the hernial defect size and postoperative early pain in both groups.
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
- Double (Participant, Care Provider)
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
- •unilateral uncomplicated indirect hernia
- •elective operations
- •spinal anesthesia
排除标准
- •Bilateral hernias
- •recurrent cases
- •femoral-scrotal hernias
- •those who refused to give consent
- •those who were given general anesthesia besides spinal anesthesia
- •those who were repaired with a method other than Lichtenstein mesh hernioplasty
结局指标
主要结局
postoperative pain levels
时间窗: postoperative period before discharge-1 year after discharge
10-point Visual Analogue Scale (VAS)
次要结局
- recurrence(postoperative 1 year)
- postoperative complications(postoperative period before discharge (mainly the first 24 hours))
- perioperative outcomes(postoperative period before discharge (mainly the first 24 hours))
研究者
Ahmet Burak Ciftci
Principal Investigator
Samsun Education and Research Hospital