NCT00492804已完成2 期
Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of postoperative pain
研究概览
简要总结
Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.
It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.
This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Uni- or bilateral inguinal hernia
- •Karnofsky-index ≥70
- •Informed consent
排除标准
- •Recurrent inguinal hernia
- •Previous inguinal operation
- •Emergent operation
- •Severe comorbidities
研究组 & 干预措施
Neurectomy
Other
干预措施: Lichtenstein hernia repair (Procedure)
Neurectomy
Other
干预措施: Neurectomy (Procedure)
Nerve preservation
Other
干预措施: Lichtenstein hernia repair (Procedure)
结局指标
主要结局
Incidence of postoperative pain
时间窗: up to three years
次要结局
- Incidence of hypesthesia or paraesthesia(one and three years)
- Recurrence rate(one and three years)
- Rate of intra- and postoperative complications(one and three years)
- Quality of life(one and three years)
研究者
研究点 (1)
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