NCT00649142已完成不适用
Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 455
- 试验地点
- 2
- 主要终点
- Frequency of chronic pain
研究概览
简要总结
Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.
The current study will assess the above factors in a prospective study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years)
- •Primary unilateral groin hernia
- •Ability to use pain scales
排除标准
- •Neurological disease
- •Diabetes with late stage complications
研究组 & 干预措施
A
Active Comparator
Open sutured mesh repair
干预措施: Open sutured mesh repair (Procedure)
B
Active Comparator
Laparoscopic mesh glue fixation
干预措施: Laparoscopic mesh glue fixation (Procedure)
结局指标
主要结局
Frequency of chronic pain
时间窗: 6 months postoperatively
次要结局
- Changes in sensory function(6 months)
- Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors(6 months)
研究者
研究点 (2)
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