NCT04623580招募中不适用
Flemish Inguinal and Femoral Hernia Prospective Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- Chronic pain after inguinal hernia repair
研究概览
简要总结
Prospective registry. The purpose of this clinical trial will be to measure surgical outcome parameters (e.g. recurrence, chronic pain and other quality indicators) after inguinal hernia repair using Patient Reported Outcome Measures (PROMs) in the short- and long-term.
详细描述
The primary objective is to investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.
The secondary objectives are:
- Surgical Site Occurrence (SSO) after 30 days
- Scope and incidence of pre- and postoperative pain (NRS 0 to 10)
- The difference between pre- and postoperative NRS scores (relative NRS score)
- Presence of pain and impact of pain on daily life activities
- Satisfaction and quality of life
- Sexual function
- Anxiety and depression
- Catastrophizing
- Recurrence
- Development of a predictive model for chronic pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Chronic pain after inguinal hernia repair
时间窗: 5 years
To investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.
次要结局
未报告次要终点
研究者
研究点 (2)
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