'Hernia Endoscopic oR opeN Repair In chIldren Analysis": A Randomized Controlled Trial to Study the (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 464
- 试验地点
- 10
- 主要终点
- Re-operation rate
研究概览
简要总结
This study assess the (cost-)effectiveness of open versus laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique for unilateral inguinal hernia repair in children aged 0-16 years.
详细描述
Research question Inguinal hernia repair is one of the most common operations in children. After open unilateral inguinal hernia repair, 6-8% of patients develops an inguinal hernia on the contralateral side. Laparoscopic inguinal hernia offers the opportunity to inspect the contralateral groin and repair an asymptomatic contralateral hernia, if present.
Main question: What is the most (cost-)effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years: the open or laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique?
Hypothesis The optimal treatment for children with an inguinal hernia is laparoscopic hernia repair, since the surgeon can inspect and possibly, repair, the contralateral groin. Laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia, less hospital admissions, lower costs and a better quality of life compared to open inguinal hernia repair.
Study design Multicentre randomized controlled trial.
Study population Children aged 0 - 16 years with a unilateral inguinal hernia.
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
盲法说明
Due to the nature of the intervention (different type of scars), masking is not possible.
入排标准
- 年龄范围
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair
排除标准
- •incarcerated inguinal hernia, which have to be operated immediately,
- •recurrent hernia
- •ventricular-peritoneal drain
- •non-descended testis
- •parents who are not able to understand the nature or consequences of the study.
结局指标
主要结局
Re-operation rate
时间窗: within two years after the primary inguinal hernia repair
Number of re-operations related to primary inguinal hernia repair
次要结局
- Post-operative pain(Within two years after the primary inguinal hernia repair)
- Complications(Within two years after the primary inguinal hernia repair)
- Duration of Surgery(Within two years after the primary inguinal hernia repair)
- Cosmetic appearance(Within two years after the primary inguinal hernia repair)
- Cost-effectiveness(Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair)
- Length of hospital stay(Within two years after the primary inguinal hernia repair)
- Time to normal daily activities(Within two years after the primary inguinal hernia repair)
- Health-related quality of life(Within two years after the primary inguinal hernia repair)
研究者
Sanne Maat
Coördinating investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)