A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 416
- 试验地点
- 7
- 主要终点
- Proportion of infants that undergo a second operation
研究概览
简要总结
This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than six months with a unilateral inguinal hernia. In half of the participants contralateral exploration will be performed, while in the other half only unilateral inguinal hernia repair will be performed.
详细描述
There is a high incidence of metachronous (i.e. a second) contralateral inguinal hernia (MCIH) in infants with an inguinal hernia (5-30%, most studies report 10%), with the highest risk in infants aged less than 6 months. Metachronous hernia is associated with the risk of incarceration and general risks and costs of a second operation. This can potentially be avoided by contralateral exploration at the first operation. On the other hand contralateral exploration may turn out to be unnecessary, is associated with additional operating time and cost, and may be associated with additional complications of surgery (including testicular atrophy, wound infection) and anesthesia. Both policies to routinely explore the contralateral side or not are used in the treatment of unilateral inguinal hernias in children. There is no high-grade level of evidence of the superiority of one of either policy.
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 (Investigator, Outcomes Assessor)
盲法说明
Participants and care providers are aware of allocation; masking is impossible because of the nature of the intervention.
入排标准
- 年龄范围
- — 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants aged younger than six months at first presentation with a primary unilateral inguinal hernia undergoing open hernia repair are considered eligible for inclusion.
排除标准
- •Infants with (1) incarcerated inguinal hernia requiring urgent surgery, (2) a ventricular-peritoneal drain, (3) non-descended testis.
研究组 & 干预措施
Intervention group
Unilateral inguinal hernia repair with contralateral exploration.
干预措施: Contralateral exploration (Procedure)
Control group
Unilateral inguinal hernia repair.
结局指标
主要结局
Proportion of infants that undergo a second operation
时间窗: One year after primary hernia repair
The number of infants that undergo a second operation related to unilateral inguinal hernia within one year after primary inguinal hernia repair
次要结局
- Total duration of operation(s) including anaesthesia time and hospital admission(s)(One year after primary hernia repair)
- Complications of anaesthesia and surgery(During hospital admission, four weeks and one year after primary hernia repair)
- Parental distress and anxiety(At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, before and four weeks after re-operation)
- Health-related quality of life (HRQOL) of the operated infant(At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation)
研究者
K.M.A. Dreuning
Coordinating Investigator HERNIIA trial
Amsterdam UMC, location VUmc