Hernia Exploration oR Not In Infants Analysis
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 768
Summary
- Conditions
- Inguinal Hernia
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Multicenter randomized controlled trial.Masking: Double (Investigator, Outcomes Assessor)Masking Description: Participants and care providers are aware of allocation; masking is impossible because of the nature of the intervention.Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 6 years
- Gender
- Both males and females
Description
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 r...
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.
Tracking Information
- NCT #
- NCT03623893
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Investigators
- Not Provided