A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 416
- Locations
- 7
- Primary Endpoint
- Proportion of infants that undergo a second operation
Study Overview
Brief Summary
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.
Detailed 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- 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.
Eligibility Criteria
- Ages
- — to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants aged younger than six months at first presentation with a primary unilateral inguinal hernia undergoing open hernia repair are considered eligible for inclusion.
Exclusion Criteria
- •Infants with (1) incarcerated inguinal hernia requiring urgent surgery, (2) a ventricular-peritoneal drain, (3) non-descended testis.
Arms & Interventions
Intervention group
Unilateral inguinal hernia repair with contralateral exploration.
Intervention: Contralateral exploration (Procedure)
Control group
Unilateral inguinal hernia repair.
Outcomes
Primary Outcomes
Proportion of infants that undergo a second operation
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
K.M.A. Dreuning
Coordinating Investigator HERNIIA trial
Amsterdam UMC, location VUmc