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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
416
Surgery eventually performed when a patent processus vaginalis or hernia exists on the other side than the side on which the child has to be operated on, will be exactly the same as the inguinal hernia repair on the 'symptomatic' side. Exploration of the contralateral side will increase anaesthesia time by 10-15 minutes.
Amsterdam UMC, Vrije Universiteit Amsterdam
Amsterdam, Netherlands
Emma Children's Hospital, Amsterdam UMC, University of Amsterdam
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Proportion of infants that undergo a second operation
The number of infants that undergo a second operation related to unilateral inguinal hernia within one year after primary inguinal hernia repair
Time frame: One year after primary hernia repair
Total duration of operation(s) including anaesthesia time and hospital admission(s)
Total duration of operation(s) including anaesthesia time and total duration of hospital admission(s) related to inguinal hernia within one year after primary repair
Time frame: One year after primary hernia repair
Complications of anaesthesia and surgery
Occurence of wound infection, hematoma, hydrocele, testicular atrophy, apnoea or recurrence of inguinal hernia, related to hernia repair.
Time frame: During hospital admission, four weeks and one year after primary hernia repair
Health-related quality of life (HRQOL) of the operated infant
HRQOL of the operated infants is measured by the TAPQOL (TNO-AZL Preschool Children Quality of Life), a parent-reported questionnaire that is clustered into 12 multi-item scales, with higher scores (range 0-100) indicating better HRQOL.
Time frame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
Parental distress and anxiety
Parental distress and anxiety of the families of the operated infants is measured by 1) State-Trait Anxiety Inventory (STAI), used as an indicator of parental distress, and 2) Distress Thermometer for Parents (DT-P), a well-validated, brief screening instrument that is frequently used in clinical practice in the Netherlands as a quick screener to identify distress and everyday problems in parents of children who need medical treatment.
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Erasmus MC - Sophia Children's Hospital
Rotterdam, Netherlands
Juliana Children's Hospital, HagaZiekenhuis
The Hague, Netherlands
Máxima Medical Center
Veldhoven, Netherlands
Time frame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, before and four weeks after re-operation