NCT Number: NCT03623893
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.
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All sexes
Interventional
Not applicable
Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
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.
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
Time frame: One year after primary hernia repair
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: During hospital admission, four weeks and one year after primary hernia repair
Occurence of wound infection, hematoma, hydrocele, testicular atrophy, apnoea or recurrence of inguinal hernia, related to hernia repair.
Time frame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
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, before and four weeks after re-operation
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.
Time frame: Four weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
Total health care costs associated with each strategy, assessed by a retrospective cost questionnaire and the iMTA Productivity Cost Questionnaire (iPCQ).
Amsterdam UMC, location VUmc
Other
A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
Acronym: HERNIIA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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