Abstract
BackgroundThe incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5–30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely.MethodsThe Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants’ health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed.DiscussionThis study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia.Trial registrationClinicalTrials.govNCT03623893. Registered on August 9, 2018Netherlands Trial Register NL7194. Registered on July 24, 2018Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018
Highlights
Background and rationale {6a} Inguinal hernia is the most common paediatric surgical disorder with an incidence of 0.8–5% during childhood age and up to 30% in infants born preterm [1, 2]
Infants younger than 6 months old have the highest risk of developing metachronous contralateral inguinal hernia (MCIH) [3, 5,6,7]: the overall risk for MCIH in 49,568 children undergoing unilateral hernia repair from 61 studies was 5.8%
In infants who were younger than 6 months (n = 1470), the risk for MCIH development was substantially higher at 12.4% [4]
Summary
Background and rationale {6a} Inguinal hernia is the most common paediatric surgical disorder with an incidence of 0.8–5% during childhood age and up to 30% in infants born preterm [1, 2]. The processus vaginalis normally obliterates spontaneously before or shortly after birth If it remains patent, fluid, fat or intestines can move into the open inguinal canal and present as a clinically visible hernia. Surgical repair (i.e. closing the patent processus vaginalis (PPV)) is recommended shortly after diagnosis because of the risk of incarceration, which is reported to be 3–30% in the first 6 months of life and even higher if the infant was born preterm [3]. Infants younger than 6 months old have the highest risk of developing MCIH [3, 5,6,7]: the overall risk for MCIH in 49,568 children undergoing unilateral hernia repair from 61 studies was 5.8%. There is no consensus whether contralateral exploration should be performed routinely
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