Hernia Exploration oR Not In Infants Analysis

Overview

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.

Full Title of Study: “A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2022

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.

Interventions

  • Procedure: Contralateral exploration
    • 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.

Arms, Groups and Cohorts

  • Other: Intervention group
    • Unilateral inguinal hernia repair with contralateral exploration.
  • No Intervention: Control group
    • Unilateral inguinal hernia repair.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Total duration of operation(s) including anaesthesia time and hospital admission(s)
    • 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
  • Complications of anaesthesia and surgery
    • 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.
  • Health-related quality of life (HRQOL) of the operated infant
    • 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.
  • Parental distress and anxiety
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • VU University Medical Center
  • Collaborator
    • ZonMw: The Netherlands Organisation for Health Research and Development
  • Provider of Information About this Clinical Study
    • Principal Investigator: K.M.A. Dreuning, Coordinating Investigator HERNIIA trial – VU University Medical Center
  • Overall Contact(s)
    • Kelly Dreuning, MD, +31613438132, k.m.dreuning@amsterdamumc.nl

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