Hernia Exploration oR Not In Infants Analysis
- Conditions
- Inguinal Hernia
- Interventions
- Procedure: Contralateral exploration
- Registration Number
- NCT03623893
- Lead Sponsor
- Amsterdam UMC, location VUmc
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 416
Infants aged younger than six months at first presentation with a primary unilateral inguinal hernia undergoing open hernia repair are considered eligible for inclusion.
Infants with (1) incarcerated inguinal hernia requiring urgent surgery, (2) a ventricular-peritoneal drain, (3) non-descended testis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group Contralateral exploration Unilateral inguinal hernia repair with contralateral exploration.
- Primary Outcome Measures
Name Time Method Proportion of infants that undergo a second operation 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 Outcome Measures
Name Time Method Total duration of operation(s) including anaesthesia time and hospital admission(s) 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 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.
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 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.
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 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.
Trial Locations
- Locations (7)
Erasmus MC - Sophia Children's Hospital
🇳🇱Rotterdam, Netherlands
Máxima Medical Center
🇳🇱Veldhoven, Netherlands
Emma Children's Hospital, Amsterdam UMC, University of Amsterdam
🇳🇱Amsterdam, Netherlands
Amsterdam UMC, Vrije Universiteit Amsterdam
🇳🇱Amsterdam, Netherlands
Juliana Children's Hospital, HagaZiekenhuis
🇳🇱Den Haag, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands