Clinical trial NCT03623893: Hernia Exploration oR Not In Infants Analysis
Official title: A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Metachronous contralateral inguinal hernia
Hernia repair
Contralateral exploration
Cost-effectiveness
Infants
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2018-08-09
Enrollment: 416
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter randomized controlled trial.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of infants that undergo a second operation
timeFrame: One year after primary hernia repair
Secondary outcomes:
measure: Total duration of operation(s) including anaesthesia time and hospital admission(s)
timeFrame: One year after primary hernia repair
measure: Complications of anaesthesia and surgery
timeFrame: During hospital admission, four weeks and one year after primary hernia repair
measure: Health-related quality of life (HRQOL) of the operated infant
timeFrame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
measure: Parental distress and anxiety
timeFrame: At baseline before surgery, 4 weeks and one year after primary hernia repair and, if relevant, before and four weeks after re-operation
Other outcomes:
measure: Economic evaluation
timeFrame: Four weeks and one year after primary hernia repair and, if relevant, four weeks after re-operation
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, Vrije Universiteit Amsterdam
city: Amsterdam
country: Netherlands
facility: Emma Children's Hospital, Amsterdam UMC, University of Amsterdam
city: Den Haag
country: Netherlands
facility: Juliana Children's Hospital, HagaZiekenhuis
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus MC - Sophia Children's Hospital
city: Veldhoven
country: Netherlands
facility: Máxima Medical Center
Study officials:
References:
citation: Dreuning KMA, van Tulder MW, Been JV, Rovers MM, de Graaff JC, Stevens MF, Anema JR, Twisk JWR, van Heurn LWE, Derikx JPM; HERNIIA study group. Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial. Trials. 2021 Sep 30;22(1):670. doi: 10.1186/s13063-021-05606-w.