A randomized controlled trial to study the necessity and cost-effectiveness of contralateral surgical exploration during inguinal hernia repair in children. Hernia Exploration oR Not In Infants Analysis (HERNIIA).

A randomized controlled trial to study the necessity and cost-effectiveness of contralateral surgical exploration during inguinal hernia repair in children. Hernia Exploration oR Not In Infants Analysis (HERNIIA). - HERNIIA-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50346

Enrollment

340

Registered

2018-07-03

Start date

2019-04-17

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

groin rupture Inguinal hernia

Interventions

Contralateral exploration or no contralateral exploration in chrildren with unilateral inguinal hernia repair.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Infants aged 6 months or younger Primary unilateral inguinal hernia Undergoing open hernia repair

Exclusion criteria

Exclusion criteria: Incarcerated inguinal hernia in need for an emergency operation Ventricular-peritoneal drain Non-descended testis Parents who are not able to understand the nature or consequences of the study

Design outcomes

Primary

Measure	Time frame
Number of operations related to inguinal hernia within one year after inguinal hernia repair.	—

Secondary

Measure	Time frame
Length of hospital stay related to inguinal hernia; Complications of surgery (testicular atrophy, wound infection, apnoea, recurrence); Total duration of operations (including anaesthesia) related to inguinal hernia repair; Direct and indirect costs related to inguinal hernia repair within one year after surgery; Health-related Quality of Life of the operated infants and parents/caretakers.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)