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).

Completed

Conditions: groin rupture
Inguinal hernia
10027664
10043413

Registration Number: NL-OMON50346

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 340

Inclusion Criteria

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Number of operations related to inguinal hernia within one year after inguinal<br /><br>hernia repair.</p><br>

Secondary Outcome Measures

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