Hernia Exploration oR Not In Infants Analysis (HERNIIA)
Recruiting
- Conditions
- Inguinal hernia, Hernia repair, Contralateral exploration, Metachronous contralateral inguinal hernia, Cost-effectiveness, InfantsDutch: Liesbreuk, Liesbreukherstel, Contralaterale exploratie, Metachrone contralaterale liesbreuk, kosteneffectiviteit, zuigelingen
- Registration Number
- NL-OMON22121
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 378
Inclusion Criteria
Infants aged six months or younger with a primary unilateral inguinal hernia, undergoing open hernia repair
Exclusion Criteria
- Children with 1. incarcerated inguinal hernia, who have to be operated urgently, 2. ventricular-peritoneal drain, 3. non-descended testis
- Patients who receive bilateral inguinal hernia repair because of increased operation risks (e.g. poor pulmonary condition)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of infants that undergo a second operation.
- Secondary Outcome Measures
Name Time Method 2. Total health care costs associated with each strategy.<br /><br>3. Total number and duration of operation(s), anesthesia time and hospital admission(s).<br /><br>4. Occurence of complications (wound infection, hematoma/hydrocele, testicular atrophy, apnea or recurrence) related to hernia repair.<br /><br>5. Health-related quality of life (HRQOL) of the operated infants and their family.<br />