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Hernia Exploration oR Not In Infants Analysis (HERNIIA)

A Randomized Controlled Trial to Study the Effectiveness and Cost-effectiveness of Contralateral Surgical Exploration During Unilateral Inguinal Hernia Repair in Children.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22121
Enrollment
378
Registered
2018-07-24
Start date
2019-04-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Inguinal hernia, Hernia repair, Contralateral exploration, Metachronous contralateral inguinal hernia, Cost-effectiveness, Infants Dutch: Liesbreuk, Liesbreukherstel, Contralaterale exploratie, Metachrone contralaterale liesbreuk, kosteneffectiviteit, zuigelingen

Interventions

Sponsors

VU University Medical Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Infants aged six months or younger with a primary unilateral inguinal hernia, undergoing open hernia repair

Exclusion criteria

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) - Parents who are not able to understand the nature or consequences of the study

Design outcomes

Primary

MeasureTime frame
1. Number of infants that undergo a second operation.

Secondary

MeasureTime frame
2. Total health care costs associated with each strategy. 3. Total number and duration of operation(s), anesthesia time and hospital admission(s). 4. Occurence of complications (wound infection, hematoma/hydrocele, testicular atrophy, apnea or recurrence) related to hernia repair. 5. Health-related quality of life (HRQOL) of the operated infants and their family.

Contacts

Public ContactKelly Dreuning

Department of Paediatric Surgery, Emma Children’s Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit, Amsterdam

k.m.dreuning@amc.uva.nl+31205661693

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)