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ID
Source
Brief title
Health condition
Inguinal hernia, Hernia repair, Contralateral exploration, Metachronous contralateral inguinal hernia, Cost-effectiveness, Infants
Dutch: Liesbreuk, Liesbreukherstel, Contralaterale exploratie, Metachrone contralaterale liesbreuk, kosteneffectiviteit, zuigelingen
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Number of infants that undergo a second operation.
Secondary outcome
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.
Background 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 solely unilateral inguinal hernia repair will be performed.
Study objective
Contralateral exploration during unilateral inguinal hernia repair in children younger than six months reduces the incidence of
contralateral inguinal hernia and decreases the number and total duration of operations, anesthesia time and hospital admissions and is associated with reduced health-care costs, less complications and better quality of life compared to no exploration.
Study design
T1: Baseline
T2: Four weeks after primary hernia repair
T3: One year after primary hernia repair
Intervention
Contralateral exploration
Kelly Dreuning
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31205661693
k.m.dreuning@amc.uva.nl
Kelly Dreuning
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31205661693
k.m.dreuning@amc.uva.nl
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)
- Parents who are not able to understand the nature or consequences of the study
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL7194 |
| NTR-old | NTR7384 |
| Other | 852001903 : 2017.596 |