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…
ID
Bron
Verkorte titel
Aandoening
Inguinal hernia, Hernia repair, Contralateral exploration, Metachronous contralateral inguinal hernia, Cost-effectiveness, Infants
Dutch: Liesbreuk, Liesbreukherstel, Contralaterale exploratie, Metachrone contralaterale liesbreuk, kosteneffectiviteit, zuigelingen
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Number of infants that undergo a second operation.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
T1: Baseline
T2: Four weeks after primary hernia repair
T3: One year after primary hernia repair
Onderzoeksproduct en/of interventie
Contralateral exploration
Publiek
Kelly Dreuning
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31205661693
k.m.dreuning@amc.uva.nl
Wetenschappelijk
Kelly Dreuning
P.O. Box 22660
Amsterdam 1100 DD
The Netherlands
+31205661693
k.m.dreuning@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Infants aged six months or younger with a primary unilateral inguinal hernia, undergoing open hernia repair
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7194 |
| NTR-old | NTR7384 |
| Ander register | 852001903 : 2017.596 |