RecruitingNot ApplicableNCT06451432

The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair

'Hernia Endoscopic oR opeN Repair In chIldren Analysis": A Randomized Controlled Trial to Study the (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Enrollment

464 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Inguinal Hernia

Summary

This study assess the (cost-)effectiveness of open versus laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique for unilateral inguinal hernia repair in children aged 0-16 years.

Eligibility

Min Age: 0 YearsMax Age: 16 Years

Inclusion Criteria1

\. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair

Exclusion Criteria5

incarcerated inguinal hernia, which have to be operated immediately,
recurrent hernia
ventricular-peritoneal drain
non-descended testis
parents who are not able to understand the nature or consequences of the study.

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Interventions

PROCEDUREPercutaneous Inguinal Ring Suturing (PIRS) technique

Percutaneous Inguinal Ring Suturing (PIRS) technique

Locations(9)

Maxima Medisch Centrum

Veldhoven, North Brabant, Netherlands

FlevoZiekenhuis

Almere, North Holland, Netherlands

Amsterdam UMC, locatie AMC and VUmc

Amsterdam, North Holland, Netherlands

Erasmus MC

Rotterdam, South Holland, Netherlands

MST

Enschede, Twente, Netherlands

Alrijne Ziekenhuis

Leiderdorp, Zuid-hHolland, Netherlands

UMCG

Groningen, Netherlands

Maastricht UMC+

Maastricht, Netherlands

Isala Ziekenhuis

Zwolle, Netherlands

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NCT06451432

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