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Recruiting NCT06451432
NCT06451432 The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
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| NCT ID | NCT06451432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Inguinal Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 464 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-09-30 |
Trial Parameters
Condition Inguinal Hernia
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Type INTERVENTIONAL
Phase N/A
Enrollment 464
Sex ALL
Min Age 0 Years
Max Age 16 Years
Start Date 2024-02-01
Completion 2027-09-30
Interventions
Percutaneous Inguinal Ring Suturing (PIRS) technique
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Brief 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 Criteria
Inclusion Criteria: 1\. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair Exclusion Criteria: 1. incarcerated inguinal hernia, which have to be operated immediately, 2. recurrent hernia 3. ventricular-peritoneal drain 4. non-descended testis 5. parents who are not able to understand the nature or consequences of the study.
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