Comparing laparoscopic and open hernia repair in children
'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
NA · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06451432
This study is testing whether a new minimally invasive hernia repair technique for kids is better and cheaper than the traditional surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 464 (estimated) |
| Ages | 0 Years to 16 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 9 sites (Veldhoven, North Brabant and 8 other locations) |
| Trial ID | NCT06451432 on ClinicalTrials.gov |
What this trial studies
This study assesses the cost-effectiveness of laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) versus traditional open hernia repair for unilateral inguinal hernias in children aged 0-16 years. It aims to determine which technique is more effective in reducing the number of surgeries and associated healthcare costs while improving patient outcomes. The study will involve a multicenter randomized controlled trial design, comparing the two surgical approaches and measuring various outcome metrics, including complications and total surgery duration.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and children aged 0 to 16 years with a primary unilateral inguinal hernia.
Not a fit: Patients with incarcerated hernias, recurrent hernias, or other specific medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced healthcare costs for children undergoing inguinal hernia repair.
How similar studies have performed: Previous studies have shown promising results for laparoscopic techniques in hernia repair, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Veldhoven, North Brabant and 8 other locations
- Maxima Medisch Centrum — Veldhoven, North Brabant, Netherlands (RECRUITING)
- FlevoZiekenhuis — Almere, North Holland, Netherlands (RECRUITING)
- Amsterdam UMC, locatie AMC and VUmc — Amsterdam, North Holland, Netherlands (RECRUITING)
- Erasmus MC — Rotterdam, South Holland, Netherlands (NOT_YET_RECRUITING)
- MST — Enschede, Twente, Netherlands (NOT_YET_RECRUITING)
- Alrijne Ziekenhuis — Leiderdorp, Zuid-hHolland, Netherlands (NOT_YET_RECRUITING)
- UMCG — Groningen, Netherlands (NOT_YET_RECRUITING)
- Maastricht UMC+ — Maastricht, Netherlands (RECRUITING)
- Isala Ziekenhuis — Zwolle, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Joep Derikx, prof.dr. — Amsterdam UMC
- Study coordinator: Joep Derikx, prof.dr.
- Email: j.derixk@amsterdamumc.nl
- Phone: 020 - 566 8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inguinal Hernia, pediatric, PIRS, open inguinal hernia repair