Comparing laparoscopic and open hernia repair in children
Official title: '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
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06451432 · Data updated 2026-11-12
This study is testing whether a new minimally invasive hernia repair technique for kids is better and cheaper than the traditional surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 0 Years to 16 Years |
| Sex | All |
| Enrollment | 464 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 9 sites (Veldhoven, North Brabant and 8 other locations) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | June 11, 2024 |
| Trial ID | NCT06451432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants and children aged 0 to 16 years with a primary unilateral inguinal hernia.
✕Probably not a fit
Patients with incarcerated hernias, recurrent hernias, or other specific medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results for laparoscopic techniques in hernia repair, suggesting potential success for this approach.
Who can join: the full rules
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 it's running
-
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 -
Maastricht UMC+
Maastricht, Netherlands Recruiting -
Isala Ziekenhuis
Zwolle, Netherlands Recruiting -
Erasmus MC
Rotterdam, South Holland, Netherlands Not yet recruiting
Show 3 more locations
-
Mst
Enschede, Twente, Netherlands Not yet recruiting -
Alrijne Ziekenhuis
Leiderdorp, Zuid-hHolland, Netherlands Not yet recruiting -
Umcg
Groningen, Netherlands Not yet 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Two laparoscopic techniques for repairing inguinal hernias in children
This study tests whether LPEC or LIS works better for repairing inguinal hernias in children aged 1 to 15 who need laparoscopic repair.
-
Shouldice groin hernia repair: permanent vs slowly dissolving stitches
We’re testing whether slowly dissolving stitches (PDS) work as well as permanent stitches (Prolene) for adults with a non-mesh Shouldice inguinal hernia repair.
-
Acupressure for Postoperative Pain After Laparoscopic TEP Hernia Repair
This trial tests whether true acupressure, given after surgery, reduces pain more than sham acupressure or standard care for adults undergoing laparoscopic TEP inguinal hernia repair.
-
TREPP: A Minimally Invasive Open Approach to Repair Inguinal Hernias
This study tests the trans rectus sheath extra-peritoneal procedure (TREPP) to repair inguinal hernias and see if it reduces pain and recurrence relative to traditional methods.
-
Camera-based non-contact vital sign monitoring during surgery
This project will try a camera-based non-contact system to measure heart rate, blood pressure, and oxygen levels in adults having surgery under general anesthesia.
-
Pneumoperitoneum time and bicarbonate changes during laparoscopic inguinal hernia repair
This study will see if longer pneumoperitoneum time during laparoscopic inguinal hernia repair causes changes in blood bicarbonate levels in adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.