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Open vs Laparoscopic hernia repair in children: A randomized controlled trial

Open vs Laparoscopic hernia repair in children: A randomized controlled trial - HERNIIA II trial: Hernia Endoscopic oR opeN repair In chIldren Analysis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56268
Enrollment
464
Registered
2020-08-21
Start date
2024-02-08
Completion date
Unknown
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

groin rupture inguinal hernia

Interventions

Open hernia repair or laparoscopic Percutaneous Internal Ring Sutering (PIRS) repair

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
No minimum to 15 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: infants aged 0 to 16 years of age with a primary unilateral inguinal hernia, undergoing hernia repair.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Children with 1. incarcerated inguinal hernia, which have to be operated urgently, 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.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Number of operations related to inguinal hernia within two year after inguinal hernia repair.

Secondary

MeasureTime frame
Duration of surgery, operative and postoperative complications, use of different anaesthetic techniques, duration of hospital admission, postoperative pain, time to full recovery, CPPV-rate, cosmetic appearance and cost-effectiveness (health care and social costs).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)