The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Percutaneous Inguinal Ring Suturing (PIRS) technique.
- Who it may be relevant to
- Registry conditions: Inguinal Hernia. Basic parameters: 0 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed description
Research question Inguinal hernia repair is one of the most common operations in children. After open unilateral inguinal hernia repair, 6-8% of patients develops an inguinal hernia on the contralateral side. Laparoscopic inguinal hernia offers the opportunity to inspect the contralateral groin and repair an asymptomatic contralateral hernia, if present.
Main question: What is the most (cost-)effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years: the open or laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique?
Hypothesis The optimal treatment for children with an inguinal hernia is laparoscopic hernia repair, since the surgeon can inspect and possibly, repair, the contralateral groin. Laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia, less hospital admissions, lower costs and a better quality of life compared to open inguinal hernia repair.
Study design Multicentre randomized controlled trial.
Study population Children aged 0 - 16 years with a unilateral inguinal hernia.
Intervention Inguinal hernia repair with the laparoscopic PIRS technique.
Usual care/comparison Inguinal hernia repair with the open technique.
Outcome Measures Primary: Number of operations related to inguinal hernia repair and cost-effectiveness (social and healthcare related costs). Secondary: complications, total duration of surgery (including anaesthesia and total duration of operating room time), post-operative pain, length of hospital stay, time to normal daily activities, cosmetic appearance, health-related quality of life. All outcome measures will be assessed within two years after the primary inguinal hernia correction.
Sample size/data analysis 464 patients (power of 0.80, alpha 0.05). Cost-effectiveness analysis/budget impact analysis The economic evaluation will be assessed from a societal and health care perspective. Cost-effectiveness will be assessed in terms of QALYs and the primary and secondary outcomes. A budget impact analysis will be conducted using the "Budget Impact Analyse - leidraad en rekentool" of ZonMw. Missing data will be imputed.
Interventions
- Procedure Percutaneous Inguinal Ring Suturing (PIRS) technique
Percutaneous Inguinal Ring Suturing (PIRS) technique
Primary outcome measures
- Re-operation rate [Time frame: within two years after the primary inguinal hernia repair]
Secondary outcome measures (8)
- Complications [Time frame: Within two years after the primary inguinal hernia repair]
- Duration of Surgery [Time frame: Within two years after the primary inguinal hernia repair]
- Post-operative pain [Time frame: Within two years after the primary inguinal hernia repair]
- Length of hospital stay [Time frame: Within two years after the primary inguinal hernia repair]
- Time to normal daily activities [Time frame: Within two years after the primary inguinal hernia repair]
- Cosmetic appearance [Time frame: Within two years after the primary inguinal hernia repair]
- Health-related quality of life [Time frame: Within two years after the primary inguinal hernia repair]
- Cost-effectiveness [Time frame: Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 9 centers
- Maxima Medisch Centrum — Veldhoven
- FlevoZiekenhuis — Almere
- Amsterdam UMC, locatie AMC and VUmc — Amsterdam
- Erasmus MC — Rotterdam
- MST — Enschede
- Alrijne Ziekenhuis — Leiderdorp
- UMCG — Groningen
- Maastricht UMC+ — Maastricht
- … and 1 more center
Publications
- Maat SC, de Vreeze LE, Eurlings R, Anema J, Van Baren R, Been JV, van den Broek F, Cakir H, van Dongen JM, Ferenschild F, C de Graaff J, Nijveldt R, Ottenhof A, Ploeg AJ, Rippen H, Ruiterkamp J, Twisk JWR, Vermeulen E, De Wit R, Zijp G, van Heurn ELW, Derikx JPM. HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to stu PMID 41344705
Identifiers
NCT: NCT06451432 · NL71765.029.20