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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | Percutaneous Inguinal Ring Suturing (PIRS) technique |
|
| Control group | No Intervention | Open inguinal hernia repair |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Inguinal Ring Suturing (PIRS) technique | Procedure | Percutaneous Inguinal Ring Suturing (PIRS) technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Re-operation rate | Number of re-operations related to primary inguinal hernia repair | within two years after the primary inguinal hernia repair |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Surgical and anesthesiological complications | Within two years after the primary inguinal hernia repair |
| Duration of Surgery | Total duration of surgery (including anaesthesia and total duration of operating room time) |
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Inclusion Criteria:
1. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joep Derikx, prof.dr. | Contact | 020 - 566 8000 | j.derixk@amsterdamumc.nl | |
| Sanne Maat, MD. PhD | Contact | 020 - 566 8000 | s.c.maat@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Joep Derikx, prof.dr. | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxima Medisch Centrum | Recruiting | Veldhoven | North Brabant | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41344705 | Derived | 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 study the (cost-)effectiveness of laparoscopic hernia repair compared to open hernia repair in children 0-16 years. BMJ Open. 2025 Dec 4;15(12):e110662. doi: 10.1136/bmjopen-2025-110662. |
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Randomized controlled trial comparing two study groups
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Due to the nature of the intervention (different type of scars), masking is not possible.
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| Within two years after the primary inguinal hernia repair |
| Post-operative pain | Postoperative pain is as medication requirement and VAS-score (1-9 score, 9 point scale, higher score equals more pain) | Within two years after the primary inguinal hernia repair |
| Length of hospital stay | Number of days | Within two years after the primary inguinal hernia repair |
| Time to normal daily activities | Number of days | Within two years after the primary inguinal hernia repair |
| Cosmetic appearance | Cosmetic appearance is scored by parents and a member of a research team using a 5-Likert scale (scale 1-5, higher score equals a better outcome) | Within two years after the primary inguinal hernia repair |
| Health-related quality of life | Health related quality of life will be measured using the EQ-5D version (EQ-5D-5L) four weeks, one year, and two years after primary surgery. A higher score equals a better outcome. | Within two years after the primary inguinal hernia repair |
| Cost-effectiveness | Cost-effectiveness is based of societal and healthcare costs. | Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair |
| FlevoZiekenhuis | Recruiting | Almere | North Holland | Netherlands |
|
| Amsterdam UMC, locatie AMC and VUmc | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
|
| Erasmus MC | Not yet recruiting | Rotterdam | South Holland | Netherlands |
|
| MST | Not yet recruiting | Enschede | Twente | Netherlands |
|
| Alrijne Ziekenhuis | Not yet recruiting | Leiderdorp | Zuid-hHolland | Netherlands |
|
| UMCG | Not yet recruiting | Groningen | Netherlands |
|
| Maastricht UMC+ | Recruiting | Maastricht | Netherlands |
|
| Isala Ziekenhuis | Recruiting | Zwolle | Netherlands |
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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