Clinical trial NCT06451432: The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inguinal Hernia
Keywords: pediatric
PIRS
open inguinal hernia repair
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2024-06-11
Enrollment: 464
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing two study groups
Primary purpose: TREATMENT

Brief summary: 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.

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:

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.

Primary outcomes:
measure: Re-operation rate
timeFrame: within two years after the primary inguinal hernia repair
Secondary outcomes:
measure: Complications
timeFrame: Within two years after the primary inguinal hernia repair
measure: Duration of Surgery
timeFrame: Within two years after the primary inguinal hernia repair
measure: Post-operative pain
timeFrame: Within two years after the primary inguinal hernia repair
measure: Length of hospital stay
timeFrame: Within two years after the primary inguinal hernia repair
measure: Time to normal daily activities
timeFrame: Within two years after the primary inguinal hernia repair
measure: Cosmetic appearance
timeFrame: Within two years after the primary inguinal hernia repair
measure: Health-related quality of life
timeFrame: Within two years after the primary inguinal hernia repair
measure: Cost-effectiveness
timeFrame: Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair
Other outcomes:
Locations:
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
state: Brabant
city: Almere
country: Netherlands
facility: FlevoZiekenhuis
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC and VUmc
state: Noord-Holland
city: Enschede
country: Netherlands
facility: MST
state: Twente
city: Leiderdorp
country: Netherlands
facility: Alrijne Ziekenhuis
state: Zuid-hHolland
city: Rotterdam
country: Netherlands
facility: Erasmus MC
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: UMCG
city: Maastricht
country: Netherlands
facility: Maastricht UMC+
city: Zwolle
country: Netherlands
facility: Isala Ziekenhuis
Study officials:
affiliation: Amsterdam UMC
name: Joep Derikx, prof.dr.
role: PRINCIPAL_INVESTIGATOR
References: