Inguinal Hernia
Conditions
Keywords
pediatric, PIRS, open inguinal hernia repair
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.
Interventions
PROCEDUREPercutaneous Inguinal Ring Suturing (PIRS) technique
Percutaneous Inguinal Ring Suturing (PIRS) technique
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention (different type of scars), masking is not possible.
Intervention model description
Randomized controlled trial comparing two study groups
Eligibility
Sex/Gender
ALL
Age
0 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Re-operation rate | within two years after the primary inguinal hernia repair | Number of re-operations related to primary inguinal hernia repair |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Surgery | Within two years after the primary inguinal hernia repair | Total duration of surgery (including anaesthesia and total duration of operating room time) |
| Post-operative pain | Within two years after the primary inguinal hernia repair | Postoperative pain is as medication requirement and VAS-score (1-9 score, 9 point scale, higher score equals more pain) |
| Length of hospital stay | Within two years after the primary inguinal hernia repair | Number of days |
| Complications | Within two years after the primary inguinal hernia repair | Surgical and anesthesiological complications |
| Cosmetic appearance | Within two years after the primary inguinal hernia repair | 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) |
| Health-related quality of life | Within two years after the primary inguinal hernia repair | 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. |
| Cost-effectiveness | Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair | Cost-effectiveness is based of societal and healthcare costs. |
| Time to normal daily activities | Within two years after the primary inguinal hernia repair | Number of days |
Countries
Netherlands
Contacts
Primary ContactJoep Derikx, prof.dr.
Backup ContactSanne Maat, MD. PhD
Outcome results
None listed