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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06451432
Other study ID # NL71765.029.20
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date September 30, 2028

Study information

Verified date June 2024
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Joep Derikx, prof.dr.
Phone 020 - 566 8000
Email j.derixk@amsterdamumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 464
Est. completion date September 30, 2028
Est. primary completion date September 30, 2027
Accepts healthy volunteers No
Gender All
Age group 0 Years to 16 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Percutaneous Inguinal Ring Suturing (PIRS) technique
Percutaneous Inguinal Ring Suturing (PIRS) technique

Locations

Country Name City State
Netherlands FlevoZiekenhuis Almere Noord-Holland
Netherlands Amsterdam UMC, locatie AMC and VUmc Amsterdam Noord-Holland
Netherlands MST Enschede Twente
Netherlands UMCG Groningen
Netherlands Alrijne Ziekenhuis Leiderdorp Zuid-hHolland
Netherlands Maastricht UMC+ Maastricht
Netherlands Erasmus MC Rotterdam Zuid-Holland
Netherlands Maxima Medisch Centrum Veldhoven Brabant
Netherlands Isala Ziekenhuis Zwolle

Sponsors (1)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Re-operation rate Number of re-operations related to primary inguinal hernia repair within two years after the primary inguinal hernia repair
Secondary Complications Surgical and anesthesiological complications Within two years after the primary inguinal hernia repair
Secondary Duration of Surgery Total duration of surgery (including anaesthesia and total duration of operating room time) Within two years after the primary inguinal hernia repair
Secondary 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
Secondary Length of hospital stay Number of days Within two years after the primary inguinal hernia repair
Secondary Time to normal daily activities Number of days Within two years after the primary inguinal hernia repair
Secondary 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
Secondary 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
Secondary Cost-effectiveness Cost-effectiveness is based of societal and healthcare costs. Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair
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