The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair

Not Applicable

Recruiting

• Conditions: Inguinal Hernia
• Interventions: Procedure: Percutaneous Inguinal Ring Suturing (PIRS) technique

• Registration Number: NCT06451432
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-05-27
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-09
• Last Update Submitted: 2024-06-09
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Primary Completion: 2027-09-30
• Study Completion: 2028-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 464

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Percutaneous Inguinal Ring Suturing (PIRS) technique	Percutaneous Inguinal Ring Suturing (PIRS) technique

Primary Outcome Measures

Name	Time	Method
Re-operation rate	within two years after the primary inguinal hernia repair	Number of re-operations related to primary inguinal hernia repair

Secondary Outcome Measures

Name	Time	Method
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)
Complications	Within two years after the primary inguinal hernia repair	Surgical and anesthesiological complications
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)
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)
Cost-effectiveness	Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair	Cost-effectiveness is based of societal and healthcare costs.
Length of hospital stay	Within two years after the primary inguinal hernia repair	Number of days
Time to normal daily activities	Within two years after the primary inguinal hernia repair	Number of days
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.

Trial Locations

Locations (9)

MST; 🇳🇱 Enschede, Twente, Netherlands

Alrijne Ziekenhuis; 🇳🇱 Leiderdorp, Zuid-hHolland, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands

FlevoZiekenhuis; 🇳🇱 Almere, Noord-Holland, Netherlands

Amsterdam UMC, locatie AMC and VUmc; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Isala Ziekenhuis; 🇳🇱 Zwolle, Netherlands

Maxima Medisch Centrum; 🇳🇱 Veldhoven, Brabant, Netherlands

UMCG; 🇳🇱 Groningen, Netherlands

Maastricht UMC+; 🇳🇱 Maastricht, Netherlands