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

Inguinal Hernia Clinical Trial

— HERNIIA-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451432
• Other study ID #: NL71765.029.20
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

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