NCT06451432

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
464

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Feb 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Feb 2024Sep 2028

Study Start

First participant enrolled

February 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 11, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

3.7 years

First QC Date

May 27, 2024

Last Update Submit

June 9, 2024

Conditions

Inguinal Hernia

Keywords

pediatricPIRSopen inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

  • Re-operation rate

    Number of re-operations related to primary inguinal hernia repair

    within two years after the primary inguinal hernia repair

Secondary Outcomes (8)

  • Complications

    Within two years after the primary inguinal hernia repair

  • Duration of Surgery

    Within two years after the primary inguinal hernia repair

  • Post-operative pain

    Within two years after the primary inguinal hernia repair

  • Length of hospital stay

    Within two years after the primary inguinal hernia repair

  • Time to normal daily activities

    Within two years after the primary inguinal hernia repair

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Percutaneous Inguinal Ring Suturing (PIRS) technique

Procedure: Percutaneous Inguinal Ring Suturing (PIRS) technique

Control group

NO INTERVENTION

Open inguinal hernia repair

Interventions

Percutaneous Inguinal Ring Suturing (PIRS) techniquePROCEDURE

Percutaneous Inguinal Ring Suturing (PIRS) technique

Intervention group

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair

You may not qualify if:

  • incarcerated inguinal hernia, which have to be operated immediately,
  • recurrent hernia
  • ventricular-peritoneal drain
  • non-descended testis
  • parents who are not able to understand the nature or consequences of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Maxima Medisch Centrum

Veldhoven, North Brabant, Netherlands

RECRUITING

FlevoZiekenhuis

Almere, North Holland, Netherlands

RECRUITING

Amsterdam UMC, locatie AMC and VUmc

Amsterdam, North Holland, 1105AZ, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, Netherlands

NOT YET RECRUITING

MST

Enschede, Twente, Netherlands

NOT YET RECRUITING

Alrijne Ziekenhuis

Leiderdorp, Zuid-hHolland, Netherlands

NOT YET RECRUITING

UMCG

Groningen, Netherlands

NOT YET RECRUITING

Maastricht UMC+

Maastricht, Netherlands

RECRUITING

Isala Ziekenhuis

Zwolle, Netherlands

RECRUITING

Related Publications (1)

  • Maat SC, de Vreeze LE, Eurlings R, Anema J, Van Baren R, Been JV, van den Broek F, Cakir H, van Dongen JM, Ferenschild F, de Graaf J, Nijveldt R, Ottenhof A, Ploeg AJ, Rippen H, Ruiterkamp J, Twisk JWR, Vermeulen E, De Wit R, Zijp G, van Heurn ELW, Derikx JPM. HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to study the (cost-)effectiveness of laparoscopic hernia repair compared to open hernia repair in children 0-16 years. BMJ Open. 2025 Dec 4;15(12):e110662. doi: 10.1136/bmjopen-2025-110662.

    PMID: 41344705DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Methods

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Joep Derikx, prof.dr.

    Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joep Derikx, prof.dr.

CONTACT

020 - 566 8000j.derixk@amsterdamumc.nl

Sanne Maat, MD. PhD

CONTACT

020 - 566 8000s.c.maat@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Due to the nature of the intervention (different type of scars), masking is not possible.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial comparing two study groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coördinating investigator

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 11, 2024

Study Start

February 1, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

June 11, 2024

Record last verified: 2024-06

Locations

NL(9)