The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair (HERNIIA-2)

June 9, 2024 updated by: Sanne Maat, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

'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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

464

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
      • Groningen, Netherlands
        • Not yet recruiting
        • UMCG
        • Contact:
          • Robertine van Baren
      • Maastricht, Netherlands
        • Recruiting
        • Maastricht UMC+
        • Contact:
          • Hamit Cakir
      • Zwolle, Netherlands
        • Recruiting
        • Isala Ziekenhuis
        • Contact:
          • Robert Nijveldt
    • Brabant
      • Veldhoven, Brabant, Netherlands
        • Recruiting
        • Maxima Medisch Centrum
        • Contact:
          • Frank van den Broek
    • Noord-Holland
      • Almere, Noord-Holland, Netherlands
        • Recruiting
        • Flevoziekenhuis
        • Contact:
          • Anne Ottenhof
      • Amsterdam, Noord-Holland, Netherlands, 1105AZ
        • Recruiting
        • Amsterdam UMC, locatie AMC and VUmc
        • Contact:
        • Contact:
          • Jaap Oosterlaan, Prof.
    • Twente
      • Enschede, Twente, Netherlands
        • Not yet recruiting
        • MST
        • Contact:
          • Ralph de Wit
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands
        • Not yet recruiting
        • Erasmus MC
        • Contact:
          • Hester Langeveld-Benders
    • Zuid-hHolland
      • Leiderdorp, Zuid-hHolland, Netherlands
        • Not yet recruiting
        • Alrijne Ziekenhuis
        • Contact:
          • Arianne Ploeg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Percutaneous Inguinal Ring Suturing (PIRS) technique
Procedure: Percutaneous Inguinal Ring Suturing (PIRS) technique
Percutaneous Inguinal Ring Suturing (PIRS) technique
No Intervention: Control group
Open inguinal hernia repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Re-operation rate
Time Frame: within two years after the primary inguinal hernia repair
Number of re-operations related to primary inguinal hernia repair
within two years after the primary inguinal hernia repair

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: Within two years after the primary inguinal hernia repair
Surgical and anesthesiological complications
Within two years after the primary inguinal hernia repair
Duration of Surgery
Time Frame: Within two years after the primary inguinal hernia repair
Total duration of surgery (including anaesthesia and total duration of operating room time)
Within two years after the primary inguinal hernia repair
Post-operative pain
Time Frame: 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)
Within two years after the primary inguinal hernia repair
Length of hospital stay
Time Frame: Within two years after the primary inguinal hernia repair
Number of days
Within two years after the primary inguinal hernia repair
Time to normal daily activities
Time Frame: Within two years after the primary inguinal hernia repair
Number of days
Within two years after the primary inguinal hernia repair
Cosmetic appearance
Time Frame: 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)
Within two years after the primary inguinal hernia repair
Health-related quality of life
Time Frame: 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.
Within two years after the primary inguinal hernia repair
Cost-effectiveness
Time Frame: Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair
Cost-effectiveness is based of societal and healthcare costs.
Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Joep Derikx, prof.dr., Amsterdam UMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2028

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 9, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL71765.029.20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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