Inguinal HerniaHERNIIA-2NCT06451432
The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
A study testing Percutaneous Inguinal Ring Suturing (PIRS) technique in people with Inguinal Hernia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Percutaneous Inguinal Ring Suturing (PIRS) technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 464 participants
- Where
- 9 sitesNetherlands
- Study dates
- 1 Feb 2024to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Netherlands9 sites, 9 recruiting
- Recruiting
FlevoZiekenhuis
Almere, North Holland
Anne Ottenhof
- Recruiting
Amsterdam UMC, locatie AMC and VUmc
Amsterdam, North Holland, 1105AZ
J.P.M. Derikx, MD, PhD, +31205665693, j.derikx@amsterdamumc.nl
Jaap Oosterlaan, Prof.
- Not yet recruiting
MST
Enschede, Twente
Ralph de Wit
- Not yet recruiting
UMCG
Groningen
Robertine van Baren
- Not yet recruiting
Alrijne Ziekenhuis
Leiderdorp, Zuid-hHolland
Arianne Ploeg
- Recruiting
Maastricht UMC+
Maastricht
Hamit Cakir
- Not yet recruiting
Erasmus MC
Rotterdam, South Holland
Hester Langeveld-Benders
- Recruiting
Maxima Medisch Centrum
Veldhoven, North Brabant
Frank van den Broek
- Recruiting
Isala Ziekenhuis
Zwolle
Robert Nijveldt
About this study
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
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Percutaneous Inguinal Ring Suturing (PIRS) technique
- Keywords
- pediatric, PIRS, open inguinal hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Inguinal Ring Suturing (PIRS) techniqueProcedure or surgery
Percutaneous Inguinal Ring Suturing (PIRS) technique
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Percutaneous Inguinal Ring Suturing (PIRS) technique Receives: Procedure: Percutaneous Inguinal Ring Suturing (PIRS) technique |
| Control group | No intervention | Open inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-operation rate
Number of re-operations related to primary inguinal hernia repair
Measured: within two years after the primary inguinal hernia repair
Secondary outcomes (8)
Complications
Surgical and anesthesiological complications
Measured: Within two years after the primary inguinal hernia repair
Duration of Surgery
Total duration of surgery (including anaesthesia and total duration of operating room time)
Measured: Within two years after the primary inguinal hernia repair
Post-operative pain
Postoperative pain is as medication requirement and VAS-score (1-9 score, 9 point scale, higher score equals more pain)
Measured: Within two years after the primary inguinal hernia repair
Length of hospital stay
Number of days
Measured: Within two years after the primary inguinal hernia repair
Time to normal daily activities
Number of days
Measured: Within two years after the primary inguinal hernia repair
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)
Measured: Within two years after the primary inguinal hernia repair
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.
Measured: Within two years after the primary inguinal hernia repair
Cost-effectiveness
Cost-effectiveness is based of societal and healthcare costs.
Measured: Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Feb 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial comparing two study groups
- Masking
- None (open label)
- Enrolment
- 464 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanne Maat, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Joep Derikx, prof.dr., Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451432
- Sponsor's protocol ID
- NL71765.029.20
- Acronym
- HERNIIA-2
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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, C de Graaff 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.
PubMed 41344705
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06451432
- Acronym / sponsor ID
- HERNIIA-2 / NL71765.029.20
- Conditions
- Inguinal Hernia
- Keywords
- pediatric, PIRS, open inguinal hernia repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 464 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial comparing two study groups
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Procedure: Percutaneous Inguinal Ring Suturing (PIRS) techniquePercutaneous Inguinal Ring Suturing (PIRS) technique |
| Control group | No intervention | –Open inguinal hernia repair |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Inguinal Ring Suturing (PIRS) techniquePercutaneous Inguinal Ring Suturing (PIRS) technique | Procedure or surgery | Intervention group |
Primary outcome
Re-operation rate
Time frame: within two years after the primary inguinal hernia repair
Number of re-operations related to primary inguinal hernia repair
8 secondary outcomes
Complications
Time frame: Within two years after the primary inguinal hernia repair
Duration of Surgery
Time frame: Within two years after the primary inguinal hernia repair
Post-operative pain
Time frame: Within two years after the primary inguinal hernia repair
Length of hospital stay
Time frame: 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
Cosmetic appearance
Time frame: 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
Cost-effectiveness
Time frame: Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 41344705Maat SC, de Vreeze LE, Eurlings R, Anema J, Van Baren R, Been JV, van den Broek F, Cakir H, van Dongen JM, Ferenschild F, C de Graaff 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joep Derikx, prof.dr. principal investigator
Amsterdam UMC
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Inguinal Ring Suturing (PIRS) technique in people with Inguinal Hernia, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 9 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joep Derikx, prof.dr. (020 - 566 8000, j.derixk@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-operation rate (time frame: within two years after the primary inguinal hernia repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.