Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2026-01-04 @ 5:36 PM
Study NCT ID:
NCT06451432
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Due to the nature of the intervention (different type of scars), masking is not possible.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial comparing two study groups'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 464}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-09', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Re-operation rate', 'timeFrame': 'within two years after the primary inguinal hernia repair', 'description': 'Number of re-operations related to primary inguinal hernia repair'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': 'Surgical and anesthesiological complications'}, {'measure': 'Duration of Surgery', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': 'Total duration of surgery (including anaesthesia and total duration of operating room time)'}, {'measure': 'Post-operative pain', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': 'Postoperative pain is as medication requirement and VAS-score (1-9 score, 9 point scale, higher score equals more pain)'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': 'Number of days'}, {'measure': 'Time to normal daily activities', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': 'Number of days'}, {'measure': 'Cosmetic appearance', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': '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)'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Within two years after the primary inguinal hernia repair', 'description': '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.'}, {'measure': 'Cost-effectiveness', 'timeFrame': 'Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair', 'description': 'Cost-effectiveness is based of societal and healthcare costs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pediatric', 'PIRS', 'open inguinal hernia repair'], 'conditions': ['Inguinal Hernia']}, 'referencesModule': {'references': [{'pmid': '41344705', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nMain 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?\n\nHypothesis 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.\n\nStudy design Multicentre randomized controlled trial.\n\nStudy population Children aged 0 - 16 years with a unilateral inguinal hernia.\n\nIntervention Inguinal hernia repair with the laparoscopic PIRS technique.\n\nUsual care/comparison Inguinal hernia repair with the open technique.\n\nOutcome 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.\n\nSample 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair\n\nExclusion Criteria:\n\n1. incarcerated inguinal hernia, which have to be operated immediately,\n2. recurrent hernia\n3. ventricular-peritoneal drain\n4. non-descended testis\n5. parents who are not able to understand the nature or consequences of the study.'}, 'identificationModule': {'nctId': 'NCT06451432', 'acronym': 'HERNIIA-2', 'briefTitle': 'The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}, 'officialTitle': '\'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', 'orgStudyIdInfo': {'id': 'NL71765.029.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Percutaneous Inguinal Ring Suturing (PIRS) technique', 'interventionNames': ['Procedure: Percutaneous Inguinal Ring Suturing (PIRS) technique']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Open inguinal hernia repair'}], 'interventions': [{'name': 'Percutaneous Inguinal Ring Suturing (PIRS) technique', 'type': 'PROCEDURE', 'description': 'Percutaneous Inguinal Ring Suturing (PIRS) technique', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Veldhoven', 'state': 'North Brabant', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Frank van den Broek', 'role': 'CONTACT'}], 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'city': 'Almere', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Anne Ottenhof', 'role': 'CONTACT'}], 'facility': 'FlevoZiekenhuis'}, {'zip': '1105AZ', 'city': 'Amsterdam', 'state': 'North Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'J.P.M. Derikx, MD, PhD', 'role': 'CONTACT', 'email': 'j.derikx@amsterdamumc.nl', 'phone': '+31205665693'}, {'name': 'Jaap Oosterlaan, Prof.', 'role': 'CONTACT'}], 'facility': 'Amsterdam UMC, locatie AMC and VUmc', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Rotterdam', 'state': 'South Holland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hester Langeveld-Benders', 'role': 'CONTACT'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'Enschede', 'state': 'Twente', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Ralph de Wit', 'role': 'CONTACT'}], 'facility': 'MST', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Leiderdorp', 'state': 'Zuid-hHolland', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Arianne Ploeg', 'role': 'CONTACT'}], 'facility': 'Alrijne Ziekenhuis', 'geoPoint': {'lat': 52.15833, 'lon': 4.52917}}, {'city': 'Groningen', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Robertine van Baren', 'role': 'CONTACT'}], 'facility': 'UMCG', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Maastricht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Hamit Cakir', 'role': 'CONTACT'}], 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Zwolle', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Robert Nijveldt', 'role': 'CONTACT'}], 'facility': 'Isala Ziekenhuis', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'centralContacts': [{'name': 'Joep Derikx, prof.dr.', 'role': 'CONTACT', 'email': 'j.derixk@amsterdamumc.nl', 'phone': '020 - 566 8000'}, {'name': 'Sanne Maat, MD. PhD', 'role': 'CONTACT', 'email': 's.c.maat@amsterdamumc.nl', 'phone': '020 - 566 8000'}], 'overallOfficials': [{'name': 'Joep Derikx, prof.dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Amsterdam UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coördinating investigator', 'investigatorFullName': 'Sanne Maat', 'investigatorAffiliation': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)'}}}}