{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T13:08:30Z","timestamp":1771247310131,"version":"3.50.1"},"reference-count":24,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T00:00:00Z","timestamp":1764806400000},"content-version":"unspecified","delay-in-days":3,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"Netherlands Organization for Health Research and Development","doi-asserted-by":"crossref","award":["10390022210026"],"award-info":[{"award-number":["10390022210026"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,10,14]]},"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Inguinal hernia repair is one of the most frequently performed operations in the paediatric population and can be performed according to two approaches: open or laparoscopic. At present, decisive evidence about the best treatment strategy is lacking and consequently, there is an ongoing debate about the most (cost-)effective treatment for the paediatric inguinal hernia. The aim of the Hernia Endoscopic oR opeN repair In chIldren Analysis\u2014trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0\u201316 years with a primary unilateral inguinal hernia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A national multicentre randomised controlled trial will be performed including 464 children aged 0\u201316 years with a primary unilateral inguinal hernia. Patients will be randomised between the open or PIRS technique. The primary outcome is the number of reoperations within 2 years after primary surgery. Secondary outcome measures are: operative and postoperative complications, total duration of surgery, postoperative pain, length of admission, time to normal daily activities, cosmetic appearance of the scar, social and healthcare costs and health-related quality of life. Furthermore, cost-effectiveness will be assessed from a societal and healthcare perspective.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol was approved by the ethics committee of the Amsterdam University Medical Hospital. Informed consent will be obtained by parents and, if possible, according to age, by patient. The study will be conducted according to the principles of the Declaration of Helsinki (2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO) and Good Clinical Practice. Study findings will be disseminated through scientific publications, conferences and patient-friendly materials. The national study network of participating centres will facilitate rapid dissemination and implementation within the Netherlands and potentially abroad.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov PRS (ID\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06451432\">NCT06451432<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-110662","type":"journal-article","created":{"date-parts":[[2025,12,4]],"date-time":"2025-12-04T10:13:45Z","timestamp":1764843225000},"page":"e110662","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["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\u201316 years"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06451432","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5957-7056","authenticated-orcid":false,"given":"Sanne C","family":"Maat","sequence":"first","affiliation":[{"name":"Paediatric Surgery, Emma Kinderziekenhuis Amsterdam UMC, Amsterdam, The Netherlands"},{"name":"Universiteit van Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands"},{"name":"Amsterdam Reproduction and Development research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-1466-9631","authenticated-orcid":false,"given":"Lore Elise","family":"de Vreeze","sequence":"additional","affiliation":[{"name":"Paediatric Surgery, Emma Kinderziekenhuis Amsterdam UMC, Amsterdam, The Netherlands"},{"name":"Universiteit van Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands"},{"name":"Amsterdam Reproduction and Development research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Roxanne","family":"Eurlings","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, MosaKids Children\u2019s Hospital, Maastricht University Medical Centre, Maastricht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johannes","family":"Anema","sequence":"additional","affiliation":[{"name":"Public and Occupational Health, EMGO+ Institute for Health and Care Research Public and Occupational Health, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robertine","family":"Van Baren","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, University Medical Centre Groningen Beatrix Childrens Hospital, Groningen, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jasper V","family":"Been","sequence":"additional","affiliation":[{"name":"Department of Paediatrics, Division of Neonatology, Sophia Children\u2019s Hospital, University Medical Centre Rotterdam, Rotterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"van den Broek","sequence":"additional","affiliation":[{"name":"Department of Surgery, Maxima Medical Centre, Veldhoven, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hamit","family":"Cakir","sequence":"additional","affiliation":[{"name":"Department of Pediatric Surgery, MosaKids Children\u2019s Hospital, Maastricht University Medical Centre, Maastricht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johanna M","family":"van Dongen","sequence":"additional","affiliation":[{"name":"Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Floris","family":"Ferenschild","sequence":"additional","affiliation":[{"name":"Department of Paediatric Surgery, Amalia Children\u2019s hospital, Radboud University Medical Centre, Nijmegen, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2168-7900","authenticated-orcid":false,"given":"Jurgen","family":"C de Graaff","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Weill Cornell Medicine, New York, New York, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert","family":"Nijveldt","sequence":"additional","affiliation":[{"name":"Department of Surgery, Isala Hospital, Zwolle, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Ottenhof","sequence":"additional","affiliation":[{"name":"Department of Surgery, Flevoziekenhuis, Almere, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arianne J","family":"Ploeg","sequence":"additional","affiliation":[{"name":"Surgery, Alrijne Zorggroep, Leiderdorp, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hester","family":"Rippen","sequence":"additional","affiliation":[{"name":"Kind en Ziekenhuis, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jetske","family":"Ruiterkamp","sequence":"additional","affiliation":[{"name":"Department of Pediatric Surgery, Wilhelmina Children\u2019s Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos W R","family":"Twisk","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Data Science, Amsterdam UMC, Amsterdam, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Erik","family":"Vermeulen","sequence":"additional","affiliation":[{"name":"Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ralph","family":"De 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