{
  "abstract": "Introduction 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—trial (HERNIIA2-trial) is to estimate the (cost-)effectiveness of the laparoscopic percutaneous internal ring suturing (PIRS) technique compared with open repair in children aged 0–16 years with a primary unilateral inguinal hernia.Methods and analysis A national multicentre randomised controlled trial will be performed including 464 children aged 0–16 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.Ethics and dissemination 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.Trial registration number ClinicalTrials.gov PRS (ID NCT06451432).",
  "authors": [
    {
      "affiliations": [
        "Paediatric Surgery, Emma Kinderziekenhuis Amsterdam UMC, Amsterdam, The Netherlands",
        "Universiteit van Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands",
        "Amsterdam Reproduction and Development research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands"
      ],
      "name": "Sanne C Maat"
    },
    {
      "affiliations": [
        "Paediatric Surgery, Emma Kinderziekenhuis Amsterdam UMC, Amsterdam, The Netherlands",
        "Universiteit van Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands",
        "Amsterdam Reproduction and Development research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands"
      ],
      "name": "Lore Elise de Vreeze"
    },
    {
      "affiliations": [
        "Department of Paediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Centre, Maastricht, The Netherlands"
      ],
      "name": "Roxanne Eurlings"
    },
    {
      "affiliations": [
        "Public and Occupational Health, EMGO+ Institute for Health and Care Research Public and Occupational Health, Amsterdam, The Netherlands"
      ],
      "name": "Johannes Anema"
    },
    {
      "affiliations": [
        "Department of Paediatric Surgery, University Medical Centre Groningen Beatrix Childrens Hospital, Groningen, The Netherlands"
      ],
      "name": "Robertine Van Baren"
    },
    {
      "affiliations": [
        "Department of Paediatrics, Division of Neonatology, Sophia Children’s Hospital, University Medical Centre Rotterdam, Rotterdam, The Netherlands"
      ],
      "name": "Jasper V Been"
    },
    {
      "affiliations": [
        "Department of Surgery, Maxima Medical Centre, Veldhoven, The Netherlands"
      ],
      "name": "Frank van den Broek"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, MosaKids Children’s Hospital, Maastricht University Medical Centre, Maastricht, The Netherlands"
      ],
      "name": "Hamit Cakir"
    },
    {
      "affiliations": [
        "Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"
      ],
      "name": "Johanna M van Dongen"
    },
    {
      "affiliations": [
        "Department of Paediatric Surgery, Amalia Children’s hospital, Radboud University Medical Centre, Nijmegen, The Netherlands"
      ],
      "name": "Floris Ferenschild"
    },
    {
      "affiliations": [
        "Department of Anesthesiology, Weill Cornell Medicine, New York, New York, USA"
      ],
      "name": "Jurgen C de Graaff"
    },
    {
      "affiliations": [
        "Department of Surgery, Isala Hospital, Zwolle, The Netherlands"
      ],
      "name": "Robert Nijveldt"
    },
    {
      "affiliations": [
        "Department of Surgery, Flevoziekenhuis, Almere, The Netherlands"
      ],
      "name": "Anne Ottenhof"
    },
    {
      "affiliations": [
        "Surgery, Alrijne Zorggroep, Leiderdorp, The Netherlands"
      ],
      "name": "Arianne J Ploeg"
    },
    {
      "affiliations": [
        "Kind en Ziekenhuis, Utrecht, The Netherlands"
      ],
      "name": "Hester Rippen"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, Wilhelmina Children’s Hospital, University Medical Centre Utrecht, Utrecht, The Netherlands"
      ],
      "name": "Jetske Ruiterkamp"
    },
    {
      "affiliations": [
        "Department of Epidemiology and Data Science, Amsterdam UMC, Amsterdam, The Netherlands"
      ],
      "name": "Jos W R Twisk"
    },
    {
      "affiliations": [
        "Department of Surgery, Spaarne Gasthuis, Haarlem, The Netherlands"
      ],
      "name": "Erik Vermeulen"
    },
    {
      "affiliations": [
        "Department of Surgery, Medisch Spectrum Twente, Enschede, The Netherlands"
      ],
      "name": "Ralph De Wit"
    },
    {
      "affiliations": [
        "Paediatric Surgery, Haga Hospital Juliana Childrens Hospital, Den Haag, The Netherlands"
      ],
      "name": "Gerda Zijp"
    },
    {
      "affiliations": [
        "Department of Pediatric Surgery, Amsterdam Reproduction and Development Research Institute, Amsterdam UMC Location AMC, Amsterdam, The Netherlands",
        "Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC Locatie VUmc, Amsterdam, The Netherlands"
      ],
      "name": "Ernest L W van Heurn"
    },
    {
      "affiliations": [
        "Universiteit van Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands",
        "Amsterdam Reproduction and Development research institute, Amsterdam UMC Locatie AMC, Amsterdam, The Netherlands",
        "Department of Paediatric Surgery, Emma Childrens’ Hospital UMC, Amsterdam, The Netherlands"
      ],
      "name": "Joep P M Derikx"
    }
  ],
  "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 0–16 years",
  "uid": "b602c5ef-e462-5bdf-bfc9-54d4fc47a454"
}