Sanne C. Maat

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 ).

Background: An metachronous contralateral inguinal hernia (MCIH) occurs in 7%–15% of infants undergoing unilateral hernia repair, requiring a second anesthesia and surgery. Contralateral exploration (CE) can prevent development of MCIH, but also exposes infants to additional risks if no contralateral hernia is present. This study assesses the (cost)effectiveness of open primary unilateral inguinal hernia repair with and without CE in infants aged 0–6 months to prevent second surgery for MCIH. Methods: This multicenter randomized controlled trial randomly assigned infants to open unilateral inguinal hernia repair with CE (intervention group) or without CE (control group). Infants aged 0–6 months with a primary unilateral inguinal hernia undergoing open hernia repair were eligible for inclusion. The primary outcome was the number of re-operations within 1 year after the primary surgery and the subsequent number needed to treat (NNT). Secondary outcomes included operation time, hospital admission(s), complications, parental distress, and anxiety. An additional economic evaluation was performed. Results: Re-operation was performed in four out of 204 patients in the intervention group and 12 out of 198 patients in the control group [2.0% vs 6.1%, OR 95% CI 0.3 (0.1–1.0)], with a NNT of 24. Six re-operations in the control group were because of MCIH. Mean total operation time was shorter in the control group. Hospital admission, complication rate, and parental distress and anxiety did not differ between groups. The intervention had a relatively high probability of being cost-effective. Conclusion: Additional CE results in fewer re-operations compared with unilateral repair alone. However, the NNT is high ( n = 24); therefore, CE should not be implemented as standard care.

Introduction In children, open inguinal hernia repair has been the gold standard for treatment, but with recent technical advancements in laparoscopy, laparoscopic hernia repair is gaining popularity. Despite available results from comparative studies, there is still no consensus regarding the superiority of open versus laparoscopic treatment strategy. An important reason for lack of consensus is the large heterogeneity in the trials’ reported outcomes and outcome definitions, which limits comparisons between studies and precludes conclusions regarding the superiority of treatment strategies. The development and implementation of a core outcome set (COS) is a solution for this heterogeneity in the selection, measurement and reporting of trial outcome measures across studies. Currently, there is no COS for the treatment of paediatric inguinal hernia. Methods and analysis The aim of this project is to reach international consensus on a minimal set of outcomes that should be measured and reported in all future clinical trials investigating inguinal hernia repair in children. The development process comprises three phases. First, we identify outcome domains associated with paediatric inguinal hernia repair from a patient perspective and through a systematic review of the literature using EMBASE, MEDLINE and the Cochrane Library databases. Second, we conduct a three-step Delphi study to identify and prioritise ‘core’ outcomes for the eventual minimal set. In the third phase, an expert meeting is held to establish the final COS and develop implementation strategies with participants from all stakeholder groups: healthcare professionals, parents and patients’ representatives. The final COS will be reported in accordance with the COS-Standards for Reporting statement. Ethics and dissemination The medical research ethics committee of the Amsterdam UMC confirmed that the Dutch Medical Research Involving Human Subjects Act (WMO) does not apply to this study and that full approval by the committee is not required. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at relevant conferences. PROSPERO registration number CRD42021281422.

Background: Congenital abdominal wall defects might be associated with other anomalies, such as atresia in gastroschisis and cardiac anomalies in omphalocele patients. However, in the current literature, an overview of these additional anomalies and potential patient-specific risk factors is missing. Therefore, we aimed to assess the prevalence of associated anomalies and their patient-specific risk factors in patients with gastroschisis and omphalocele. Methods: A mono-center retrospective cohort study between 1997 and 2023 was performed. Outcomes were the presence of any additional anomalies. Risk factors were analyzed via logistic regression analysis. Results: In total, 122 patients were included, of whom 82 (67.2%) had gastroschisis, and 40 (32.8%) had omphalocele. Additional anomalies were identified in 26 gastroschisis patients (31.7%) and in 27 omphalocele patients (67.5%). In patients with gastroschisis, intestinal anomalies were most identified (n = 13, 15.9%), whereas, in patients with omphalocele, cardiac anomalies were most identified (n = 15, 37.5%). Logistic regression showed that cardiac anomalies were associated with complex gastroschisis (OR: 8.5; CI-95%: 1.4–49.5). Conclusions: In patients with gastroschisis and omphalocele, intestinal and cardiac anomalies were most identified, respectively. Cardiac anomalies were found to be a risk factor for patients with complex gastroschisis. Therefore, regardless of the type of gastroschisis and/or omphalocele, postnatal cardiac screening remains important.

Background: A Core Outcome Set for Inguinal Hernia repair (COS-IH) will facilitate adequate comparison of treatment strategies and the interpretation and implementation of clinical trial results. To develop such a COS-IH, this systematic review is performed to determine which outcomes are reported in RCTs and MA in children aged 0-16 years undergoing inguinal hernia repair. Methods: A systematic review was performed according to the PRISMA guidelines using PubMed, EMBASE, MEDLINE and the Cochrane Library databases (Prospero registry: CRD42021281422). This systematic review included all randomized trials (RCTs) and meta-analysis (MA) that assessed inguinal hernia repair in children. Results: A total of 96 unique outcomes were identified in the 47 included articles. These outcomes were mapped into the 62 terms as shown in table 2. Conclusion: The development of this IH-COS is crucial for outcome data comparison and will enable adequate and efficient comparison of treatment strategies, and will aid the interpretation and implementation of clinical trial results.