Development of an international core outcome set for treatment trials in paediatric inguinal hernia: protocol for a three-phase study including a systematic review and Delphi survey.

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.

Additional Anomalies in Children with Gastroschisis and Omphalocele: A Retrospective Cohort Study.

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.

[A new technique for inguinal hernia repair in children: laparoscopic percutaneous inguinal ring suturing]. / Nieuwe behandeling voor kinderen met een liesbreuk.

Inguinal hernia repair is one of the most frequently performed operations in the pediatric population and laparoscopic hernia repair is currently increasingly performed in Dutch academic and non-academic hospitals. The laparoscopic PIRS-technique is invented by Prof. Dr. D. Patkowski and is an extra-corporeal technique that uses one trocar for the camera and uses an subcutaneous knotted suture. Compared to the open technique, the PIRS-technique offers the possibility for contralateral inspection without making an extra incision and, in case of a contralateral patent processus vaginalis (CPPV), offers the possibility for the simultaneous repair of the CPPV. This prevents the development of a metachronous contralateral inguinal hernia (MCIH), one of the most frequent reason for re-operation after open inguinal hernia repair. This will result in less operations, less exposure to general anesthesia, less hospital admissions and less visits to the general practitioner and emergency department.

Comparison of intra- and extra-corporeal laparoscopic hernia repair in children: A systematic review and pooled data-analysis.

BACKGROUND: Laparoscopic surgery is increasingly used to repair paediatric inguinal hernias and can be divided into intra- or extra-corporeal closing techniques. No statement regarding the superiority of one of the two techniques can be made. This study aims to provide evidence supporting the superiority of intra- or extra-corporeal suturing technique. METHODS: A systematic literature search was conducted using PubMed, Embase, MEDLINE, and Cochrane Library databases. Randomised controlled trials and prospective studies comparing different laparoscopic techniques were eligible for inclusion. Data were pooled using a random-effects model, comparing single-port extra-peritoneal closure to intra-peritoneal purse string suture closing. Primary outcome was recurrence rate. Secondary outcomes were duration of surgery (min), peri­ and post-operative complications (i.e. injury of spermatic vessels or spermatic cord, tuba lesions, bleeding and apnoea, haematoma/scrotal oedema, hydrocele, wound infection, iatrogenic ascent of the testis and testicular atrophy), contralateral patent processus vaginalis (CPPV) rate, post-operative pain, length of hospital stay and cosmetic appearance of the wound. RESULTS: Fifteen studies (n = 3680 patients, age range 0.5-12 years, follow-up range 3-10 months) were included is this systematic review. Intra-corporeal hernia repair was performed in 738 children and extra-corporeal repair was performed in 2942 children. A pooled data analysis could only be performed for the single port extra-corporeal closing technique and the three port intra-corporeal closing technique. We found that recurrence rate was lower in the single-port extra-corporeal closing technique compared to the intra-corporeal purse suture closing technique (0.6% vs 5.5%, 95% CI 0.107 (0.024-0.477); p < 0.001). Operation time was shorter for extra-corporeal unilateral and bilateral inguinal hernia repair compared with intra-corporeal approach, but no pooled data analysis could be performed. Due to the presence of substantial heterogeneity, it was not possible to assess other outcome measures. CONCLUSION: Single-port extra-corporeal closure seems to result in less recurrent hernias and a shorter operative time compared to intra-corporeal purse suture closing technique. No difference regarding peri­ and post-operative complications could be found and no statements regarding the length of hospital admission, post-operative pain and cosmetics could be made due to substantial heterogeneity. LEVEL OF EVIDENCE: Level II.

Injury patterns after skiing and snowboarding sports accidents.

BACKGROUND: Alpine sports are associated with risk of serious injuries. To gain insight into factors that may help reduce injury severity, accident characteristics and injury patterns were analyzed in a cohort of injured skiers and snowboarders. METHODS: All patients with Alpine sports-related injuries, reporting the injury to a leading medical assistance organization in the Netherlands in the period of 2013-2016, were contacted. Medical data were collected from the patients' files. Only ski and snowboard incidents were included. Injuries were classified according to the Abbreviated Injury Scale (AIS) and Injury Severity Scale (ISS). Data on the accident conditions, i.e. risk factors, were collected using retrospective patient-reported questionnaires. Risk factors for injuries with ISS≥9 were analysed by multivariate modelling. RESULTS: Of the 1588 included patients, 421 patients filled out the questionnaire. Skiers (N.=1370) had more knee injuries (20.4% vs. 7.4%, P<0.001), femur fractures (5.3% vs. 0.5%, P=0.002) and lower leg fractures (27.5% vs. 11.5%, P<0.001) compared to snowboarders (N.=218). Skiers were also more seriously injured (ISS>9) (P=0.01). Injured snowboarders sustained more brain concussions (8.8% vs. 15.7%, P=0.003) and lower arm fractures (5.4% vs. 16.1%, P<0.001). Only 'a higher skills level' was borderline significant for predicting serious injury (OR: 4.0 95% CI: 0.86-18.50; P=0.08). No additional risk factors were identified. CONCLUSIONS: Injury patterns after skiing and snowboarding accidents differ, injury severity differed not. Preventive measures should therefore aim to protect specific body parts depending on the type of Alpine sport. Experienced skiers and snowboarders may be more at risk for serious injuries.

Laparoscopic versus open pediatric inguinal hernia repair: state-of-the-art comparison and future perspectives from a meta-analysis.

BACKGROUND: Laparoscopic inguinal hernia repair in children is increasingly performed as it allows contralateral inspection and potentially results in shorter operation time and less complications. Evidence from meta-analyses of randomized controlled trials (RCTs) regarding the superiority of laparoscopic versus open hernia repair is lacking. METHODS: A systematic literature search was performed querying PubMed, Embase, MEDLINE, and the Cochrane Library databases. RCTs comparing laparoscopic with open hernia repair in children were considered eligible, without year and language restrictions. Cochrane Risk of Bias tool was used for quality assessment. Data were pooled using a random-effects model. Subgroup analyses were performed according to the laparoscopic suturing technique (i.e., intracorporeal or extracorporeal). RESULTS: Eight RCTs (n = 733 patients; age range 4 months-16 years) were included in this meta-analysis. Laparoscopic (LH) and open (OH) hernia repair was performed in 375 and 358 patients, respectively. Complications (seven RCTs, n = 693; pooled OR 0.50, 95% CI 0.14 to 1.79), recurrences (seven RCTs, n = 693; pooled OR 0.88, 95% CI 0.20 to 3.88), and MCIH rates (four RCTs, n = 343; pooled OR 0.28, 95% CI 0.04 to 1.86) were not different between the groups. LH resulted in shorter bilateral operation time (Five RCTs, n = 194; weighted mean difference (WMD) - 7.19, 95% CI - 10.04 to - 4.34). Unilateral operation time, length of hospital stay, and time to recovery were similar. There was insufficient evidence to assess postoperative pain and wound cosmesis, and evidence of substantial heterogeneity between the included studies. Subgroup analyses demonstrated less complications and shorter unilateral operation time for extracorporeal suturing and shorter length of hospital stay for intracorporeal suturing. CONCLUSIONS AND RELEVANCE: No definite conclusions to decide on the superiority of one of either treatment strategies can yet be drawn from the available literature. There was evidence of substantial heterogeneity and the clinical relevance of most estimated effects is very limited.