Implementing Contralateral Surgical Exploration during Hernia Repair in Children with Unilateral Inguinal Hernia: A Dutch Qualitative Study.

A total of 10-15% of children undergoing unilateral inguinal hernia repair develop a metachronous contralateral inguinal hernia (MCIH) that necessitates second anesthesia and surgery. Contralateral exploration can be performed to prevent MCIH development. This study investigates (1) factors that promote or hinder the adoption and (de-)implementation of contralateral groin exploration in children ≤ 6 months undergoing unilateral hernia repair and (2) strategies to overcome these barriers. A qualitative interview study was conducted using 14 semi-structured interviews and two focus groups involving healthcare professionals, stakeholders involved from a patients' perspective and stakeholders at the organizational/policy level. The results show that the effectiveness of surgical treatment and stakeholders' motivation and attitudes towards the intervention were reported as barriers for implementation, whereas patient and family outcomes and experience and strategies to overcome these barriers were identified as facilitating factors for future implementation. This study is unique in its contributions towards insights into facilitators and barriers for (de-)implementation of contralateral groin exploration in children with a unilateral inguinal hernia. In case the HERNIIA trial shows that contralateral exploration is beneficial for specific patient and family outcomes or a subgroup of children, the results of this study can help in the decision-making process as to whether contralateral exploration should be performed or not.

Age-specific and family-centered information modalities to prepare children at home for day-care surgery.

BACKGROUND: Surgery induced stress and anxiety in children and parents can be reduced by providing preoperative information adapted to their needs. Aim of this study was to evaluate the effects of three different information modalities (coloring page, mobile application and videos) to prepare children and their parents for day-care surgery on preoperative anxiety and postoperative pain experienced by the child, and preoperative anxiety and satisfaction of parents. METHODS: Prospective observational study including children and their parents that were offered specifically developed information modalities to prepare for day-care surgery. Results were compared between children and their parents that used none (i.e., control group) versus one or more information modalities (i.e., intervention group). Primary outcomes were preoperative anxiety measured using PROMIS v2.0 Anxiety and postoperative pain in children. Secondary outcomes were preoperative parental anxiety (STAI questionnaire) and family satisfaction with information and communication (modified PedsQL Healthcare Satisfaction questionnaire). Subgroup analyses were performed between preschoolers (0-5 years) and school-aged (≥5) children. RESULTS: 93 patients (male 53%) were included in the intervention (n=56) and control group (n=37). Levels of children's preoperative anxiety and postoperative pain, and parental anxiety did not differ between both groups. Families of prepared children were more satisfied with information and communication about preoperative surgical information (8 vs. 6.6, p=0.004) and satisfaction with how parents (7 vs 8, p=0.019) and children (8 vs 6, p=0.018) were prepared for surgery. CONCLUSIONS: Preoperative anxiety did not differ between prepared and unprepared children. The use of specifically developed family-centered and age-appropriate information modalities to prepare children for day-care surgery at home results in superior family satisfaction. LEVEL OF EVIDENCE: III.

[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.

One-Stop Surgery: An Innovation to Limit Hospital Visits in Children.

INTRODUCTION: One-stop surgery (OSS) allows for same-day outpatient clinic visit, preoperative assessment, and surgical repair. This study aims to determine the efficiency, (cost-)effectiveness, and family satisfaction of one-stop inguinal hernia surgery compared with usual care. MATERIAL AND METHODS: Children (≥ 3 months) with inguinal hernia and American Society of Anesthesiologists (ASA) grades I-II, scheduled for OSS (intervention) or regular treatment (control) between March 1, 2017, and December 1, 2018, were eligible for inclusion. Exclusion criteria consisted of age less than 3 months and ASA grades III-IV. The primary outcome measure was treatment efficiency (i.e., total number of hospital visits and waiting time [days] between referral and surgery). Secondary outcome measures were the effectiveness in terms of complication and recurrence rate, and parent-reported satisfaction and cost-effectiveness using the Dutch Pediatric Quality of Life Healthcare Satisfaction and Institute for Medical Technology Assessment Productivity Cost Questionnaire. RESULTS: Ninety-one (intervention: 54; control: 37) patients (56% boys) were included. Median (interquartile range) number of hospital visits was lower in the intervention group (1 vs 3; p < 0.001). All but one of the OSS patients (98%) were discharged home on the day of surgery. Postoperative complication (1.9% vs 2.7%; p = 0.787) and recurrence rates (0% vs 2.7%; p = 0.407) did not differ between the intervention and control patients. "General satisfaction," "satisfaction with communication," and "inclusion of family" were higher after OSS, while satisfaction about "information," "technical skills," and "emotional needs" were similar. Median (range) follow-up was 28 (15-36) months. CONCLUSIONS: Pediatric one-stop inguinal hernia repair seems to be an effective treatment strategy that limits the number of hospital visits and provides enhanced family satisfaction without compromising the quality of care.

Surgical Management of Pediatric Inguinal Hernia: A Systematic Review and Guideline from the European Pediatric Surgeons' Association Evidence and Guideline Committee.

INTRODUCTION: Inguinal hernia repair represents the most common operation in childhood; however, consensus about the optimal management is lacking. Hence, recommendations for clinical practice are needed. This study assesses the available evidence and compiles recommendations on pediatric inguinal hernia. MATERIALS AND METHODS: The European Pediatric Surgeons' Association Evidence and Guideline Committee addressed six questions on pediatric inguinal hernia repair with the following topics: (1) open versus laparoscopic repair, (2) extraperitoneal versus transperitoneal repair, (3) contralateral exploration, (4) surgical timing, (5) anesthesia technique in preterm infants, and (6) operation urgency in girls with irreducible ovarian hernia. Systematic literature searches were performed using PubMed, MEDLINE, Embase (Ovid), and The Cochrane Library. Reviews and meta-analyses were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) statement. RESULTS: Seventy-two out of 5,173 articles were included, 27 in the meta-analyses. Laparoscopic repair shortens bilateral operation time compared with open repair. In preterm infants, hernia repair after neonatal intensive care unit (NICU)/hospital discharge is associated with less respiratory difficulties and recurrences, regional anesthesia is associated with a decrease of postoperative apnea and pain. The review regarding operation urgency for irreducible ovarian hernia gained insufficient evidence of low quality. CONCLUSION: Laparoscopic repair may be beneficial for children with bilateral hernia and preterm infants may benefit using regional anesthesia and postponing surgery. However, no definite superiority was found and available evidence was of moderate-to-low quality. Evidence for other topics was less conclusive. For the optimal management of inguinal hernia repair, a tailored approach is recommended taking into account the local facilities, resources, and expertise of the medical team involved.

Contralateral surgical exploration during inguinal hernia repair in infants (HERNIIA trial): study protocol for a multi-centre, randomised controlled trial.

BACKGROUND: The incidence of metachronous contralateral inguinal hernia (MCIH) is high in infants with an inguinal hernia (5-30%), with the highest risk in infants aged 6 months or younger. MCIH is associated with the risk of incarceration and necessitates a second operation. This might be avoided by contralateral exploration during primary surgery. However, contralateral exploration may be unnecessary, leads to additional operating time and costs and may result in additional complications of surgery and anaesthesia. Thus, there is no consensus whether contralateral exploration should be performed routinely. METHODS: The Hernia-Exploration-oR-Not-In-Infants-Analysis (HERNIIA) study is a multicentre randomised controlled trial with an economic evaluation alongside to study the (cost-)effectiveness of contralateral exploration during unilateral hernia repair. Infants aged 6 months or younger who need to undergo primary unilateral hernia repair will be randomised to contralateral exploration or no contralateral exploration (n = 378 patients). Primary endpoint is the proportion of infants that need to undergo a second operation related to inguinal hernia within 1 year after primary repair. Secondary endpoints include (a) total duration of operation(s) (including anaesthesia time) and hospital admission(s); (b) complications of anaesthesia and surgery; and (c) participants' health-related quality of life and distress and anxiety of their families, all assessed within 1 year after primary hernia repair. Statistical testing will be performed two-sided with α = .05 and according to the intention-to-treat principle. Logistic regression analysis will be performed adjusted for centre and possible confounders. The economic evaluation will be performed from a societal perspective and all relevant costs will be measured, valued and analysed. DISCUSSION: This study evaluates the effectiveness and cost-effectiveness of contralateral surgical exploration during unilateral inguinal hernia repair in children younger than 6 months with a unilateral inguinal hernia. TRIAL REGISTRATION: ClinicalTrials.gov NCT03623893 . Registered on August 9, 2018 Netherlands Trial Register NL7194. Registered on July 24, 2018 Central Committee on Research Involving Human Subjects (CCMO) NL59817.029.18. Registered on July 3, 2018.

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.

Inguinal hernia in girls: A retrospective analysis of over 1000 patients.

BACKGROUND: In girls with inguinal hernia, timing of surgical repair to prevent ovarian strangulation and screening for Androgen Insensitivity Syndrome (AIS) remain controversial. This study assesses the incidence of ovarian strangulation and AIS, and its associated risk factors. METHODS: Electronic patient records were used to study girls aged 0-15 years who underwent inguinal hernia repair between 2000 and 2017. Patients with incomplete data were excluded. Risk factors were identified using logistic regression. RESULTS: This study includes 1084 girls (median (IQR) age: 133.5 (14-281) weeks) who underwent 1132 hernia repairs (1015 unilateral, 117 bilateral) within a median (IQR) time interval of 12 (6-23) days following diagnosis. Hernia sac intraoperatively contained ovary in 235 (21.7%) patients, ovary was strangulated in 14 (6%). Risk factors for ovarian strangulation were younger gestational age (OR 0.49), higher birthweight (OR 32.18), and first presentation at the emergency department (OR 13.07). However data were partly missing. Ectopic testis was found in seven (0.6%) patients. Metachronous contralateral inguinal hernia and ipsilateral recurrence developed in 6.1% and 0.3%, respectively. CONCLUSIONS: Ovarian hernia was diagnosed in 21.7%, and ovary was strangulated in 6%. No definite conclusions can be drawn regarding risk factors for strangulation and timing of surgery in girls with irreducible ovarian hernia. LEVEL OF EVIDENCE: Level III.

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.

MRI-based response patterns during neoadjuvant chemotherapy can predict pathological (complete) response in patients with breast cancer.

BACKGROUND: The main purpose was to investigate the correlation between magnetic resonance imaging (MRI)-based response patterns halfway through neoadjuvant chemotherapy and immunotherapy (NAC) and pathological tumor response in patients with breast cancer. Secondary purposes were to compare the predictive value of MRI-based response patterns measured halfway through NAC and after NAC and to measure interobserver variability. METHODS: All consecutive patients treated with NAC for primary invasive breast cancer from 2012 to 2015 and who underwent breast MRI before, halfway through (and after) NAC were included. All breast tumors were reassessed on MRI by two experienced breast radiologists and classified into six patterns: type 0 (complete radiologic response); type 1 (concentric shrinkage); type 2 (crumbling); type 3 (diffuse enhancement); type 4 (stable disease); type 5 (progressive disease). Percentages of tumors showing pathological complete response (pCR), > 50% tumor reduction and > 50% tumor diameter reduction per MRI-based response pattern were calculated. Correlation between MRI-based response patterns and pathological tumor reduction was studied with Pearson's correlation coefficient, and interobserver agreement was tested with Cohen's Kappa. RESULTS: Patients (n = 76; mean age 53, range 29-72 years) with 80 tumors (4 bilateral) were included. There was significant correlation between these MRI-based response patterns halfway through NAC and tumor reduction on pathology assessment (reader 1 r = 0.33; p = 0.003 and reader 2 r = 0.45; p < 0.001). Type-0, type-1 or type-2 patterns halfway through NAC showed highest tumor reduction rates on pathology assessment, with > 50% tumor reduction in 90%, 78% and 65% of cases, respectively. In 83% of tumors with type 0 halfway through NAC, pathology assessment showed pCR. There was no significant correlation between MRI-based response patterns after NAC and tumor reduction rates on pathology assessment (reader 1 r = - 0.17; p = 0.145 and reader 2 r = - 0.17; p = 0.146). In 41% of tumors with type 0 after NAC, pathology assessment showed pCR. CONCLUSION: MRI-based response patterns halfway through NAC can predict pathologic response more accurately than MRI-based response patterns after NAC. Complete radiological response halfway NAC is associated with 83% pCR, while complete radiological response after NAC seems to be correct in only 41% of cases.