Publications by authors named "Nigel Hall"

111 Publications

Timing of neonatal stoma closure: a survey of health professional perspectives and current practice.

Arch Dis Child Fetal Neonatal Ed 2021 Aug 19. Epub 2021 Aug 19.

Department of Paediatric and Neonatal Surgery, Royal Manchester Children's Hospital, Manchester, UK

Optimal timing for neonatal stoma closure remains unclear. In this study, we aimed to establish current practice and illustrate multidisciplinary perspectives on timing of stoma closure using an online survey sent to all 27 UK neonatal surgical units, as part of a research programme to determine the feasibility of a clinical trial comparing 'early' and 'late' stoma closure. 166 responses from all 27 units demonstrated concordance of opinion in target time for closure (6 weeks most commonly stated across scenarios), although there was a high variability in practice. A sizeable proportion (41%) of respondents use weight, rather than time, to determine when to close a neonatal stoma. Thematic analysis of free text responses identified nine key themes influencing decision-making; most related to nutrition, growth and stoma complications. These data provide an overview of current practice that is critical to informing an acceptable trial design.
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http://dx.doi.org/10.1136/archdischild-2021-322040DOI Listing
August 2021

Prevalence of metachronous contralateral mature ovarian teratoma: A systematic review.

Pediatr Blood Cancer 2021 Jul 31:e29237. Epub 2021 Jul 31.

University Hospital Southampton NHS Foundation Trust, Southampton, UK.

There is increasing recognition that contralateral metachronous tumor may occur following treatment of unilateral mature ovarian teratoma. We aimed to define this risk to guide appropriate surveillance strategies. We undertook a systematic review of three large medical databases (Ovid Medline, Embase, and Cochrane Controlled Trials Register) to April 2020 using a defined search strategy. From 1831 articles retrieved, 23 were included, reporting 1101 girls with unilateral mature ovarian teratomas. The intensity and duration of follow-up varied between studies, with only five reporting close surveillance. Overall prevalence of metachronous contralateral mature teratoma was 2.1%, with a prevalence per study of 0%-23% (median 0%). Prevalence was higher (7%) among studies with more robust surveillance. These data suggest a small but real risk of metachronous contralateral tumors. Surveillance ultrasonography is proportionate and indicated alongside further prospective data collection to record the natural history and impact of surveillance in greater detail.
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http://dx.doi.org/10.1002/pbc.29237DOI Listing
July 2021

Management and early outcomes of children with appendicitis in the UK and Ireland during the COVID-19 pandemic: a survey of surgeons and observational study.

BMJ Paediatr Open 2020 22;4(1):e000831. Epub 2020 Oct 22.

University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.

Objectives: Acute appendicitis is the most common surgical condition in children. In the UK, appendicectomy is the most common treatment with non-operative management unusual. Due to concerns about the risk of SARS-CoV-2 transmission during surgical procedures, surgeons were advised to consider non-operative treatment and avoid laparoscopy where possible. This study aims to report management and outcomes, to date, of children with appendicitis in the UK and Ireland during the COVID-19 pandemic.

Design: Survey of consultant surgeons who treat children with appendicitis that informed a prospective multicentre observational cohort study.

Setting: Data were collected from centres in the UK and Ireland for cases admitted between 1 April and 31 May 2020 (first 2 months of the COVID-19 pandemic) at both general surgical and specialist paediatric surgical centres.

Participants: The study cohort includes 838 children with a clinical and/or radiological diagnosis of acute appendicitis of which 527 (63%) were male.

Main Outcomes Measured: Primary outcome was treatment strategy used for acute appendicitis. Other outcomes reported include change in treatment strategy over time, use of diagnostic imaging and important patient outcomes to 30 days following hospital admission.

Results: From very early in the pandemic surgeons experienced a change in their management of children with appendicitis and almost all surgeons who responded to the survey anticipated further changes during the pandemic. Overall, 326/838 (39%) were initially treated non-operatively of whom 81/326 (25%) proceeded to appendicectomy within the initial hospital admission. Of cases treated initially surgically 243/512 (48%) were performed laparoscopically. Diagnostic imaging was used in 445/838 (53%) children. Cases treated non-operatively had a shorter hospital stay than those treated surgically but hospital readmissions within 30 days were similar between groups. In cases treated surgically the negative appendicectomy rate was 4.5%. There was a trend towards increased use of surgical treatment and from open to laparoscopic appendicectomy as the pandemic progressed.

Conclusion: Non-operative treatment of appendicitis has been widely used for the first time in children in the UK and Ireland and is safe and effective in selected patients. Overall patient outcomes do not appear to have been adversely impacted by change in management during the pandemic thus far.
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http://dx.doi.org/10.1136/bmjpo-2020-000831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7582338PMC
October 2020

Surgical necrotizing enterocolitis: Association between surgical indication, timing, and outcomes.

J Pediatr Surg 2021 Oct 2;56(10):1785-1790. Epub 2021 May 2.

University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton SO16 6YD, UK. Electronic address:

Background/purpose: Despite improvements in neonatal care the outcomes of Necrotizing Enterocolitis (NEC) remain unchanged over previous decades. The study aims to explore whether different indications for surgical intervention in NEC are associated with timing of surgery and outcomes.

Methods: Population-based, prospective, observational study of all 27 paediatric surgical centres in the United Kingdom and Ireland identified using the British Association of Paediatric Surgeons Congenital Anomalies Surveillance System from 1st February 2013 to 28th February 2014. Infants were included if they had NEC and underwent first surgical intervention within 7 days of diagnosis. Primary outcomes were death, parenteral nutrition requirement or a composite outcome of death or PN requirement at 28 days post surgery.

Results: There were 133 infants meeting inclusion criteria. Indications for surgery were bowel perforation (n = 67), suspected necrotic bowel without bowel perforation and not deemed to have failed medical management (n = 20), those who had failed medical management (n = 42) and a palpable mass without any other indication (n = 4). Failed medical treatment as an indication for surgery was associated with an increased time to surgery of 30.28 (95% CI 13.46-47.10) hours from those whose indication was perforation and was also the strongest predictor of PN requirement or death at 28 days post-surgery (OR 4.54 [1.59-13.0]).

Conclusions: Failed medical treatment as an indication for surgery for NEC is associated with poor outcome. Earlier intervention in these infants represents a potential opportunity to improve outcomes in this population.
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http://dx.doi.org/10.1016/j.jpedsurg.2021.04.028DOI Listing
October 2021

Conservative treatment for uncomplicated appendicitis in children: the CONTRACT feasibility study, including feasibility RCT.

Health Technol Assess 2021 Feb;25(10):1-192

Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Liverpool, UK.

Background: Although non-operative treatment is known to be effective for the treatment of uncomplicated acute appendicitis in children, randomised trial data comparing important outcomes of non-operative treatment with those of appendicectomy are lacking.

Objectives: The objectives were to ascertain the feasibility of conducting a multicentre randomised controlled trial comparing the clinical effectiveness and cost-effectiveness of a non-operative treatment pathway with appendicectomy for the treatment of uncomplicated acute appendicitis in children.

Design: This was a mixed-methods study, which included a feasibility randomised controlled trial, embedded and parallel qualitative and survey studies, a parallel health economic feasibility study and the development of a core outcome set.

Setting: This study was set in three specialist NHS paediatric surgical units in England.

Participants: Children (aged 4-15 years) clinically diagnosed with uncomplicated acute appendicitis participated in the feasibility randomised controlled trial. Children, their families, recruiting clinicians and other health-care professionals involved in caring for children with appendicitis took part in the qualitative study. UK specialist paediatric surgeons took part in the survey. Specialist paediatric surgeons, adult general surgeons who treat children, and children and young people who previously had appendicitis, along with their families, took part in the development of the core outcome set.

Interventions: Participants in the feasibility randomised controlled trial were randomised to a non-operative treatment pathway (broad-spectrum antibiotics and active observation) or appendicectomy.

Main Outcome Measures: The primary outcome measure was the proportion of eligible patients recruited to the feasibility trial.

Data Sources: Data were sourced from NHS case notes, questionnaire responses, transcribed audio-recordings of recruitment discussions and qualitative interviews.

Results: Overall, 50% (95% confidence interval 40% to 59%) of 115 eligible patients approached about the trial agreed to participate and were randomised. There was high acceptance of randomisation and good adherence to trial procedures and follow-up (follow-up rates of 89%, 85% and 85% at 6 weeks, 3 months and 6 months, respectively). More participants had perforated appendicitis than had been anticipated. Qualitative work enabled us to communicate about the trial effectively with patients and families, to design and deliver bespoke training to optimise recruitment and to understand how to optimise the design and delivery of a future trial. The health economic study indicated that the main cost drivers are the ward stay cost and the cost of the operation; it has also informed quality-of-life assessment methods for future work. A core outcome set for the treatment of uncomplicated acute appendicitis in children and young people was developed, containing 14 outcomes. There is adequate surgeon interest to justify proceeding to an effectiveness trial, with 51% of those surveyed expressing a willingness to recruit with an unchanged trial protocol.

Limitations: Because the feasibility randomised controlled trial was performed in only three centres, successful recruitment across a larger number of sites cannot be guaranteed. However, the qualitative work has informed a bespoke training package to facilitate this. Although survey results suggest adequate clinician interest to make a larger trial possible, actual participation may differ, and equipoise may have changed over time.

Conclusions: A future effectiveness trial is feasible, following limited additional preparation, to establish appropriate outcome measures and case identification. It is recommended to include a limited package of qualitative work to optimise recruitment, in particular at new centres.

Future Work: Prior to proceeding to an effectiveness trial, there is a need to develop a robust method for distinguishing children with uncomplicated acute appendicitis from those with more advanced appendicitis, and to reach agreement on a primary outcome measure and effect size that is acceptable to all stakeholder groups involved.

Trial Registration: Current Controlled Trials ISRCTN15830435.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 25, No. 10. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta25100DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7958256PMC
February 2021

International Core Outcome Set for Acute Simple Appendicitis in Children: Results of A Systematic Review, Delphi Study, and Focus Groups with Young People.

Ann Surg 2020 Dec 29. Epub 2020 Dec 29.

*Department of Pediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit, Amsterdam, The Netherlands †University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton General Hospital, Southampton, UK; Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK ‡Parent and Patient representative, USA §Pediatric clinical Research Office, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands ¶Knowledge Institute of the Dutch Association of Medical Specialists, Utrecht, The Netherlands ||Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Canada **Center for Surgical Outcomes Research, Abigail Wexner Research Institute and Department of Surgery, Nationwide Children's Hospital, Columbus, OH, USA ††Department of Pediatric Surgery, Karolinska University Hospital, Stockholm, Sweden; Department of Women's and Children's Health, Karolinska Institute, Stockholm, Sweden ‡‡Department of Surgery, Children's Mercy Hospital, Kansas City, MO, USA §§Department of Pediatric Surgery, Sydney Children's Hospital, Randwick, NSW, Australia, School of Women's and Children's Health, University of New South Wales ¶¶Department of Pediatric Surgery, KK Women's and Children's Hospital, Singapore, Singapore ||||Division of Paediatric Surgery, Department of Surgery, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia ***Department of Pediatric Surgery, British Columbia Children's Hospital, Vancouver, BC, Canada †††Division of General and Thoracic Surgery, The Hospital for Sick Children, Toronto, ON, Canada ‡‡‡Department of Surgery, University of Toronto, Toronto, ON, Canada §§§Harvey E. Beardmore Division of Pediatric Surgery, Montreal Children's Hospital, Montreal, QC, Canada ¶¶¶Department of Pediatric Surgery, Helsinki Children's Hospital, Helsinki, Finland ||||||Department of Pediatric Surgery, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia ****Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada.

Objective:: To develop an international Core Outcome Set (COS), a minimal collection of outcomes that should be measured and reported in all future clinical trials evaluating treatments of acute simple appendicitis in children.

Summary Background Data: A previous systematic review identified 115 outcomes in 60 trials and systematic reviews evaluating treatments for children with appendicitis, suggesting the need for a COS.

Methods: The development process consisted of four phases: (1) an updated systematic review identifying all previously reported outcomes, (2) a two-stage international Delphi study in which parents with their children and surgeons rated these outcomes for inclusion in the COS, (3) focus groups with young people to identify missing outcomes, and (4) international expert meetings to ratify the final COS.

Results: The systematic review identified 129 outcomes which were mapped to 43 unique outcome terms for the Delphi survey. The first-round included 137 parents (eight countries) and 245 surgeons (10 countries), the second-round response rates were 61% and 85% respectively, with ten outcomes emerging with consensus. After two young peoples' focus groups, two additional outcomes were added to the final COS (12): mortality, bowel obstruction, intra-abdominal abscess, recurrent appendicitis, complicated appendicitis, return to baseline health, readmission, reoperation, unplanned appendectomy, adverse events related to treatment, major and minor complications.

Conclusion: An evidence-informed COS based on international consensus, including patients and parents has been developed. This COS is recommended for all future studies evaluating treatment of simple appendicitis in children, to reduce heterogeneity between studies and facilitate data synthesis and evidence-based decision-making.
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http://dx.doi.org/10.1097/SLA.0000000000004707DOI Listing
December 2020

Compliance with UK national guidance for elective surgery during the COVID-19 pandemic.

Arch Dis Child 2021 04 18;106(4):e26. Epub 2021 Feb 18.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK.

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http://dx.doi.org/10.1136/archdischild-2020-321445DOI Listing
April 2021

CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT).

Arch Dis Child 2021 Jan 13. Epub 2021 Jan 13.

Centre for Surgical Research and NIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Objective: To establish the feasibility of a multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy in children with uncomplicated acute appendicitis.

Design: Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.

Setting: Three specialist paediatric surgery centres in the UK.

Patients: Children (aged 4-15 years) with a clinical diagnosis of uncomplicated acute appendicitis.

Interventions: Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).

Main Outcome Measures: Primary outcome measure was the proportion of eligible patients recruited. Secondary outcomes evaluated adherence to interventions, data collection during follow-up, safety of treatment pathways and clinical course.

Results: Fifty per cent of eligible participants (95% CI 40 to 59) approached about the trial agreed to participate and were randomised. Repeated bespoke recruiter training was associated with an increase in recruitment rate over the course of the trial from 38% to 72%. There was high acceptance of randomisation, good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Although more participants had perforated appendicitis than had been anticipated, treatment pathways were found to be safe and adverse event profiles acceptable.

Conclusion: Recruitment to a randomised controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.

Trial Registration Number: ISRCTN15830435.
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http://dx.doi.org/10.1136/archdischild-2020-320746DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311091PMC
January 2021

One-year Outcomes of Congenital Duodenal Obstruction: A Population-based Study.

J Pediatr Gastroenterol Nutr 2021 02;72(2):239-243

University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton.

Objectives: Congenital duodenal obstruction (CDO) occurs in 1.2 per 10,000 live births and is frequently associated with other anomalies, most commonly cardiac. The aim of this study was to report important outcomes to 1 year following surgical repair.

Methods: This was a prospective population-based study using the British Association of Paediatric Surgeons Congenital Anomaly Surveillance System. Cases were identified at specialist pediatric surgical centres in the United Kingdom during a 12-month period starting in March 2016. Outcomes were recorded at 1 year following surgical repair.

Results: There were 100 infants with possible follow-up at 1 year and follow-up was achieved in 80 of these (80%) of whom 76 were alive at 1 year. The remainder had been discharged home, although one remained on parenteral nutrition. Five (6.1%) infants underwent repeat surgery for reasons related to CDO and overall 23 (23%) experienced at least 1 central venous catheter-related complication within 1 year. Overall mortality either before repair or within 1 year following surgical repair was 8.4% (95% CI 2.5%-14.4%), no deaths were related to CDO.

Conclusions: One year outcomes for CDO are generally very good with poor outcomes typically related to comorbidities. These data are useful for national benchmarking and parental counselling.
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http://dx.doi.org/10.1097/MPG.0000000000002921DOI Listing
February 2021

Association Between Administration of Antacid Medication and Anastomotic Stricture Formation After Repair of Esophageal Atresia.

J Surg Res 2020 10 7;254:334-339. Epub 2020 Jun 7.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK; University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK. Electronic address:

Background: Anastomotic stricture is a significant cause of morbidity after repair of esophageal atresia (EA). Exposure to gastric acid has been postulated to contribute to stricture development and severity leading to prophylactic antacid use by some surgeons. We investigated the association between administration of antacid medication and the development of anastomotic strictures.

Methods: Retrospective case-note review of consecutive infants undergoing repair of EA with distal tracheoesophageal fistula (type C) between January 1994 and December 2014. Only infants who underwent primary esophageal anastomosis at initial surgical procedure were included. Stricture-related outcomes were compared initially for infants who received prophylactic antacid medication (PAAM) versus no prophylaxis, and the role of PAAM in stricture prevention was explored in a multivariate model. Outcomes were also compared for infants grouped by antacid use at any stage.

Results: One hundred fourteen infants were included. Sixteen infants received PAAM at surgeon preference. Of the remaining 98 infants, 44 subsequently received antacid as treatment for gastroesophageal reflux (GER) and 54 never received antacid medication. There was no statistically significant association between incidence of stricture in the first year (10 of 16 versus 41 of 98; P = 0.18) nor time to first stricture (median, 57 d [41-268] versus 102 d [43-320]; P = 0.89) and administration of PAAM. Similarly, there were no statistically significant associations between incidence of stricture, age at first stricture and number of dilatations, and administration of antacid medication either as prophylaxis nor when given as treatment for symptoms or signs of GER.

Conclusions: These data do not support the hypothesis that PAAM reduces the incidence or severity of anastomotic stricture after repair of EA. Treatment with antacids may be best reserved for those with symptoms or signs of GER. Further prospective investigation of the role of antacid prophylaxis on stricture formation after EA repair is warranted.
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http://dx.doi.org/10.1016/j.jss.2020.05.004DOI Listing
October 2020

Application of the matched nested case-control design to the secondary analysis of trial data.

BMC Med Res Methodol 2020 05 14;20(1):117. Epub 2020 May 14.

National Perinatal Epidemiology Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.

Background: A nested case-control study is an efficient design that can be embedded within an existing cohort study or randomised trial. It has a number of advantages compared to the conventional case-control design, and has the potential to answer important research questions using untapped prospectively collected data.

Methods: We demonstrate the utility of the matched nested case-control design by applying it to a secondary analysis of the Abnormal Doppler Enteral Prescription Trial. We investigated the role of milk feed type and changes in milk feed type in the development of necrotising enterocolitis in a group of 398 high risk growth-restricted preterm infants.

Results: Using matching, we were able to generate a comparable sample of controls selected from the same population as the cases. In contrast to the standard case-control design, exposure status was ascertained prior to the outcome event occurring and the comparison between the cases and matched controls could be made at the point at which the event occurred. This enabled us to reliably investigate the temporal relationship between feed type and necrotising enterocolitis.

Conclusions: A matched nested case-control study can be used to identify credible associations in a secondary analysis of clinical trial data where the exposure of interest was not randomised, and has several advantages over a standard case-control design. This method offers the potential to make reliable inferences in scenarios where it would be unethical or impractical to perform a randomised clinical trial.
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http://dx.doi.org/10.1186/s12874-020-01007-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7227268PMC
May 2020

Ensuring young voices are heard in core outcome set development: international workshops with 70 children and young people.

Res Involv Engagem 2020 6;6:19. Epub 2020 May 6.

1Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 223, Second Floor, Block B, Waterhouse Building, 1-5 Dover Street, Liverpool, L69 3GL UK.

Plain English Summary: Researchers test treatments to ensure these work and are safe. They do this by studying the effects that treatments have on patients by measuring outcomes, such as pain and quality of life. Often research teams measure different outcomes even though each team is studying the same condition. This makes it hard to compare the findings from different studies and it can reduce the accuracy of the treatment advice available to patients. Increasingly, researchers are tackling this problem by developing 'core outcome sets'. These are lists of outcomes that all researchers working on a given condition should measure in their studies. It is important that patients have a voice in the development of core outcome sets and children and young people are no exception. But their voices have rarely been heard when core outcome sets are developed. Researchers are trying to address this problem and make sure that core outcome sets are developed in ways that are suitable for children and young people. As a first step, we held two international workshops with children and young people to listen to their views. They emphasised the importance of motivating young people to participate in developing core outcome sets, making them feel valued, and making the development process more interactive, enjoyable and convenient. We hope this commentary will encourage researchers to include children and young people when developing core outcome sets and to adapt their methods so these are suitable for young participants. Future research is important to examine whether these adaptations are effective.

Abstract: Different research teams looking at treatments for the same condition often select and measure inconsistent treatment outcomes. This makes it difficult to synthesise the results of different studies, leads to selective outcome reporting and impairs the quality of evidence about treatments. 'Core outcome sets' (COS) can help to address these problems. A COS is an agreed, minimum list of outcomes that researchers are encouraged to consistently measure and report in their studies. Including children and young people (CYP) as participants in the development of COS for paediatric conditions ensures that clinically meaningful outcomes are measured and reported. However, few published COS have included CYP as participants. COS developers have described difficulties in recruiting and retaining CYP and there is a lack of guidance on optimising COS methods for them. We aimed to explore CYP's views on the methods used to develop COS and identify ways to optimise these methods. This commentary summarises discussions during two workshops with approximately 70 CYP (aged 10-18 years old) at the International Children's Advisory Network Research and Advocacy Summit, 2018. Delegates described what might motivate them to participate in a COS study, including feeling valued, understanding the need for COS and the importance of input from CYP in their development, and financial and other incentives (e.g. certificates of participation). For Delphi surveys, delegates suggested that lists of outcomes should be as brief as possible, and that scoring and feedback methods should be simplified. For consensus meetings, delegates advised preparing CYP in advance, supporting them during meetings (e.g. via mentors) and favoured arrangements whereby CYP could meet separately from parents and other stakeholders. Overall, they wanted COS methods that were convenient, enjoyable and engaging. This commentary points to the limitations of the methods currently used to develop COS with CYP. It also points to ways to motivate CYP to participate in COS studies and to enhancements of methods to make participation more engaging for CYP. Pending much needed research on COS methods for CYP, the perspectives offered in the workshops should help teams developing COS in paediatrics and child health.
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http://dx.doi.org/10.1186/s40900-020-00202-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7201753PMC
May 2020

Enhancing communication, informed consent and recruitment in a paediatric urgent care surgical trial: a qualitative study.

BMC Pediatr 2020 03 30;20(1):140. Epub 2020 Mar 30.

Institute of Population Health Sciences, University of Liverpool, Room 223, Second Floor, Block B, Waterhouse Building, 1-5 Dover Street, Liverpool, L3 5DA, UK.

Background: Recruiting patients to paediatric trials can be challenging, especially in trials that compare markedly different management pathways and are conducted in acute settings. We aimed to enhance informed consent and recruitment in the CONTRACT trial (CONservative TReatment of Appendicitis in Children a randomised controlled Trial; ISRCTN15830435) - a feasibility trial that compared non-operative treatment (antibiotics) versus appendicectomy for uncomplicated acute appendicitis.

Methods: Qualitative study embedded within CONTRACT and conducted across three UK children's hospitals. Data were transcribed audio-recordings of 85 CONTRACT recruitment consultations with 58 families; and semi-structured interviews with 35 health professionals and 28 families (34 parents, 14 children) invited to participate in CONTRACT. Data analysis drew on thematic approaches. Throughout CONTRACT, we used findings from the ongoing qualitative analysis to inform bespoke communication training for health professionals recruiting to CONTRACT. Before and after training we also examined qualitative changes in communication during consultations and quantitative changes in recruitment rates.

Results: Bespoke communication training focussed on presenting the trial arms in a balanced way, emphasising clinical equipoise, exploring family treatment preferences and managing families' expectations about the trial's treatment pathways. Analysis of recruitment consultations indicated that health professionals' presentation of treatment arms became increasingly balanced following training, (e.g. avoiding imbalanced terminology) and recruitment rose from 38 to 62%. However, they remained reluctant to explore families' treatment preferences and respond with further information to balance these preferences. Analyses of interviews identified the time constraints of the urgent care setting, concerns about coercion, and reservations about exposing children to conversations about treatment risks as reasons for this reluctance. Interviews with families indicated the importance of clear explanations of trial treatment timings and sensitive communication of treatment allocation for both recruitment and retention.

Conclusions: Following bespoke training based on the qualitative analyses, health professionals presented CONTRACT to families in clearer and more balanced ways and this was associated with an increase in the recruitment rate. Despite training, health professionals remained reluctant to explore families' treatment preferences. We provide several recommendations to enhance communication, informed consent, recruitment and retention in future trials in urgent care settings.
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http://dx.doi.org/10.1186/s12887-020-02040-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7106711PMC
March 2020

The impact of trisomy 21 on epidemiology, management, and outcomes of congenital duodenal obstruction: a population-based study.

Pediatr Surg Int 2020 Apr 29;36(4):477-483. Epub 2020 Feb 29.

University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, SO16 6YD, UK.

Purpose: Congenital duodenal obstruction (CDO) is associated with trisomy 21 (T21), or Down's syndrome, in around a third of infants. The aim of this study was to explore the impact of T21 on the epidemiology, management, and outcomes of infants with CDO.

Methods: Data were prospectively collected from specialist neonatal surgical centres in the United Kingdom over a 12 month period from March 2016 using established population-based methodology for all babies with CDO. Infants with T21 were compared to those without any chromosomal anomaly.

Results: Of 102 infants with CDO that underwent operative repair, T21 was present in 33 [32% (95% CI 23-41%)] babies. Cardiac anomalies were more common in those with T21 compared to those without a chromosomal anomaly (91 vs 17%, p < 0.001), whereas associated gastrointestinal anomalies were less common in infants with T21 (3 vs 12%, p = 0.03). Surgical management was not influenced by T21. Time to achieve full enteral feed, need for repeat related surgery, and mortality were similar between groups. Infants with T21 had a longer median initial inpatient stay (23 vs 16.5 days, p = 0.02).

Conclusions: Infants with T21 have a higher incidence of cardiac anomalies and a longer initial inpatient stay; however, it does not change CDO management or outcomes. This information is important for prenatal and postnatal counselling of parents of infants with CDO and T21.
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http://dx.doi.org/10.1007/s00383-020-04628-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7069923PMC
April 2020

Implementing an early feeding pathway post gastrostomy insertion reduces inpatient stay.

J Pediatr Surg 2020 May 13;55(5):861-865. Epub 2020 Feb 13.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK; University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK. Electronic address:

Background: There is no consensus regarding optimal postoperative feeding strategy following gastrostomy insertion in children. The aim of this study was to determine whether implementing an early postoperative feeding pathway reduces length of stay (LOS) without increasing complications.

Methods: A retrospective case note review of all children having a new gastrostomy inserted during a one-year period prior to (July 2016-July 2017) and following (July 2017-July 2018) pathway introduction was performed. Children unable to follow the pathway for coexisting medical or nutritional reasons were excluded. The pathway comprised feeding 50% of normal feed 2 hours postprocedure, followed by 100% of normal feed at 5 and 8 h. Previously, patients were fed postoperatively according to surgeon preference.

Results: 116 cases met inclusion criteria, 55 prior to and 61 after pathway implementation. Children following the early feeding pathway had a shorter postoperative LOS than the historical group (median 28 vs 33 h, p < 0.003), while immediate (<72 h) and early (<30 day) complication rates were similar (8.2 vs 7.3%, p = 1.00 and 12 vs 16%, p = 0.59, respectively).

Conclusions: Early postoperative feeding after gastrostomy insertion is safe and reduces LOS.

Type Of Study: Quality improvement.

Level Of Evidence: III.
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http://dx.doi.org/10.1016/j.jpedsurg.2020.01.024DOI Listing
May 2020

Contemporary Outcomes for Infants with Necrotizing Enterocolitis-A Systematic Review.

J Pediatr 2020 05 22;220:86-92.e3. Epub 2020 Jan 22.

Department of Pediatric Surgery, Southampton Children's Hospital, Southampton, United Kingdom; Faculty of Medicine, University of Southampton, Southampton, United Kingdom.

Objective: To develop an accurate understanding of outcomes for necrotizing enterocolitis (NEC) to inform parental counseling, clinical care, and research agendas.

Study Design: A systematic review of recent (January 2010-January 2018) large cohort studies reporting outcomes of infants who developed NEC. Only studies reporting national, regional, or multicenter outcomes of NEC in high income countries were included. Outcomes assessed were mortality, neurodevelopmental outcome, and intestinal failure. Meta-analyses were used to generate summary statistics for these outcomes.

Results: Of 1375 abstracts, 38 articles were included. Overall mortality was 23.5% in all neonates with confirmed NEC (Bell stage 2a+) (95% CI 18.5%-28.8%), 34.5% (30.1%-39.2%) for neonates that underwent surgery for NEC, 40.5% (37.2%-43.8%) for extremely low birthweight infants (<1000 g), and 50.9% (38.1%-63.5%) for extremely low birthweight infants with surgical NEC. Studies examining causes of neonatal mortality showed NEC is responsible for around 1 in 10 of all neonatal deaths. Neurodevelopmental disability was reported in 4 studies at between 24.8% and 61.1% (1209 total NEC cases). Three studies reported intestinal failure with an incidence of 15.2%-35.0% (n = 1370). The main limitation of this review is the lack of an agreed definition for diagnosing NEC and the differences in the way that outcomes are reported.

Conclusions: Mortality following NEC remains high. These contemporary data inform clinical care and justify ongoing research efforts. All infants with NEC should have long-term neurodevelopmental assessment. Data on the long-term risk of intestinal failure are limited.

Trial Registration: CRD42018094791.
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http://dx.doi.org/10.1016/j.jpeds.2019.11.011DOI Listing
May 2020

A Delphi Analysis to Reach Consensus on Preoperative Care in Infants with Hypertrophic Pyloric Stenosis.

Eur J Pediatr Surg 2020 Dec 20;30(6):497-504. Epub 2020 Jan 20.

Department of Pediatric Surgery, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam & Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Introduction:  Infantile hypertrophic pyloric stenosis (IHPS) is a common gastrointestinal condition that can lead to metabolic alkalosis and, if uncorrected, to respiratory complications. A standardized approach to correct metabolic derangements and dehydration may reduce time until pyloromyotomy while preventing potential respiratory complications. Such an evidence-based policy regarding preoperative care is absent. We aim to formulate a recommendation about preoperative care for infants with IHPS using the Delphi technique.

Materials And Methods:  The RAND/UCLA appropriateness method was used to reach international consensus in a panel of pediatric surgeons, pediatric anesthetists, and pediatricians. Statements on type and frequency of blood sampling, required serum concentrations before pyloromyotomy and intravenous fluid therapy, were rated online using a 9-point Likert scale. Consensus was present if the panel rated the statement appropriate/obligatory (panel median: 7-9) or inappropriate/unnecessary (panel median: 1-3) without disagreement according to the interpercentile range adjusted for symmetry formula.

Results:  Thirty-three and twenty-nine panel members completed the first and second round, respectively. Consensus was reached in 54/74 statements (73%). The panel recommended the following laboratory tests and corresponding cutoff values prior to pyloromyotomy: pH ≤7.45, base excess ≤3.5, bicarbonate <26 mmol/L, sodium ≥132 mmol/L, potassium ≥3.5 mmol/L, chloride ≥100 mmol/L, and glucose ≥4.0 mmol/L. Isotonic crystalloid with 5% dextrose and 10 to 20 mEq/L potassium should be used for fluid resuscitation.

Conclusion:  Consensus is reached in an expert panel about assessment of metabolic derangements at admission, cutoff serum concentrations to be achieved prior to pyloromyotomy, and appropriate intravenous fluid regime for the correction of dehydration and metabolic derangements in infants with IHPS.
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http://dx.doi.org/10.1055/s-0039-3401987DOI Listing
December 2020

Prognostic value of prenatally detected small or absent fetal stomach with particular reference to oesophageal atresia.

Arch Dis Child Fetal Neonatal Ed 2020 May 19;105(3):341-342. Epub 2019 Nov 19.

Wessex Clinical Genetic Service, University Hospital Southampton, Southampton, UK.

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http://dx.doi.org/10.1136/archdischild-2019-317959DOI Listing
May 2020

Core outcomes in neonatology: development of a core outcome set for neonatal research.

Arch Dis Child Fetal Neonatal Ed 2020 Jul 15;105(4):425-431. Epub 2019 Nov 15.

Academic Neonatal Medicine, Imperial College London, London, UK.

Background: Neonatal research evaluates many different outcomes using multiple measures. This can prevent synthesis of trial results in meta-analyses, and selected outcomes may not be relevant to former patients, parents and health professionals.

Objective: To define a core outcome set (COS) for research involving infants receiving neonatal care in a high-income setting.

Design: Outcomes reported in neonatal trials and qualitative studies were systematically reviewed. Stakeholders were recruited for a three-round international Delphi survey. A consensus meeting was held to confirm the final COS, based on the survey results.

Participants: Four hundred and fourteen former patients, parents, healthcare professionals and researchers took part in the eDelphi survey; 173 completed all three rounds. Sixteen stakeholders participated in the consensus meeting.

Results: The literature reviews identified 104 outcomes; these were included in round 1. Participants proposed 10 additional outcomes; 114 outcomes were scored in rounds 2 and 3. Round 1 scores showed different stakeholder groups prioritised contrasting outcomes. Twelve outcomes were included in the final COS: survival, sepsis, necrotising enterocolitis, brain injury on imaging, general gross motor ability, general cognitive ability, quality of life, adverse events, visual impairment/blindness, hearing impairment/deafness, retinopathy of prematurity and chronic lung disease/bronchopulmonary dysplasia.

Conclusions And Relevance: A COS for clinical trials and other research studies involving infants receiving neonatal care in a high-income setting has been identified. This COS for neonatology will help standardise outcome selection in clinical trials and ensure these are relevant to those most affected by neonatal care.
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http://dx.doi.org/10.1136/archdischild-2019-317501DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7363790PMC
July 2020

Congenital duodenal obstruction in the UK: a population-based study.

Arch Dis Child Fetal Neonatal Ed 2020 Mar 22;105(2):178-183. Epub 2019 Jun 22.

University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.

Objective: Congenital duodenal obstruction (CDO) comprising duodenal atresia or stenosis is a rare congenital anomaly requiring surgical correction in early life. Identification of variation in surgical and postoperative practice in previous studies has been limited by small sample sizes. This study aimed to prospectively estimate the incidence of CDO in the UK, and report current management strategies and short-term outcomes.

Design: Prospective population-based, observational study for 12 months from March 2016.

Setting: Specialist neonatal surgical units in the UK.

Main Outcome Measures: Incidence of CDO, associated anomalies and short-term outcomes.

Results: In total, 110 cases were identified and data forms were returned for 103 infants giving an estimated incidence of 1.22 cases per 10 000 (95% CI 1.01 to 1.49) live births. Overall, 59% of cases were suspected antenatally and associated anomalies were seen in 69%. Operative repair was carried out mostly by duodenoduodenostomy (76%) followed by duodenojejunostomy (15%). Postoperative feeding practice varied with 42% having a trans-anastomotic tube placed and 88% receiving parenteral nutrition. Re-operation rate related to the initial procedure was 3% within 28 days. Two infants died within 28 days of operation from unrelated causes.

Conclusion: This population-based study of CDO has shown that the majority of infants have associated anomalies. There is variation in postoperative feeding strategies which represent opportunities to explore the effects of these on outcome and potentially standardise approach. Short-term outcomes are generally good.
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http://dx.doi.org/10.1136/archdischild-2019-317085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7063389PMC
March 2020

Growth pattern of infants with gastroschisis in the neonatal period.

Clin Nutr ESPEN 2019 08 29;32:82-87. Epub 2019 May 29.

Developmental Biology and Cancer Programme, UCL Great Ormond Street Institute of Child Health, London, UK.

Background/aim: Early postnatal growth patterns may have significant long term health effects. Although preterm infants on parenteral nutrition (PN) exhibit poor growth, growth pattern of term or near-term infants requiring PN is not well reported. We aimed to investigate this in infants born with gastroschisis.

Methods: Retrospective review of all infants with gastroschisis requiring PN treated at a single centre over a 4 year period. Growth and clinical data were retrieved, and weight SDS scores for corrected gestational age calculated. Weight SDS (mean ± SD) were compared at clinically relevant timepoints and multi-level regression used to model growth trends over time.

Main Results: During the study period 61 infants with gastroschisis were treated; all were included. Infants were small for gestational age at birth for weight (SDS score -0.87 ± 0.85). Weight SDS decreased significantly during the first 10 days of age (mean decrease 0.81 ± 0.56; p < 0.0001) and between birth and discharge (mean decrease 0.81 ± 0.56; p < 0.0001). Despite tolerating full enteral feeds, weight SDS velocity was negative around the time of transition from parenteral to enteral feed. There was evidence of 'catch up' growth between 3 and 6 months of age.

Conclusion: Despite nutritional support with PN, infants with gastroschisis demonstrate significant growth failure during the newborn period. Further efforts are required to understand the underlying mechanisms, improve nutritional support and to evaluate the long term consequences of postnatal growth failure in this population.
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http://dx.doi.org/10.1016/j.clnesp.2019.04.008DOI Listing
August 2019

Establishing a core outcome set for treatment of uncomplicated appendicitis in children: study protocol for an international Delphi survey.

BMJ Open 2019 05 22;9(5):e028861. Epub 2019 May 22.

Paediatric Surgical Centre, Emma Children's Hospital, Amsterdam UMC, University of Amsterdam, Vrije Universiteit, Amsterdam, The Netherlands.

Introduction: Appendicitis is a global disease affecting roughly 1 in every 12 people in the world, with the highest incidence between ages 10 and 19 years. To date, a wide variety of health outcomes have been reported in randomised controlled trials and meta-analyses evaluating treatments for appendicitis. This is especially the case in studies comparing non-operative treatment with operative treatment. A set of standard outcomes, to be reported in all future trials, is needed to allow for adequate comparison and interpretation of clinical trial results and to make data pooling possible. This protocol describes the development of such a global core outcome set (COS) to allow unified reporting of treatment interventions in children with acute uncomplicated appendicitis.

Methods And Analysis: We use current international standard methodology for the development and reporting of this COS. Its development consists of three phases: (1) an update of the most recent systematic review on outcomes reported in uncomplicated paediatric appendicitis research to identify additional outcomes, (2) a three-step global Delphi study to identify a set of core outcomes for which there is consensus between parents and (paediatric) surgeons and (3) an expert meeting to finalise the COS and its definitions. Children and young people will be involved through their parents during phase 2 and will be engaged directly using a customised face-to-face approach.

Ethics And Dissemination: The medical research ethics committee of the Academic Medical Center Amsterdam has approved the study. Each participating country/research group will ascertain ethics board approval. Electronic informed consent will be obtained from all participants. Results will be presented in peer-reviewed academic journals and at (international) conferences.

Trial Registration Number: COMET registration: 1119.
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http://dx.doi.org/10.1136/bmjopen-2018-028861DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6538019PMC
May 2019

Health economics and quality of life in a feasibility RCT of paediatric acute appendicitis: a protocol study.

BMJ Paediatr Open 2018 21;2(1):e000347. Epub 2018 Sep 21.

Department of Paediatric Surgery and Urology, Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK.

Background: Acute appendicitis is one of the most common acute surgical emergencies in children and accounts for an annual cost of approximately £50 million to the National Health Service. Investigating alternative treatment options offers the best prospect of enhancing the quality of care for patients and potential opportunities for cost savings through better allocative efficiency. A feasibility randomised controlled trial (RCT) comparing a non-operative treatment pathway with appendicectomy for children with acute uncomplicated appendicitis is underway (CONTRACT feasibility RCT).

Aims: The prime objective of this economic substudy conducted alongside the CONTRACT feasibility RCT is to better understand and assess: (1) cost data collection tools and cost drivers by identifying patients' pathways and (2) patient quality of life by assessing alternative paediatric health-related quality of life (HRQoL) instruments. Outcomes from this study will inform a future efficacy RCT assessing the effectiveness and cost-effectiveness of non-operative treatment pathway for the treatment of acute uncomplicated appendicitis in children.

Methods: The economic substudy will use individual-level data and will be conducted from the health system perspective over the study's 6-month follow-up period. Microcosting will include health resource and service use, while potential benefits acquired will be measured using the HRQoL measures, Child Health Utility 9D (CHU-9D) and Euroqol-5 dimensions and 5 levels (EQ-5D-5L). We will assess the appropriateness of using the cost per quality-adjusted life year framework in the future RCT, as well as testing and identifying the most suitable HRQoL instrument.

Conclusions: The outcomes of the investigational economic substudy will be used to inform the design of our future definitive RCT. However, the result from this economic study will also provide a detailed description and account of the issues inherent in paediatric Economic Evaluations Alongside Clinical Trials with an emphasis on costing methods of interventions taking place in secondary care settings.

Trial Registration Number: ISRCTN1583043.
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http://dx.doi.org/10.1136/bmjpo-2018-000347DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6157565PMC
September 2018

European Paediatric Surgeons' Association Survey on the Management of Pediatric Appendicitis.

Eur J Pediatr Surg 2019 Feb 15;29(1):53-61. Epub 2018 Aug 15.

Division of General and Thoracic Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada.

Aim:  To define patterns in the management of pediatric appendicitis.

Methods:  A total of 169 delegates from 42 (24 European) countries completed a validated survey administered at the EUPSA 2017 annual congress.

Results:  In the work-up of children with suspected acute appendicitis, most surgeons rely on full blood count (92%), C-reactive protein (82%), and abdominal ultrasonography (76%), but rarely on computed tomography scans or magnetic resonance imaging. In suspected simple appendicitis, most surgeons (76%) do not perform appendectomy at night in clinically stable patients and start antibiotic preoperatively (64%), but only 15% offer antibiotic therapy alone (no appendectomy). In suspected perforated appendicitis, 96% start antibiotic preoperatively, and 92% perform an appendectomy. Presence of phlegmon/abscess is the main contraindication to immediate surgery. In case of appendix mass, most responders (75%) favor a conservative approach and perform interval appendectomy always (56%) or in selected cases (38%) between 2 and 6 months from the first episode (81%). Children with large intraperitoneal abscesses are managed by percutaneous drainage (59% responders) and by surgery (37% responders). Laparoscopy is the preferred surgical approach for both simple (89%) and perforated appendicitis (81%). Most surgeons send the appendix for histology (96%) and pus for microbiology, if present (78%). At the end of the operation, 58% irrigate the abdominal cavity only if contaminated using saline solution (93%). In selected cases, 52% leave a drain in situ.

Conclusion:  Some aspects of appendicitis management lack consensus, particularly appendix mass and intraperitoneal abscess. Evidence-based guidelines should be developed, which may help standardize care and improve clinical outcomes.
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http://dx.doi.org/10.1055/s-0038-1668139DOI Listing
February 2019

Esophageal replacement by gastric transposition: A single surgeon's experience from a tertiary pediatric surgical center.

J Pediatr Surg 2018 Nov 2;53(11):2331-2335. Epub 2018 Jun 2.

Department of Paediatric Surgery and Urology, University Hospitals Southampton NHS Foundation Trust.

Background: Many pediatric surgeons have limited experience of esophageal replacement. This study reports outcomes of esophageal replacement by gastric transposition performed by a single UK-based pediatric surgeon.

Methods: Consecutive patients were identified who underwent esophageal replacement by gastric transposition over a 28 year period. Clinical and demographic data were collected. Weight-for-age Z-scores were calculated for esophageal atresia patients.

Results: Nineteen patients were identified. Indication in the majority was long-gap esophageal atresia (n = 17; 10 with tracheoesophageal fistula). At surgery, median age was 8.5 months (range 2-55); median weight was 7.4 kg (range 4.0-17.4 kg). A right-sided thoracotomy or transhiatal approach was used. Median postoperative length of stay was 17.5 days (range 7-130); median intensive care stay was three days (range 1-63). There were no deaths. Anastomotic leak rate at 30 days was 10.5% (n = 2). One patient required early stricture dilatation. Median weight-for-age Z-score increased from -2.17 at one year of age to -1.86, -1.70 and -1.93 at 5, 10 and 15 years.

Conclusions: Esophageal replacement by gastric transposition offers a potentially life-changing treatment; however, it is associated with significant morbidity. The majority of patients eventually achieve full oral feeding and maintenance of weight gain trajectory. A right-sided approach to the esophagus is feasible.

Type Of Study: Treatment Study.

Level Of Evidence: IV.
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http://dx.doi.org/10.1016/j.jpedsurg.2018.05.021DOI Listing
November 2018

The development of a consensus-based nutritional pathway for infants with CHD before surgery using a modified Delphi process.

Cardiol Young 2018 Jul 29;28(7):938-948. Epub 2018 Apr 29.

7Faculty of Health Sciences,University of Southampton,Southampton,UK.

IntroductionDespite improvements in the medical and surgical management of infants with CHD, growth failure before surgery in many infants continues to be a significant concern. A nutritional pathway was developed, the aim of which was to provide a structured approach to nutritional care for infants with CHD awaiting surgery.Materials and methodsThe modified Delphi process was development of a nutritional pathway; initial stakeholder meeting to finalise draft guidelines and develop questions; round 1 anonymous online survey; round 2 online survey; regional cardiac conference and pathway revision; and final expert meeting and pathway finalisation.

Results: Paediatric Dietitians from all 11 of the paediatric cardiology surgical centres in the United Kingdom contributed to the guideline development. In all, 33% of participants had 9 or more years of experience working with infants with CHD. By the end of rounds 1 and 2, 76 and 96% of participants, respectively, were in agreement with the statements. Three statements where consensus was not achieved by the end of round 2 were discussed and agreed at the final expert group meeting.

Conclusions: Nutrition guidelines were developed for infants with CHD awaiting surgery, using a modified Delphi process, incorporating the best available evidence and expert opinion with regard to nutritional support in this group.
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http://dx.doi.org/10.1017/S1047951118000549DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5977758PMC
July 2018

Nutritional role of amniotic fluid: clues from infants with congenital obstruction of the digestive tract.

Arch Dis Child Fetal Neonatal Ed 2019 Mar 17;104(2):F199-F201. Epub 2018 Apr 17.

Department of Paediatric Surgery and Urology, Southampton General Hospital, University of Southampton, Southampton, UK.

Aims: To investigate the role played by amniotic fluid in late fetal nutrition by analysis of infants born with digestive tract atresia.

Methods: Birth weight (BW), gestational age and gender of infants born with oesophageal (OA), duodenal (DA), jejunal (JA) and ileal atresia (IA) were recorded and BW Z-scores compared. Infants with incomplete obstruction (stenosis), chromosomal or syndromic conditions and multiple congenital malformations were excluded. Term infants admitted with suspected postnatal intestinal obstruction in whom no congenital malformation was found were used as a control group.

Results: A total of 584 infants were identified comprising 148 OA, 60 DA, 26 JA and 57 IA with 293 in the control group. Infants with OA and DA had statistically significantly lower BW Z-score than controls. However, BW Z-score for infants with more distal atresia (JA and IA) was similar to controls. When compared with infants with OA, BW Z-score for infants with more distal atresia was higher than that for OA. BW Z-score in infants with OA was significantly lower in those born at term compared with those born preterm (mean±SD -0.92±1.0 vs -0.48±0.87; p=0.01) with a significant negative correlation between BW Z-score and increasing gestational age (R=0.12; p<0.0001). This effect of gestational age was not seen in other atresias.

Conclusion: These observations support the concept that reduced enteral absorption of amniotic fluid due to high digestive tract obstruction in utero reduces fetal growth. The effect is greater when the obstruction is more proximal and with advancing gestation.
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http://dx.doi.org/10.1136/archdischild-2017-314531DOI Listing
March 2019

Development of a core outcome set to determine the overall treatment success of acute uncomplicated appendicitis in children: a study protocol.

BMJ Paediatr Open 2017 11;1(1):e000151. Epub 2017 Aug 11.

University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK.

Introduction: In recent years, there has been growing interest in alternatives to appendicectomy. In particular, non-operative treatment of appendicitis, with antibiotics alone, has been proposed as a potential treatment. A small number of randomised controlled trials (RCTs) in adults and, more recently, children suggest that antibiotic treatment may be a valid alternative to appendicectomy. However, there is currently insufficient data to justify its widespread use. Prior to performing further efficacy studies of the treatment of appendicitis in children, it is imperative to identify the most relevant outcome measures for inclusion in the design of comparative studies. This is of particular importance when evaluating a novel treatment approach since the outcomes of importance may differ from those commonly reported with traditional therapies.A review of the relevant literature and electronic resources failed to identify a core outcome set (COS) for children with appendicitis. We aim to define a COS for the measurement of treatment interventions in children (<18 years) with acute appendicitis.

Methods And Analysis: This project will entail: (1) a systematic review to identify previously reported acute uncomplicated appendicitis treatment outcomes; (2) assembly of stakeholder panels (paediatric and adult surgeons, patients and parents); (3) a three-stage Delphi process; and (4) a final consensus meeting to complete the COS.

Ethics And Registration: COS development is part of CONservative TReatment of Appendicitis in Children - a randomised controlled Trial (Feasibility) (CONTRACT) study, for which full ethical approval for CONTRACT has been granted. The COS development study is registered with the COMET Initiative in May 2017 (http://www.comet-initiative.org/studies/details/987).
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http://dx.doi.org/10.1136/bmjpo-2017-000151DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5862231PMC
August 2017

Probiotics for the prevention of surgical necrotising enterocolitis: systematic review and meta-analysis.

BMJ Paediatr Open 2017 1;1(1):e000066. Epub 2017 Nov 1.

UCL Great Ormond Street Institute of Child Health and Great Ormond Street Hospital for Children NHS Trust, London, UK.

Aim Of The Study: Probiotic administration to preterm infants has the potential to prevent necrotising enterocolitis (NEC). Data from randomised controlled trials (RCT) are conflicting but meta-analyses seem to support this intervention. To date, these analyses have not focused on surgical NEC. We aimed to determine the effect of probiotic administration to preterm infants on prevention of surgical NEC.

Methods: A systematic review of RCTs of probiotic administration to preterm infants was performed. Studies were included if RCT outcomes included any of (1) Bell's stage 3 NEC; (2) surgery for NEC; and (3) deaths attributable to NEC. Article selection and data extraction were performed independently by two authors; conflicts were adjudicated by a third author. Data were meta-analysed using Review Manager V.5.3. A random effects model was decided on a priori because of the heterogeneity of study design; data are risk ratio (RR) with 95% CI.

Main Results: Thirty-five RCTs reported NEC as an outcome. Seventeen reported surgical NEC; all RCTs were included. A variety of probiotic products was administered across studies. Description of surgical NEC in most studies was poor. Only 6/16 specifically reported incidence of surgery for NEC, 12/17 Bell's stage 3 and 13/17 NEC-associated mortality. Although there was a trend towards probiotic administration reducing stage 3 NEC, this was not significant (RR 0.74 (0.52-1.05), p=0.09). There was no effect of probiotics on the RR of surgery for NEC (RR 0.84 (0.56-1.25), p=0.38). Probiotics did, however, reduce the risk of NEC-associated mortality (RR 0.56 (0.34-0.93), p=0.03).

Conclusion: Despite 35 RCTs on probiotic prevention of NEC, evidence for prevention of surgical NEC is not strong, partly due to poor reporting. In studies included in this meta-analysis, probiotic administration was associated with a reduction in NEC-related mortality.
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http://dx.doi.org/10.1136/bmjpo-2017-000066DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5862194PMC
November 2017

Appendectomy versus non-operative treatment for acute uncomplicated appendicitis in children: study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial.

BMJ Paediatr Open 2017 18;1(1). Epub 2017 May 18.

Division of Thoracic and General Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada.

Background: Appendectomy is considered the gold standard treatment for acute appendicitis. Recently the need for surgery has been challenged in both adults and children. In children there is growing clinician, patient and parental interest in non-operative treatment of acute appendicitis with antibiotics as opposed to surgery. To date no multicentre randomised controlled trials that are appropriately powered to determine efficacy of non-operative treatment (antibiotics) for acute appendicitis in children compared with surgery (appendectomy) have been performed.

Methods: Multicentre, international, randomised controlled trial with a non-inferiority design. Children (age 5-16 years) with a clinical and/or radiological diagnosis of acute uncomplicated appendicitis will be randomised (1:1 ratio) to receive either laparoscopic appendectomy or treatment with intravenous (minimum 12 hours) followed by oral antibiotics (total course 10 days). Allocation to groups will be stratified by gender, duration of symptoms (> or <48 hours) and centre. Children in both treatment groups will follow a standardised treatment pathway. Primary outcome is treatment failure defined as additional intervention related to appendicitis requiring general anaesthesia within 1 year of randomisation (including recurrent appendicitis) or negative appendectomy. Important secondary outcomes will be reported and a cost-effectiveness analysis will be performed. The primary outcome will be analysed on a non-inferiority basis using a 20% non-inferiority margin. Planned sample size is 978 children.

Discussion: The APPY trial will be the first multicentre randomised trial comparing non-operative treatment with appendectomy for acute uncomplicated appendicitis in children. The results of this trial have the potential to revolutionise the treatment of this common gastrointestinal emergency. The randomised design will limit the effect of bias on outcomes seen in other studies.

Trial Registration Number: clinicaltrials.gov: NCT02687464. Registered on Jan 13th 2016.
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http://dx.doi.org/10.1136/bmjpo-2017-000028DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5843002PMC
May 2017
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