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

Autor:	Hall NJ; University Surgery Unit, Faculty of Medicine, University of Southampton, Southampton, UK n.j.hall@soton.ac.uk.; Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK., Eaton S; UCL Great Ormond Street Institute of Child Health, London, UK., Sherratt FC; Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, UK., Reading I; Primary Care, Population Sciences and Medical Education, Faculty of Medicine, University of Southampton, Southampton, UK., Walker E; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Chorozoglou M; Southampton Health Technology Assessment Centre, Faculty of Medicine, University of Southampton, Southampton, UK., Beasant L; Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK., Wood W; National Institute of Health Research (NIHR), Research Design Service South Central, University of Southampton, Southampton, UK., Stanton M; Department of Paediatric Surgery and Urology, Southampton Children's Hospital, Southampton, UK., Corbett H; Department of Paediatric Surgery, Alder Hey Children's NHS foundation Trust, Liverpool, UK., Rex D; Department of Paediatric Surgery, St George's University Hospitals NHS Foundation Trust, London, UK., Hutchings N; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK., Dixon E; Southampton Clinical Trials Unit, University of Southampton, Southampton, UK., Grist S; Patient and Public Involvement Representative, Southampton, UK., Crawley EM; Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK., Young B; Department of Public Health, Policy and Systems, Institute of Population Health, University of Liverpool, Liverpool, UK., Blazeby JM; Centre for Surgical Research and NIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.
Jazyk:	angličtina
Zdroj:	Archives of disease in childhood [Arch Dis Child] 2021 Jul 19; Vol. 106 (8), pp. 764-773. Date of Electronic Publication: 2021 Jul 19.
DOI:	10.1136/archdischild-2020-320746
Abstrakt:	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. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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