CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

Autor: Hutchings N; Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK., Wood W; National Institute of Health Research (NIHR), Research Design Service South Central, University of Southampton, Southampton, UK., Reading I; Primary Care and Population Sciences, Faculty of Medicine, University of Southampton, Southampton, UK., Walker E; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Blazeby JM; Centre for Surgical Research, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK., Van't Hoff W; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK., Young B; Institute of Psychology, Health & Society, University of Liverpool, Liverpool, UK., Crawley EM; Centre for Child and Adolescent Health, School of Social and Community Medicine, University of Bristol, Bristol, UK., Eaton S; UCL Great Ormond Street Institute of Child Health, London, UK., Chorozoglou M; Southampton Health Technology Assessment Centre, Faculty of Medicine, University of Southampton, Southampton, UK., Sherratt FC; Institute of Psychology, Health & Society, University of Liverpool, Liverpool, UK., Beasant L; Centre for Child and Adolescent Health, School of Social and Community Medicine, University of Bristol, Bristol, UK., Corbett H; Department of Paediatric Surgery, Alder Hey Children's NHS Foundation Trust, East Prescott Road, Liverpool, L14 5AB, UK., Stanton MP; Department of Paediatric Surgery and Urology, Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK., Grist S; Patient and Public Involvement Representative, Southampton, UK., Dixon E; Southampton Clinical Trials Unit, Faculty of Medicine, University of Southampton, Southampton, UK., Hall NJ; Department of Paediatric Surgery and Urology, Southampton Children's Hospital, University Hospital Southampton NHS Foundation Trust, Southampton, UK. n.j.hall@soton.ac.uk.; University Surgery Unit, Faculty of Medicine, University of Southampton, Mailpoint 816, Tremona Road, Southampton, SO16 6YD, UK. n.j.hall@soton.ac.uk.
Jazyk: angličtina
Zdroj: Trials [Trials] 2018 Mar 02; Vol. 19 (1), pp. 153. Date of Electronic Publication: 2018 Mar 02.
DOI: 10.1186/s13063-018-2520-z
Abstrakt: Background: Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial.
Methods/design: The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery.
Discussion: In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design.
Trial Registration: ISRCTN15830435 . Registered on 8 February 2017.
Databáze: MEDLINE
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