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CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT)
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...
Autores principales: | , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311091/ https://www.ncbi.nlm.nih.gov/pubmed/33441315 http://dx.doi.org/10.1136/archdischild-2020-320746 |
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author | Hall, Nigel J Eaton, Simon Sherratt, Frances C Reading, Isabel Walker, Erin Chorozoglou, Maria Beasant, Lucy Wood, Wendy Stanton, Michael Corbett, Harriet Rex, Dean Hutchings, Natalie Dixon, Elizabeth Grist, Simon Crawley, Esther M Young, Bridget Blazeby, Jane M |
author_facet | Hall, Nigel J Eaton, Simon Sherratt, Frances C Reading, Isabel Walker, Erin Chorozoglou, Maria Beasant, Lucy Wood, Wendy Stanton, Michael Corbett, Harriet Rex, Dean Hutchings, Natalie Dixon, Elizabeth Grist, Simon Crawley, Esther M Young, Bridget Blazeby, Jane M |
author_sort | Hall, Nigel J |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-8311091 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-83110912021-08-13 CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) Hall, Nigel J Eaton, Simon Sherratt, Frances C Reading, Isabel Walker, Erin Chorozoglou, Maria Beasant, Lucy Wood, Wendy Stanton, Michael Corbett, Harriet Rex, Dean Hutchings, Natalie Dixon, Elizabeth Grist, Simon Crawley, Esther M Young, Bridget Blazeby, Jane M Arch Dis Child Original Research 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. BMJ Publishing Group 2021-08 2021-01-13 /pmc/articles/PMC8311091/ /pubmed/33441315 http://dx.doi.org/10.1136/archdischild-2020-320746 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Original Research Hall, Nigel J Eaton, Simon Sherratt, Frances C Reading, Isabel Walker, Erin Chorozoglou, Maria Beasant, Lucy Wood, Wendy Stanton, Michael Corbett, Harriet Rex, Dean Hutchings, Natalie Dixon, Elizabeth Grist, Simon Crawley, Esther M Young, Bridget Blazeby, Jane M CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) |
title | CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) |
title_full | CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) |
title_fullStr | CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) |
title_full_unstemmed | CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) |
title_short | CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT) |
title_sort | conservative treatment of appendicitis in children: a randomised controlled feasibility trial (contract) |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311091/ https://www.ncbi.nlm.nih.gov/pubmed/33441315 http://dx.doi.org/10.1136/archdischild-2020-320746 |
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