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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2021
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.
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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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