CONservative TReatment of Appendicitis in Children – a randomised controlled feasibility Trial (CONTRACT)
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 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.
gastroenterology, health services research, qualitative research, therapeutics
764-773
Hall, Nigel
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Eaton, Simon
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Sherratt, Frances C.
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Reading, Isabel
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Walker, Erin
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Chorozoglou, Maria
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Beasant, Lucy
a080197b-17cd-46eb-8622-b9b85f072268
Wood, Wendy
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Stanton, Michael
eb3258f5-245b-454a-9556-9ef3d0ebb87d
Corbett, Harriet
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Rex, Dean
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Hutchings, Natalie J
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Dixon, Elizabeth
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Grist, Simon
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Crawley, Esther M.
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Young, Bridget
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Blazeby, Jane M.
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1 August 2021
Hall, Nigel
6919e8af-3890-42c1-98a7-c110791957cf
Eaton, Simon
e14103c2-c06a-45e6-87fe-2358a3371283
Sherratt, Frances C.
15d60c07-ff52-4a37-b51e-5de8b39d4624
Reading, Isabel
6f832276-87b7-4a76-a9ed-b4b3df0a3f66
Walker, Erin
7f02632a-dc68-40e5-aac6-4bf24a877e83
Chorozoglou, Maria
1d8dc56f-914a-402a-8155-4fb1e4380835
Beasant, Lucy
a080197b-17cd-46eb-8622-b9b85f072268
Wood, Wendy
c7e12f30-5332-4717-a0c8-328775e06364
Stanton, Michael
eb3258f5-245b-454a-9556-9ef3d0ebb87d
Corbett, Harriet
eebbc3a7-c4ea-4415-9e29-571fd3fb9e44
Rex, Dean
b1675a45-a338-42b7-b55d-2f86450d79f7
Hutchings, Natalie J
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Dixon, Elizabeth
f2e33dd1-36f5-4a82-8d3b-ebd5b14cb675
Grist, Simon
25cee0b2-96e4-4f86-b90b-27126477608a
Crawley, Esther M.
14939e46-323c-45ae-bb61-129edc0429ea
Young, Bridget
f950d6c8-951a-461a-bf69-5ed67bba2a73
Blazeby, Jane M.
689d490e-fca3-4430-88de-f19ec6cebf58
Hall, Nigel, Eaton, Simon, Sherratt, Frances C., Reading, Isabel, Walker, Erin, Chorozoglou, Maria, Beasant, Lucy, Wood, Wendy, Stanton, Michael, Corbett, Harriet, Rex, Dean, Hutchings, Natalie J, Dixon, Elizabeth, Grist, Simon, Crawley, Esther M., Young, Bridget and Blazeby, Jane M.
(2021)
CONservative TReatment of Appendicitis in Children – a randomised controlled feasibility Trial (CONTRACT).
Archives of Disease in Childhood, 106 (8), .
(doi:10.1136/archdischild-2020-320746).
Abstract
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.
Text
Final version CONTRACT-F paper Nov 2020
- Accepted Manuscript
More information
Accepted/In Press date: 8 December 2020
e-pub ahead of print date: 13 January 2021
Published date: 1 August 2021
Additional Information:
Funding Information:
Funding This study is part of a larger project, CONTRACT, funded by the UK National Institute for Health Research (NIHR) Health Technology Assessment programme (grant number: 14/192/90; http://www.nets.nihr.ac.uk/projects/hta/ 1419290). JMB is supported by the NIHR Bristol Biomedical Research Centre and is an NIHR Senior Investigator.
Funding Information:
8Centre for Academic Child Health, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, UK 9National Institute of Health Research (NIHR), Research Design Service South Central, University of Southampton, Southampton, UK 10Department of Paediatric Surgery, Alder Hey Children’s NHS foundation Trust, Liverpool, UK 11Department of Paediatric Surgery, St George’s University Hospitals NHS Foundation Trust, London, UK 12Southampton Clinical Trials Unit, University of Southampton, Southampton, UK 13Patient and Public Involvement Representative, Southampton, UK 14Centre for Surgical Research and NIHR Bristol Biomedical Research Centre, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK Acknowledgements SE and EW acknowledge support from NIHR Great Ormond Street Hospital Biomedical Research Centre. LB acknowledges support from the Medical Research Council ConDuCT-II Hub (Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures; MR/K025643/1).
Publisher Copyright:
©
Keywords:
gastroenterology, health services research, qualitative research, therapeutics
Identifiers
Local EPrints ID: 445987
URI: http://eprints.soton.ac.uk/id/eprint/445987
ISSN: 0003-9888
PURE UUID: 6abcd5a8-471d-4e13-931e-9eaa33b375aa
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Date deposited: 18 Jan 2021 17:31
Last modified: 17 Mar 2024 03:24
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Contributors
Author:
Simon Eaton
Author:
Frances C. Sherratt
Author:
Isabel Reading
Author:
Erin Walker
Author:
Lucy Beasant
Author:
Wendy Wood
Author:
Michael Stanton
Author:
Harriet Corbett
Author:
Dean Rex
Author:
Natalie J Hutchings
Author:
Elizabeth Dixon
Author:
Simon Grist
Author:
Esther M. Crawley
Author:
Bridget Young
Author:
Jane M. Blazeby
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