Hall, Nigel J, Eaton, Simon, Sherratt, Frances C 
ORCID: 0000-0003-4147-9305, Reading, Isabel, Walker, Erin, Chorozoglou, Maria, Beasant, Lucy, Wood, Wendy, Stanton, Michael, Corbett, Harriet et al (show 7 more authors)
(2021)
CONservative TReatment of Appendicitis in Children: a randomised controlled feasibility Trial (CONTRACT).
ARCHIVES OF DISEASE IN CHILDHOOD, 106 (8).
pp. 764-773.
Abstract
<h4>Objective</h4>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.<h4>Design</h4>Feasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.<h4>Setting</h4>Three specialist paediatric surgery centres in the UK.<h4>Patients</h4>Children (aged 4-15 years) with a clinical diagnosis of uncomplicated acute appendicitis.<h4>Interventions</h4>Appendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).<h4>Main outcome measures</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration number</h4>ISRCTN15830435.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | gastroenterology, health services research, qualitative research, therapeutics |
| Depositing User: | Symplectic Admin |
| Date Deposited: | 18 Jan 2021 09:22 |
| Last Modified: | 03 Feb 2024 09:36 |
| DOI: | 10.1136/archdischild-2020-320746 |
| Open Access URL: | https://adc.bmj.com/content/archdischild/early/202... |
| Related URLs: | |
| URI: | https://livrepository.liverpool.ac.uk/id/eprint/3113944 |
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