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.
- qualitative research
- health services research
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Contributors The study was conceived by NJH and SE. The protocol was developed by all coauthors. EW and SG led and supervised the PPI activity. The clinical trial was implemented by NJH, MS, HC, DR, ED, NH and JMB. The embedded qualitative research and recruiter training was designed, implemented and analysed by BY, LB, FCS and EMC. Randomisation sequence was generated and statistical analysis was performed by IR. The manuscript was written by NH, IR, FCS and critically revised by all coauthors.
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.
Disclaimer The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The overall study was given ethical approval by the Hampshire A Research Ethics Committee (ref. 16/SC/0596).
Data availability statement Data may be made available subject to reasonable request and subsequent executed data sharing agreement.
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