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 United Kingdom
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 followup, safety of treatment pathways and clinical course.
Results: Fifty percent of eligible participants (95%CI 40-59) 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 costeffectiveness of a non-operative treatment pathway compared to appendicectomy for the treatment of uncomplicated acute appendicitis in children is feasible.
|Journal||Archives of Disease in Childhood|
|Publication status||Accepted/In press - 8 Dec 2020|