CONservative TReatment of Appendicitis in Children: A randomised controlled feasibility Trial (CONTRACT)
Archives of Diseases in Childhood Jan 16, 2021
Hall NJ, Eaton S, Sherratt FC, et al. - Researchers aimed at determining the feasibility of a multicentre randomized controlled trial examining the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy in children with uncomplicated acute appendicitis. In order to inform recruiter training to optimise recruitment and the design of a future definitive trial, they conducted feasibility randomized controlled trial with embedded qualitative study. Of eligible participants (95% CI 40 to 59) approached about the trial, 50% agreed to participate and were randomized. Over the course of the trial, an increase in recruitment rate from 38% to 72% was observed in correlation with repeated bespoke recruiter training. Randomization was highly acceptable with good patient and surgeon adherence to trial procedures and satisfactory completion of follow-up. Despite perforated appendicitis in more participants than had been anticipated, treatment pathways were identified as safe and adverse event profiles as acceptable. Observations support the feasibility of recruitment to a randomized controlled trial investigating the effectiveness and cost-effectiveness of a non-operative treatment pathway compared with appendicectomy for the treatment of uncomplicated acute appendicitis in children.
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