CONservative TReatment of Appendicitis in Children – a randomised controlled feasibility Trial (CONTRACT)

Nigel, J Hall, Simon Eaton, Frances C Sherratt, Isabel Reading, Erin Walker, Maria Chorozoglou, Lucy Beasant, Wendy Wood, Michael P. Stanton, Harriet J Corbett, Dean Rex, Natalie Hutchings, Elizabeth Dixon, Simon Grist, Esther M Crawley, Bridget Young, Jane M Blazeby

Research output: Contribution to journalArticle (Academic Journal)peer-review

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 to 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 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.

Original languageEnglish
JournalArchives of Disease in Childhood
Publication statusAccepted/In press - 8 Dec 2020

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