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

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 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.