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

• Published in: Archives of disease in childhood 2021-08, Vol.106 (8), p.764-773
• Main Authors: Hall, Nigel J, Eaton, Simon, Sherratt, Frances C, Reading, Isabel, Walker, Erin, Chorozoglou, Maria, Beasant, Lucy, Wood, Wendy, Stanton, Michael, Corbett, Harriet, Rex, Dean, Hutchings, Natalie, Dixon, Elizabeth, Grist, Simon, Crawley, Esther M, Young, Bridget, Blazeby, Jane M
• Format: Article
• Language: English
• Subjects: Acute Disease; Adolescent; Adverse events; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibiotics; Appendectomy - methods; Appendicitis; Appendicitis - drug therapy; Appendicitis - surgery; Appendicitis - therapy; Child; Child, Preschool; Children; Children & youth; Clinical Diagnosis; Conservative Treatment - methods; Cost Effectiveness; Cost-Benefit Analysis; Data collection; Design; Eligibility; Feasibility Studies; Female; gastroenterology; health services research; Humans; Male; Original Research; Patient care planning; Patient Selection; Patients; Pediatrics; Pragmatics; Pregnancy; Qualitative research; Recruitment; Semiotics; Surgery; therapeutics; Training; Treatment Outcome; United Kingdom
• ISSN: 0003-9888; 1468-2044; 1468-2044
• DOI: 10.1136/archdischild-2020-320746

ObjectiveTo 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.DesignFeasibility randomised controlled trial with embedded qualitative study to inform recruiter training to optimise recruitment and the design of a future definitive trial.SettingThree specialist paediatric surgery centres in the UK.PatientsChildren (aged 4–15 years) with a clinical diagnosis of uncomplicated acute appendicitis.InterventionsAppendicectomy or a non-operative treatment pathway (comprising broad-spectrum antibiotics and active observation).Main outcome measuresPrimary 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.ResultsFifty 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.ConclusionRecruitment 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 numberISRCTN15830435.