Every year, thousands of children in the UK are rushed to hospital with appendicitis and have their appendix surgically removed. This trial tests whether antibiotics alone—without an operation—can treat the condition just as effectively. The problem is straightforward: appendicectomy is the standard of care, but it requires general anaesthesia, a hospital stay, and recovery time. For children with uncomplicated appendicitis, non-operative treatment with antibiotics could avoid those risks and burdens. However, robust data comparing the two approaches in children are scarce. This randomised controlled trial will recruit 376 children aged 4–15 across NHS paediatric surgical units, randomly assigning them to either surgery or a course of antibiotics with regular follow-up. The primary measure is “treatment success” one year later—defined as recovery without complications, a negative appendicectomy, or recurrence. If non-operative treatment proves non-inferior, the impact on paediatric surgery could be substantial. Thousands of children each year might avoid an operation, reducing NHS costs, freeing up surgical resources, and sparing families the stress of a hospital stay. The findings will directly inform clinical guidelines and commissioning decisions across the UK.
View original technical description
BACKGROUND: Appendicitis is the most common surgical emergency in children, for which standard treatment is appendicectomy. There is great interest in non-operative treatment in children, but data comparing with appendicectomy are lacking. RESEARCH QUESTION: In children with uncomplicated acute appendicitis (Population), does non-operative treatment (Intervention) result in non-inferior clinical outcomes (Outcomes) and lower cost compared to appendicectomy (Comparator)? AIMS AND OBJECTIVES: Study aim is to assess clinical and cost effectiveness of non-operative treatment compared to appendicectomy in children with uncomplicated acute appendicitis. -primary clinical objective is to determine whether non-operative treatment is non-inferior to appendicectomy -primary health-economic objective is to conduct a full economic evaluation of these treatments -secondary objective is to compare other important patient and family centred outcomes, and cost. STUDY DESIGN: Randomised controlled trial with internal pilot. Children with uncomplicated acute appendicitis will be randomised to ‘appendicectomy’ or a ‘non-operative treatment’ pathway comprising antibiotics and regular clinical review. TARGET POPULATION: Children age 4-15 years with a diagnosis of uncomplicated acute appendicitis. SETTING: Specialist NHS Paediatric Surgical Units in the UK. MEASUREMENT OF COSTS AND OUTCOMES: The primary outcome will be ‘treatment success’ 1 year after randomisation (defined as recovery from acute appendicitis without any of the following: negative appendicectomy, complication requiring intervention under general anaesthesia, failure of non-operative treatment during initial admission, recurrent appendicitis). We will measure all applicable outcomes in our recently developed core outcome set. Health economic analysis will include a cost-effectiveness analysis centred around the primary outcome and a cost-utility analysis using HRQoL data. SAMPLE SIZE: We will test the hypothesis that non-operative treatment is non-inferior to appendicectomy. Based on the estimates of treatment success in each trial arm, a non-inferiority margin of 20% and 15% loss-to-follow up, we aim to recruit 376 participants (188 per arm). PROJECT TIMETABLES: Total duration 48 months: 6-month start-up; 12-month internal pilot at all recruiting centres; total recruitment period 2 years followed by 12 months follow-up; final analysis and dissemination (6 months). EXPERTISE IN TEAM: The team, which successfully delivered the HTA funded feasibility study on time, has experience in the design and conduct of RCTs in surgery and in children, trials methodology, surgical expertise, and statistical and health economic analysis. The study is supported by a CTU and has strong PPI involvement. IMPACT AND DISSEMINATION: This trial will provide a significant contribution to the evidence base on comparative effectiveness of non-operative treatment of appendicitis in children. Given the frequency of appendicitis in children our findings will influence care of many thousands of children. We will use traditional routes (presentation, publications) and modern alternatives including social media and webinars to disseminate our findings widely to those who participated in our study, those delivering surgical care to children, hospital managers and care commissioners. We will also target future patients and families to ensure our message is publicly available and heard.
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know