Non operative treatment of children with appendicitis vs appendectomy – A feasibility study

INTERVENTION: Participants are randomised using an online randomisation system in a 1:1 ratio between the 2 treatment arms. Minimisation will be used for age, gender, duration of symptoms before randomisation and centre. Treatment Arm A: Non Operative Treatment Patients will be treated in hospital with a minimum of 24 hours intravenous antibiotics followed by oral antibiotics until the doctors feel they meet criteria for discharge. They will be monitored during their stay in hospital to ensure recovery and if at any stage they are deteriorating, or have not improved by 48 hours post randomisation, they will be referred for an appendicectomy. Time in hospital may vary for each patient but it is expected that the patient will be in hospital for a minimum of 48 hours. The follow up will be for 6 months from the date of first discharge from hospital. Treatment Arm B: Appendicectomy Patients will be treated with intravenous antibiotics until it is time for their operation. The operation will require a general anaesthetic to remove the appendix, either by laparoscopic or open surgery. Time in hospital may vary for each patient depending on their recovery rate. Standard care estimates the patient will be in hospital for a few days. Again, the follow up will be for 6 months from the date of first discharge from hospital. The follow up period involves 3 appointments at 6 weeks, 3 months and 6 months. All patients, or a member of their family, will be asked to complete 2 questionnaires at randomisation, discharge, 2 weeks, 6 weeks, 3 months and 6 months. Patients will also be asked to complete a diary card for the 2 weeks immediately after discharge and an extra questionnaire at the 6 weeks and 6 months follow up appointments. CONDITION: Specialty: Children, Primary sub‐specialty: Gastroenterology, Hepatology and Nutrition; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of appendix ; Digestive System ; Appendicitis PRIMARY OUTCOME: Proportion of eligible patients recruited to the study over 12 months is measured by the number of patients who consent and are randomised into the study by 12 months divided by the total number of patients who were eligible and screened for the study by 12 months. INCLUSION CRITERIA: 1. Child age 4 – 15 years (<16 years and >3 years) 2. Clinical diagnosis, either with or without radiological assessment, of acute appendicitis which prior to study commencement would be treated with appendicectomy 3. Written informed parental consent, with child assent if appropriate SECONDARY OUTCOME: 1. Willingness of parents and children to be enrolled in, and surgeons to recruit to, a randomised study comparing operative versus non‐operative treatment and identify anticipated recruitment rate ‐ measured in parallel qualitative workstream through patient/parent interviews, surgeon surveys and focus groups; 2. Identify strategies to optimise surgeon‐family communication to inform the future RCT – measured in parallel qualitative workstream during interviews with families and surgeons up to 6 months following recruitment consultation; 3. Enhance the design of a future RCT from the perspectives of stakeholders at participating sites (children, parents, surgeons and nurses) ‐ measured in parallel qualitative workstream during interviews with families, surgeons and nurses up to 6 months following recruitment consultation, in surgeon survey, and focus groups with surgeons; 4. Assess the equipoise and willingness of UK paediatric surgeons to participate in a future RCT – measured in parallel qualitative workstream with surgeon survey and focus groups; 5. Clinical outcomes of trial treatment pathways including:; 5.1. Overall success of initial non‐operative treatment (measured as the number of patients randomised to Treatment Arm A, discharged from hospital without appendicectomy); 5.2. Complications of disease and treatment (measured during hospital stay and 6 month follow‐up period); 5.3. Rate of recurrent appendicitis during 6 month follow‐up period