CONservative TReatment of Appendicitis in Children – a randomised controlled Trial (CONTRACT 2)
Appendicitis
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 12 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 12 months from the date of first discharge from hospital. The follow-up period involves four appointments at 6 weeks, 4, 8 and 12 months. All patients, or a member of their family, will be asked to complete questionnaires at randomisation, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 4 months, 8 months and 12 months. Patients will also be asked to complete a diary smartphone app for the 3 weeks immediately after discharge
1. Children aged 4–15 years 2. Clinical diagnosis, 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
1. Complicated appendicitis score of 4 or greater 2. Clinical or radiological findings to suggest perforated appendicitis 3. Presentation with appendix mass 4. Previous episode of appendicitis or appendix mass treated non-operatively 5. Major anaesthetic risk precluding allocation to the appendicectomy arm 6. Known antibiotic allergy preventing allocation to non-operative treatment arm 7. Positive pregnancy test