Appendicitis Digestive System Unspecified appendicitis
Conditions
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
4 Years to 15 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success, defined as recovery from acute appendicitis and having none of the following: negative appendicectomy, complication requiring intervention under general anaesthesia, failure of non-operative treatment during initial hospital admission (treated with appendicectomy), recurrent appendicitis. Measured at 1 year following randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Negative appendicectomy recorded by research nurse at hospital discharge, 6 weeks 2. Intra-abdominal abscess recorded by research nurse at hospital discharge, 6 weeks 3. Reoperation recorded by research nurse at hospital discharge, 6 weeks, 4, 8, 12 months 4. Bowel obstruction recorded by research nurse at hospital discharge, 6 weeks, 4, 8, 12 months 5. Wound infection recorded by research nurse at hospital discharge, 6-week review 6. Other wound complication recorded by research nurse at hospital discharge, 6-week review 7. Antibiotic failure recorded by research nurse at hospital discharge, 6-week review 8. Length of hospital stay recorded by research nurse at hospital discharge, 6 weeks, 4, 8, 12 months 9. Histology of appendix recorded by research nurse at hospital discharge, 6 weeks, 4, 8, 12 months 10. Adverse events recorded by research nurse at hospital discharge, 6 weeks, 4, 8, 12 months 11. Recurrent appendicitis recorded by research nurse at 6 weeks and 4, 8, 12 months 12. Readmission to hospital recorded by research nurse at 6 weeks and 4, 8, 12 months 13. Patient’s quality of life measured using Child Health Utility (CHU9D) by smartphone app and research nurse at hospital discharge, 1, 2, 3, 4, 6 weeks and 4, 8, 12 months 14. Healthcare resource use recorded using shortened Client Service Receipt Inventory (CSRI) by research nurse at 6 weeks and 4, 8, 12 months 15. Death recorded by research nurse at hospital discharge, 6 weeks, 4, 8, 12 months 16. Was pain relief taken? (Y/N) recorded by smartphone app daily for 3 weeks following discharge 17. Able to do normal daily activities (Y/N) recorded by smartphone app daily for 3 weeks following discharge 18. Attended school (Y/N) recorded by smartphone app daily for 3 weeks following discharge 19. Able to do full activities (Y/N) recorded by smartphone app daily for 3 weeks following discharge 20. Parents missed work (Y/N) recorded by research nurse and smartphone app at hospital discharge and daily for 3 | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactJessica Kelly
Outcome results
None listed