Specialty: Children, Primary sub-specialty: Gastroenterology, Hepatology and Nutrition
Conditions
Sponsors
University Hospital Southampton NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Child age 4 – 15 years (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
Exclusion criteria
Exclusion criteria: 1. Clinical signs or radiological findings to suggest perforated appendicitis 2. Presentation with appendix mass 3. Previous episode of appendicitis or appendix mass treated non-operatively 4. Major anaesthetic risk precluding allocation to the appendicectomy arm 5. Known antibiotic allergy preventing allocation to non-operative treatment arm 6. Antibiotic treatment started at referring institution (defined as 2 or more doses administered) 7. Cystic fibrosis 8. Positive pregnancy test 9. Current treatment for malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactNatalie Hutchings
Outcome results
None listed