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

Not Applicable

Completed

• Conditions: Specialty: Children, Primary sub-specialty: Gastroenterology, Hepatology and Nutrition; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of appendix; Digestive System; Appendicitis

• Registration Number: ISRCTN15830435
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/32228534/ qualitative study (added 27/11/2020) 2018 Protocol article in https://pubmed.ncbi.nlm.nih.gov/29499722/ protocol (added 27/11/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33441315/ results (added 18/01/2021) 2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33630732/ protocol (added 26/02/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36746524/ (added 07/02/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37286916/ (added 08/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-08
• Study Completion: 2018-10-31
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.