on-operative treatment of children with appendicitis vs appendectomy

Not Applicable

Active, not recruiting

• Conditions: Appendicitis; Digestive System; Unspecified appendicitis

• Registration Number: ISRCTN16720026
• Lead Sponsor: niversity Hospital Southampton NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-28
• Last Update Posted: 26 August 2024
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 376

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.