Non-operative Management for Appendicitis in Children

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sydney Children's Hospitals Network; Sydney Children's Network
• Treatments: Piperacillin; Tazobactam

Criteria

Inclusion Criteria:

1. Age between 5 and 15 years;

2. Clinical diagnosis by at least one paediatric surgeon (or duty surgical registrar) of acute uncomplicated appendicitis based on with a combination of clinical, laboratory and/or imaging findings; that before the study would have led to the decision to recommend been subjected to an appendicectomy.

Exclusion Criteria: if one or more of the following is assessed to be present

1. Suspicion of perforated appendicitis on the basis of generalised peritonitis and/or imaging studyA diagnosis of perforated or complicated appendicitis (e.g. peritonitis, appendiceal mass) is made on the basis of clinical, laboratory and/or imaging findings;

2. Previous non-operative treatment of acute appendicitis;

3. Age younger than 5 years or older than 16 years;

4. Known intolerance or allergy to Piperacillin with Tazobactam;

5. Known history of inflammatory bowel disease, or other chronic abdominal pain syndrome;

6. Known concurrent significant illness;

7. Unable to obtain informed consent from parents or guardian;

8. Known to have a cognitive impairment, an intellectual disability or a mental illness that would impair participation.