UnknownNot Applicable

Non-operative Management for Appendicitis in Children

Australia226 participantsStarted 2016-05

Plain-language 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.

Who can participate

Age range5 Years – 16 Years

SexALL

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Inclusion criteria

✓. Age between 5 and 15 years;
✓. 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

✕. 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;
✕. Previous non-operative treatment of acute appendicitis;
✕. Age younger than 5 years or older than 16 years;
✕. Known intolerance or allergy to Piperacillin with Tazobactam;
✕. Known history of inflammatory bowel disease, or other chronic abdominal pain syndrome;
✕. Known concurrent significant illness;
✕. Unable to obtain informed consent from parents or guardian;
✕. Known to have a cognitive impairment, an intellectual disability or a mental illness that would impair participation.

What they're measuring

Unplanned or unnecessary operation(s) and complications

Timeframe: 30 days

Trial details

NCT IDNCT02795793

SponsorSydney Children's Hospitals Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05

Contact for this trial

Susan Adams, MBBS

61 02 9382 1776 susan.adams@unsw.edu.au

View on ClinicalTrials.gov More Acute Focal Appendicitis trials