A Prospective Randomised Controlled Study of Non-operative Management for Appendicitis in Childre

Not Applicable

Recruiting

• Conditions: Acute Focal Appendicitis; Appendicitis; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616000788471
• Lead Sponsor: The Sydney Children's Hospital Network

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Age between 5 and 16 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nplanned or unnecessary operation which is assessed by review of medical records and and at post-discharge telephone interviews. An unplanned or unnecessary operation is defined as operation that is not part if study protocol, occurring as a result of failure or complication of study treatment.[30 days post-randomisation]