Non-operative Management for Appendicitis in Children

Appendicitis Clinical Trial

— APRES  

Official title:

A Prospective Randomised Controlled Non-inferiority Study to Evaluate the Effectiveness and Safety (APRES) of Non-operative Management in Children With Acute Uncomplicated Appendicitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02795793
• Other study ID #: HERC/15/SCHN/266
• Status: Recruiting
• Phase: N/A
• Start date: May 2016
• Est. completion date: December 2019

Study information

• Verified date: September 2018
• Source: Sydney Children's Hospitals Network
• Contact: Susan Adams, MBBS
• Phone: 61 02 9382 1776
• Email: susan.adams[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Appendicectomy for acute appendicitis is one of the most commonly performed paediatric emergency operations in Australia. This standard treatment of acute uncomplicated appendicitis (AUA) has remained largely unchallenged since its introduction in the late nineteenth century, under the assumption that AUA progresses to perforation and thus complications should an operation be withheld. However, appendicectomy via laparoscopic or open approach is not without its risks.

Non-operative management (NOM) with antibiotics has been increasingly accepted as mainstay therapy for many intra-abdominal infections. In fact, children with appendicitis complicated by perforation, abscess or phlegmon formation are often preferentially treated non-operatively with antibiotic therapy, with or without percutaneous drainage. Systematic reviews and meta-analyses have demonstrated that antibiotics are a safe and effective treatment for AUA in adults and there is growing evidence that NOM is safe and effective in children.

Primary objectives:

To determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed likely AUA in children.

Secondary objectives:

1. To compare the safety and efficacy of NOM of clinically diagnosed likely AUA with operative management (OM) in children.

2. To assess the cost-effectiveness of NOM of clinically diagnosed likely AUA against OM in children.

3. To assess the feasibility and acceptability of NOM of appendicitis in children.

This study will enrol 226 patients, age 5-16 years, with acute uncomplicated appendicitis at two tertiary children's hospitals. Allocation ratio of 1:1 will be made via weighted minimisation using the following criteria: age (5-8 years or 9-16 years), gender (male or female), and duration of symptoms (<48 or >48 hours).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 226
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Focal Appendicitis
• Appendicitis

Intervention

Drug:
• Non-operative management group (NOM)
With intravenous Piperacillin with Tazobactam (Tazocin)

Procedure:
• Appendectomy group (Operative management, OM)

Locations

Country	Name	City	State
Australia	Sydney Children's Hospital	Randwick	New South Wales
Australia	The Children's Hospital at Westmead	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Sydney Children's Hospitals Network

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unplanned or unnecessary operation(s) and complications		30 days
Secondary	Unplanned or unnecessary operation, or complications		6 months
Secondary	Length of primary hospital stay	Time of randomisation to discharge	72 hours
Secondary	Treatment-related complications		12 months
Secondary	Redamission and Emergency Department presentation		12 months
Secondary	Cost of treatment in Australian Dollars (AUD)		12 months
Secondary	Return to school from time of randomisation		30 days
Secondary	Return to normal activities from time of randomisation		30 days