Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2026-01-03 @ 6:34 PM
Study NCT ID:
NCT02795793
Status:
UNKNOWN
Last Update Posted:
2018-09-18
First Post:
2016-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-operative Management for Appendicitis in Children
Sponsor:
Sydney Children's Hospitals Network
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APRES
Brief 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.
Detailed 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).
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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: