NCT02795793

Non-operative Management for Appendicitis in Children

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Sydney Children's Hospitals Network · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Acute Focal Appendicitis
• Appendicitis

Interventions

Type	Name	Description
DRUG	Non-operative management group (NOM)	With intravenous Piperacillin with Tazobactam (Tazocin)
PROCEDURE	Appendectomy group (Operative management, OM)

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-05-01
• Completion: 2019-12-01
• First posted: 2016-06-10
• Last updated: 2018-09-18

Locations

2 sites across 1 country: Australia