Non-operative Management for Appendicitis in Children (APRES)
|ClinicalTrials.gov Identifier: NCT02795793|
Recruitment Status : Unknown
Verified September 2018 by Dr Susan Adams, Sydney Children's Hospitals Network.
Recruitment status was: Recruiting
First Posted : June 10, 2016
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Focal Appendicitis Appendicitis||Drug: Non-operative management group (NOM) Procedure: Appendectomy group (Operative management, OM)||Not Applicable|
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.
To determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed likely AUA in children.
- To compare the safety and efficacy of NOM of clinically diagnosed likely AUA with operative management (OM) in children.
- To assess the cost-effectiveness of NOM of clinically diagnosed likely AUA against OM in children.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||226 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Non-operative management group (NOM)
Children in the NOM group will receive intravenous Piperacillin with Tazobactam (Tazocin) 100mg/kg/dose every 8 hours for at least 24 hours, and they will be observed and reassessed within 24 hours after randomisation. A further 24 hours of intravenous Piperacillin with Tazobactam therapy will be offered to children in invariable condition. A clinical decision will be made by the attending surgeon to offer OM if a patient's condition deteriorates at any time, or if a patient has failed to improve after 48 hours of intravenous antibiotic therapy. Once the patient is clinically improving and tolerating oral intake, the antibiotic regimen will be changed to oral Amoxicillin plus Clavulanic acid (Augmentin) 22.5mg/kg/dose twice per day to complete a total seven day course of antibiotics. Oral Ciprofloxacin 15mg/kg/dose twice daily and oral Metronidazole 10mg/kg/dose twice daily will be offered to children who are known to have an intolerance or allergy to Amoxicillin or Clavulanic acid.
Drug: Non-operative management group (NOM)
With intravenous Piperacillin with Tazobactam (Tazocin)
Active Comparator: Appendectomy group (Operative management, OM)
Children allocated to OM may receive preoperative antibiotic prophylaxis as clinically indicated. Appendicectomy will be performed laparoscopically, or via open surgery according to the surgeon's standard practice. Postoperative antibiotic treatment will be determined on the basis of intraoperative findings in accordance with the institutional practice. The appendix specimen will be examined by a paediatric pathologist, and the formal histopathology report will be recorded.
Procedure: Appendectomy group (Operative management, OM)
- Unplanned or unnecessary operation(s) and complications [ Time Frame: 30 days ]
- Unplanned or unnecessary operation, or complications [ Time Frame: 6 months ]
- Length of primary hospital stay [ Time Frame: 72 hours ]Time of randomisation to discharge
- Treatment-related complications [ Time Frame: 12 months ]
- Redamission and Emergency Department presentation [ Time Frame: 12 months ]
- Cost of treatment in Australian Dollars (AUD) [ Time Frame: 12 months ]
- Return to school from time of randomisation [ Time Frame: 30 days ]
- Return to normal activities from time of randomisation [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795793
|Contact: Susan Adams, MBBS||61 02 9382 email@example.com|
|Contact: Jonathan Karpelowsky, MBBCh||61 02 9845 firstname.lastname@example.org|
|Australia, New South Wales|
|Sydney Children's Hospital||Recruiting|
|Randwick, New South Wales, Australia, 2031|
|Contact: Susan Adams, MBBS|
|Principal Investigator: Susan Adams, MBBS|
|The Children's Hospital at Westmead||Not yet recruiting|
|Westmead, New South Wales, Australia, 2145|
|Contact: Jonathon Karpewlosky, MBBCh|
|Principal Investigator: Jonathon Karpelowsky, MBBCh|