Acute Focal Appendicitis, Appendicitis
Conditions
Keywords
appendicitis, non-operative management, children, pediatric
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).
Interventions
DRUGNon-operative management group (NOM)
With intravenous Piperacillin with Tazobactam (Tazocin)
PROCEDUREAppendectomy group (Operative management, OM)
Sponsors
Sydney Children's Hospitals Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unplanned or unnecessary operation(s) and complications | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of primary hospital stay | 72 hours | Time of randomisation to discharge |
| Treatment-related complications | 12 months | — |
| Redamission and Emergency Department presentation | 12 months | — |
| Unplanned or unnecessary operation, or complications | 6 months | — |
| Return to school from time of randomisation | 30 days | — |
| Return to normal activities from time of randomisation | 30 days | — |
| Cost of treatment in Australian Dollars (AUD) | 12 months | — |
Countries
Australia
Contacts
Primary ContactSusan Adams, MBBS
Backup ContactJonathan Karpelowsky, MBBCh
Outcome results
None listed