Non-operative Management for Appendicitis in Children (APRES)
Acute Focal Appendicitis, Appendicitis
About this trial
This is an interventional treatment trial for Acute Focal Appendicitis focused on measuring appendicitis, non-operative management, children, pediatric
Eligibility Criteria
Inclusion Criteria:
- Age between 5 and 15 years;
- 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
- 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;
- Previous non-operative treatment of acute appendicitis;
- Age younger than 5 years or older than 16 years;
- Known intolerance or allergy to Piperacillin with Tazobactam;
- Known history of inflammatory bowel disease, or other chronic abdominal pain syndrome;
- Known concurrent significant illness;
- Unable to obtain informed consent from parents or guardian;
- Known to have a cognitive impairment, an intellectual disability or a mental illness that would impair participation.
Sites / Locations
- Sydney Children's HospitalRecruiting
- The Children's Hospital at Westmead
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Non-operative management group (NOM)
Appendectomy group (Operative management, OM)
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.
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.