Appendicitis Perforated, Appendectomy, Laparoscopic, Antibiotic, Pediatric, Randomized Controlled Trial
Conditions
Keywords
Piperacillin, Tazobactam, Ceftriaxone, Metronidazole
Brief summary
The ALPACA-MC trial is a blinded, multicentre randomized controlled trial comparing two postoperative antibiotic treatments for children undergoing laparoscopic appendectomy for perforated appendicitis. Perforated appendicitis occurs when the appendix has developed a hole or has burst. The study will include 180 children from several pediatric hospitals. After surgery, participants will be randomly assigned to receive either piperacillin/tazobactam (PT) or ceftriaxone plus metronidazole (CM). The child, family, healthcare team, and researchers assessing the outcomes will not know which treatment was received. The main purpose of the study is to determine whether PT reduces hospital length of stay compared with CM. The study will also compare other important outcomes, including surgical site infections, the need for additional imaging or procedures, emergency department visits, and hospital readmissions. Children will be followed for 30 days after surgery. At 30 days, families will be contacted to ask about any additional complications and how well the child has recovered. This will include questions about returning to school, sports or other physical activities, and the child's overall health and quality of life. The results of this study will help determine which antibiotic treatment is most appropriate for children with perforated appendicitis and may help guide future clinical practice and antibiotic stewardship.
Interventions
DRUGPiperacillin/Tazobactam
Piperacillin/tazobactam 100 mg/kg IV q8h (to a maximum of 4.5 g IV q8h) and normal saline once daily.
Ceftriaxone 50 mg/kg IV once daily (to a maximum of 2 g IV daily) and metronidazole 10 mg/kg IV q8h (to a maximum of 500 mg IV q8h).
Sponsors
McMaster Children's Hospital
Alberta Children's Hospital
Children's Hospital, London Health Sciences Center
Montreal Children's Hospital of the MUHC
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 17 Years
Healthy volunteers
No
Inclusion criteria
* Laparoscopic appendectomy * Perforated appendicitis confirmed intra-operatively (i.e., visible hole in appendix, fecalith found in peritoneal cavity, intra-abdominal abscess, and/or purulent fluid in peritoneal cavity)
Exclusion criteria
* Non-operative treatment (e.g., due to abscess) * Interval laparoscopic appendectomy * Conversion to open procedure * Non-perforated appendicitis * Confirmed or suspected allergy to penicillins or cephalosporins * Renal impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | Measured as the number of days from index hospital admission to hospital discharge, assessed up to 30 days. | Length of stay in hospital during index admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with deep or organ-space surgical site infection | Within 30 days of surgery. | Number of participants who develop a deep incisional or organ-space surgical site infection following the index appendectomy. |
| Number of participants requiring post-operative ultrasound | Within 30 days of surgery. | Number of participants who undergo at least one abdominal ultrasound following the index appendectomy. |
| Number of participants undergoing percutaneous drain insertion | Within 30 days of surgery. | Number of participants who undergo percutaneous drain insertion by Interventional Radiology following the index appendectomy. |
| Number of participants undergoing peripherally inserted central catheter (PICC) insertion | Within 30 days of surgery. | Number of participants who undergo insertion of a peripherally inserted central catheter (PICC) following the index appendectomy. |
| Number of participants receiving parenteral nutrition | Within 30 days of surgery. | Number of participants who receive parenteral nutrition following the index appendectomy. |
| Number of participants with Clostridioides difficile infection | Within 30 days of surgery. | Number of participants who develop laboratory-confirmed Clostridioides difficile infection requiring treatment following the index appendectomy. |
| Number of participants returning to the emergency department | Within 30 days of surgery. | Number of participants who return to an emergency department following discharge from the index hospitalization for appendectomy. |
| Number of participants readmitted to hospital | Within 30 days of surgery. | Number of participants who require hospital readmission following discharge from the index hospitalization for appendectomy. |
Contacts
CONTACTMichael Livingston, MD, MSc, FRCSC
Outcome results
None listed