Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
After appendix has been removed for perforated appendicitis, patients will receive postoperative antibiotics. In the last 5 years, the literature has transitioned from a 3 -drug therapy to 2-drug therapy. Now there is a recent literature suggesting a single-drug therapy may be safe and adequate. In fact, using zosyn (piperacillin-tazobactam) as a single-drug therapy, there are additional benefits of simplicity, compliance, and lower infectious complications. Currently surgeons are already using both 2-drug regimen (ceftriaxone/metronidazole) and single-drug regimen (zosyn) interchangeable as both are FDA approved and regulated antibiotics for intra-abdominal infection. There is a clear need to compare outcomes between these two options.
Full description
The diagnosis of perforated appendicitis will be documented intraoperatively with photos of extraluminal fecal contents or visible holes on the appendix. Patients will be randomized to 121 in each arm. Postoperative antibiotic therapy option will be decided based on blinded sequence model. 30 day postoperative follow up visit or calls will be made to assess and collect infectious complications.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Postoperative Perforated Appendicitis (documented by intraoperative photo)
- Postoperative Laparoscopic Appendectomy
Exclusion criteria
- Nonperforated Gangrenous Appendicitis
- Nonperforated Purulent Appendicitis
- Open Appendectomy
Trial design
Primary purpose
Allocation
Interventional model
Masking
162 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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