Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
Status:
Not yet recruiting
Trial end date:
2026-01-01
Target enrollment:
Participant gender:
Summary
The goal of this multicenter randomized controlled trial is to evaluate the additional value
of pre-emptive antibiotic treatment on clinically relevant organ/space surgical site
infections (OSIs) in patients undergoing pancreatoduodenectomy with a high risk for
contaminated bile. The main objectives it aims to answer are:
- To evaluate the effect of pre-emptive antibiotic prophylaxis on clinically relevant OSIs
in patients undergoing pancreatoduodenectomy with a high risk for contaminated bile
- To evaluate the effect of pre-emptive antibiotic prophylaxis on other postoperative
outcomes (e.g. OSIs, superficial SSIs, POPF, PPH, major morbidity, ICU admission,
readmission, length of hospital stay, and mortality).
- To evaluate concordance between perioperatively obtained bile cultures and postoperative
cultures from infectious sites, and to evaluate antibiotic sensitivity patterns of the
cultured microorganisms.
Participants will be randomized with a 1:1 allocation before surgery into the intervention or
control group:
- Patients in the intervention group will receive perioperative prophylaxis (similar to
the control group) followed by five days of 1500mg IV cefuroxime and 500mg IV
metronidazole thrice daily.
- Patients in the control group will only receive perioperative prophylaxis (a single dose
of 5-7mg/kg gentamicin followed by 2gr IV cefazolin and 500mg IV metronidazole every 4h
of surgery), which will be discontinued after surgery.