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Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)

RecruitingPhase 4Ages 18 Years - 90 YearsAllLeiden University Medical Center
NCT05784311 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients undergoing elective pancreatoduodenectomy with a high risk for contaminated bile defined as patients with preoperative biliary drainage or an ampullary malignancy. * Age \>18 years Exclusion Criteria: * Pregnancy * Contraindication for the study antibiotics (e.g. allergy or intolerance) * Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses) * A reduced renal function, defined as an eGFR of \<60 ml/min/1.73m2 measured on the closest timepoint prior to pancreatoduodenectomy
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What it tests

  • Cefuroxime
  • Metronidazole
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Where

11 sites
Leiden University Medical Center
Leiden, Netherlands
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Amsterdam University Medical Center
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Medisch Spectrum Twente
Enschede, Netherlands
Groningen University Medical Center
Groningen, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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