Actively Recruiting
Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
Led by Leiden University Medical Center · Updated on 2024-10-21
344
Participants Needed
11
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Standard Versus Prolonged Antibiotic Prophylaxis After Pancreatoduodenectomy (SPARROW)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Pregnancy
- Contraindication for the study antibiotics (e.g. allergy or intolerance)
- Preoperative planned therapeutic antibiotic treatment (i.e. for cholangitis or liver abscesses)
- Reduced renal function defined as an eGFR of <60 ml/min/1.73m2 measured before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA
Actively Recruiting
2
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Not Yet Recruiting
3
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
4
Amphia Ziekenhuis
Breda, Netherlands
Actively Recruiting
5
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
6
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
7
Groningen University Medical Center
Groningen, Netherlands
Actively Recruiting
8
Maastricht University Medical Center
Maastricht, Netherlands
Actively Recruiting
9
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
10
Erasmus MC Cancer Institute
Rotterdam, Netherlands
Actively Recruiting
11
Regional Academic Cancer Center Utrecht
Utrecht, Netherlands
Actively Recruiting
Research Team
D
Daphne HM Droogh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here