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Duration of Perioperative Antibiotics in Pancreatoduodenectomy
Sponsor: Asan Medical Center
Summary
The goal of this clinical trial is to compare two perioperative antibiotic prophylaxis regimens in adult patients undergoing pancreatoduodenectomy (PD) or pylorus-preserving pancreatoduodenectomy (PPPD). The main question it aims to answer is: Is a single preoperative dose of cefazolin non-inferior to the conventional extended regimen (preoperative cefoxitin followed by 3 days of postoperative cefotaxime plus metronidazole) in preventing surgical site infection? Researchers will compare the single-dose cefazolin regimen with the conventional extended regimen to determine whether the shorter regimen results in a comparable rate of postoperative surgical site infection. Participants will be randomized 1:1 to one of the two regimens and followed for 30 days after surgery for surgical site infection and other infectious complications.
Official title: Duration of Perioperative Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy: a Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
558
Start Date
2026-05-11
Completion Date
2028-12
Last Updated
2026-05-28
Healthy Volunteers
No
Interventions
single dose preoperative antibiotic
Arm A is a single preoperative dose of cefazolin administered within 1 hour before surgery
Prolonged perioperative antibiotics
Preoperative Single-Dose Cefoxitin followed by Three-Day Cefotaxime and Metronidazole Prophylaxis
Locations (1)
Asan Medical Center
Seoul, South Korea