To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.
Adult patients aged ≥18 years;
Deemed eligible for elective hepatobiliary surgery;
Demonstrated comprehension of the study nature and expressed willingness to comply with trial procedures;
Capable of providing written informed consent.
History of β-lactam allergy or hypersensitivity
Uncontrolled preoperative infection;
Current or recent (within the preceding month) systemic corticosteroid administration;
Severe hepatic or renal impairment;
Parallel
Piperacillin-tazobactam
DrugParticipants were randomized allocated to intervention group and receive piperacillin-tazobactam as prophylactic antibiotic before hepatobiliary surgery. Participants in the cotrol group will receive cefuroxime for prophylactic antibiotic.
Number of participants with surgical site infection within 30 days after surgery
The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
30-day mortality
Number of Participants with Sepsis within 30 days after surgery
Sepsis was defined according to criteria of the third international consensus of sepsis (doi: 10.1001/jama.2016.0287).
Number of Participants with Postoperative bile leak or pancreas fisula
Postoperative bile leak and pancreas fisula was assessed by the treating surgeons.
Postoperative hospital stay
Click on the lead sponsor to view all of their trials.
