Effect Of Preoperative Prophylactic Antibiotic Use On Postoperative Infection After Percutaneous Nephrolithotomy In Patients With Negative Urine Culture: A Single-center Randomized Controlled Trial

Objective(s):To compare the effects of different preoperative antibiotic prophylaxis regimens on the incidence of sepsis after percutaneous nephrolithotomy(PCNL)in patients with negative urine culture.Methods:This is a single-center,randomized controlled trial scheduled to be conducted at the Second Affiliated Hospital of Kunming Medical University from June 2022 to December 2023.The study has been registered at the Chinese Clinical Trials Center(chictr.org.cn).In this study,120 patients with negative preoperative urine culture of upper urinary tract stones were included and randomly divided into experimental group and control group,with 60 patients in each group.Patients in the two groups received Levofloxacin-based preoperative antibiotic prevention program,respectively.The experimental group was no longer given prophylactic antibiotics before surgery,while the control group was given prophylactic antibiotics for 3 days before surgery.Prophylactic antibiotics expire one day after surgery.Both groups were given a dose of antibiotics within 2 hours before the start of the treatment and received percutaneous nephrolithotomy.The main findings of this study were differences in the incidence of postoperative sepsis.Results:A total of 120 subjects were included,including 60 patients in the experimental group and 60 patients in the control group.The baseline characteristics of the two groups were comparable and intraoperative characteristics also did not differ.The sepsis rate was not statistically different between the experimental and control groups(13.3%vs.13.3%,P=1.0).A multivariate logistic regression analysis revealed that body mass index(OR=1.323;95%CI=1.100-1.591;P=0.003)and operating time(OR=1.031;95%CI=1.007-1.057;P=0.012)were independent risk factors of sepsis.The white blood cell count(12.3×10~9/Lvs.10.9×10~9/L,P=0.014)and the number of white blood cells greater than 12×10~9/L(51.7%vs.25%,P=0.005)in the experimental group were significantly higher than those in the control group.Other infectious parameters and complications were no significant differences.Conclusion(s):1.For patients with negative urine culture receiving PCNL,intravenous administration of antibiotics for 3 days before surgery does not reduce the incidence of postoperative sepsis.For these patients,we suggest that a dose of antibiotics to prevent infection can be given before surgery.2.For patients with negative urine culture,although the incidence of sepsis after PCNL is low,infection indicators such as leukocyte,interleukin-6,procalcitonin and hypersensitive C-reactive protein should still be reviewed in the early postoperative period.If infection indicators continue to rise,postoperative antibiotics should be extended to further reduce the incidence of sepsis.3.For patients with high preoperative BMI and long operation time,we suggest strengthening early postoperative monitoring,because these patients are at high risk of sepsis.