This study, as a prospective, randomized, controlled, non-inferiority, international multicenter clinical trial, aims to evaluate whether a strategy of no antimicrobial prophylaxis is non-inferior to the traditional single-dose prophylaxis regimen in patients with a low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. It is anticipated that this will have a substantial impact on infection prevention strategies in urological surgery.
Age 18-75 years.
Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being ≤2cm.
Scheduled to undergo fURS lithotripsy.
No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative.
Pregnant or lactating women.
Allergy to the investigational drug(s).
Participation in other clinical trials within 30 days.
Presence of other active infection foci requiring antimicrobial treatment.
Parallel
not use any prophylactic antimicrobials
DrugThe experimental group will undergo surgery without the use of any prophylactic antimicrobials; therapeutic antimicrobials will only be administered postoperatively to patients who develop signs or symptoms of infection. The control group will receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery, followed by the same standardized surgical procedure.
use prophylactic antimicrobials
DrugReceive a single dose of intravenous prophylactic antimicrobials (e.g., a second-generation cephalosporin or levofloxacin) 30-60 minutes before surgery, followed by the same standardized flexible negative-pressure sheath ureteroscopic surgery.
the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively
To reduce the influence of subjective factors and to more comprehensively reflect the systemic inflammatory state, the primary endpoint is the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively, defined as meeting at least two of the following criteria: Body temperature \>38°C or \<36°C Heart rate \>90 beats/minute Respiratory rate \>20 breaths/minute or PaCO2 \<32 mmHg White blood cell count \>12×10⁹/L or \<4×10⁹/L, or \>10% immature neutrophils
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