Urolithiasis
Conditions
Interventions
Group 1:Undergo flexible ureteroscopic lithotripsy and stone clearance with a flexible negative-pressure sheath without the use of any prophylactic antimicrobials
postoperatively, therapeutic antimicrobials will be initiated only for patients who develop signs or symptoms of infection.
Group 2:Receive 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 flexi
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years. 2.Diagnosed by CT with renal and/or upper ureteral stones, with the longest stone diameter being =2cm. 3.Scheduled to undergo fURS lithotripsy. 4.No preoperative symptoms of infection such as chills and fever, and the most recent preoperative urine culture is negative. 5.No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities. 6.No use of long-acting antimicrobial agents within 7 days prior to surgery, and no use of intermediate or short-acting antimicrobial agents within 72 hours prior to surgery. 7.Has signed and dated an informed consent form, indicating that the patient or their legal representative has been fully informed about the study-related information and has agreed to participate.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Allergy to the investigational drug(s). 3. Participation in other clinical trials within 30 days. 4. Presence of other active infection foci requiring antimicrobial treatment. 5. Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states. 6. Congenital malformations of the urinary tract. 7. History of kidney transplantation or urinary diversion surgery. 8. Unable to provide samples or complete follow-up according to the study protocol. 9. Unable to provide informed consent. 10. Inability to achieve complete placement of the flexible negative-pressure suction sheath. 11. Any other conditions that the investigator deems unsuitable for participation in this study. 12. History of diabetes mellitus, immunocompromised. 13. Renal insufficiency, neurogenic bladder. 14. Recent preoperative history of stone-related fever. 15. Long-term indwelling urinary drainage tube. 16. Urine white blood cells >5/HPF (High Power Field) or positive for urine nitrites. 17. Large stone burden (e.g., staghorn calculus) or moderate to severe hydronephrosis. 18. Imaging findings showing turbid urine in the renal pelvis where pyonephrosis or infectious stones cannot be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body temperature;Heart rate;Respiratory rate;White blood cell count; | — |
Countries
China
Contacts
Public ContactYi Shao
Shanghai General Hospital
Outcome results
None listed