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NCT07246967

Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath

Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: An International Multicenter Study on the Antimicrobial Prophylaxis Strategy for Flexible Ureteroscopic Lithotripsy Combined With a Flexible Negative Pressure Suction Sheath

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-02

Completion Date

2027-12

Last Updated

2026-01-21

Healthy Volunteers

Conditions

Urolithiasis Antibiotics

Interventions

DRUG

not use any prophylactic antimicrobials

The 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.

DRUG

use prophylactic antimicrobials

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 flexible negative-pressure sheath ureteroscopic surgery.

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: 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.

Locations (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, China