Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath (NCT07246967) | Clinical Trial Compass
RecruitingNot Applicable
Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
China500 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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.
✓. No immunosuppressive status and no urinary flow obstruction caused by anatomical abnormalities.
✓. 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.
✓. 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
✕. 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.
✕. Concomitant severe systemic diseases, such as cardiac or pulmonary disease, malignant tumors, and immunodeficiency states.
What they're measuring
1
the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours postoperatively
Timeframe: within 72 hours postoperatively
Trial details
NCT IDNCT07246967
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine