Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
An International Multicenter Study on the Antimicrobial Prophylaxis Strategy for Flexible Ureteroscopic Lithotripsy Combined With a Flexible Negative Pressure Suction Sheath
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
500 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
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.
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.
Locations(1)
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NCT07246967