Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • not use any prophylactic antimicrobials
  • use prophylactic antimicrobials

Treatment groups

500 Participants
are divided into 2 treatment groups