Actively Recruiting
Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-04-23
500
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed with renal and/or upper ureteral stones by CT, with longest stone diameter 2 cm or less
- Scheduled for flexible ureteroscopic lithotripsy
- No preoperative infection symptoms such as chills or fever
- Negative urine culture before surgery
- No immunosuppressive conditions or urinary flow obstruction due to anatomical abnormalities
- No use of long-acting antibiotics within 7 days before surgery
- No use of intermediate or short-acting antibiotics within 72 hours before surgery
- Signed informed consent form agreeing to participate
You will not qualify if you...
- Pregnant or lactating women
- Allergy to study drugs
- Participation in other clinical trials within 30 days
- Presence of other active infections needing antibiotics
- Severe systemic diseases like heart, lung diseases, cancer, or immunodeficiency
- Congenital urinary tract malformations
- History of kidney transplant or urinary diversion surgery
- Unable to provide samples or complete follow-up as required
- Unable to give informed consent
- Inability to place the flexible negative-pressure suction sheath fully
- Any condition deemed unsuitable by the investigator
- History of diabetes or immunocompromised status
- Renal insufficiency or neurogenic bladder
- Recent stone-related fever before surgery
- Long-term indwelling urinary catheter
- Urine white blood cells more than 5 per high power field or positive urine nitrites
- Large stone burden such as staghorn calculi or moderate to severe hydronephrosis
- Imaging showing turbid urine in the renal pelvis where infection cannot be excluded
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
Z
Ziyang Zheng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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