Actively Recruiting
An International Multicenter Study on Antimicrobial Prophylaxis Strategies for Flexible Ureteroscopic Lithotripsy 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
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate if not using antimicrobial prophylaxis is as effective as the traditional single-dose antimicrobial prophylaxis in patients at low risk of infection undergoing single-use flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. This international, multicenter, randomized controlled trial investigates infection prevention strategies in urological surgery, focusing on patients with stones up to 2 cm in size and no infection symptoms. Participants will be randomly assigned to one of two groups: one group will not receive any prophylactic antimicrobials before surgery and will only get antibiotics if signs of infection develop afterward. The other group will receive a single intravenous dose of antimicrobial prophylaxis 30-60 minutes before surgery, such as a second-generation cephalosporin or levofloxacin, followed by the same standardized surgical procedure using a flexible negative-pressure sheath. The surgery will use specific sheath sizes and controlled irrigation to maintain low intrarenal pressure with simultaneous stone fragmentation and suction. During the study, patients will undergo surgery performed by experienced surgeons following strict protocols. Researchers will monitor the incidence of Systemic Inflammatory Response Syndrome (SIRS) within 72 hours after surgery as the primary outcome. Data on surgical parameters and patient outcomes will be collected, and participants will be followed closely for signs of infection and recovery. The study is expected to last until December 2027, with participants aged 18 to 75 years included.
CONDITIONS
Brief Title
Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Diagnosed with renal and/or upper ureteral stones by CT, with the longest stone diameter 2 cm or less
- Scheduled to undergo flexible ureteroscopic lithotripsy (fURS)
- No preoperative infection symptoms like chills or fever
- Negative urine culture before surgery
- No immunosuppressive conditions or urinary flow obstruction from anatomical abnormalities
- No use of long-acting antimicrobials within 7 days or intermediate/short-acting antimicrobials within 72 hours prior to surgery
- Signed informed consent indicating understanding and agreement to participate
You will not qualify if you...
- Pregnant or breastfeeding women
- Allergy to study drugs
- Participation in another clinical trial within 30 days
- Active infections needing antimicrobial treatment elsewhere
- Severe systemic diseases such as heart or lung disease, cancer, or immunodeficiency
- Congenital urinary tract malformations
- History of kidney transplant or urinary diversion surgery
- Unable to provide samples or complete follow-up
- Unable or unwilling 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 fever related to stones
- Long-term urinary drainage tube
- Urine white blood cells over 5/HPF or positive urine nitrites
- Large stone burden like staghorn calculus or moderate to severe hydronephrosis
- Imaging indicating turbid urine in the renal pelvis where infection or infectious stones cannot be ruled out
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo flexible ureteroscopic lithotripsy combined with a flexible negative-pressure suction sheath. Participants in the control group receive a single dose of intravenous prophylactic antimicrobials 30-60 minutes before surgery. Participants in the experimental group have surgery without prophylactic antimicrobials and receive therapeutic antimicrobials only if infection signs develop postoperatively.
1 surgical visit (in-person)
Duration - Up to 72 hours postoperatively
Participants are monitored for infection and other outcomes for up to 72 hours after surgery.
Approximately 1 to 2 visits within 72 hours after surgery
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
Z
Ziyang Zheng
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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