International Study Comparing No Antibiotic Prophylaxis to Single-Dose Antibiotics for Flexible Ureteroscopic Lithotripsy Using a Negative Pressure Suction Sheath Evaluating Infection Prevention in Patients with Low Infection Risk and Kidney or Ureteral Stones Up to 2 cm

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.

Antibiotic Prophylaxis for Ureteroscopy With a Negative Pressure Suction Sheath