drugset / Trial / NCT06741917

Retrograde Intrarenal Surgery Low Risk Trial

NCT06741917

Phase 4 Enrolling by invitation 200 enrolled National Taiwan University Hospital
RandomizedSingle-groupOpen-labelPrevention

Summary

In the treatment of kidney stones and upper ureteral stones, flexible ureteroscopic lithotripsy has become the mainstream choice due to its minimally invasive nature and high safety. However, there is still no universal consensus on the use of prophylactic antibiotics before surgery. Taiwan, located in the subtropical region, is one of the areas in the world with a high incidence of urinary tract stones. Currently, there are no established guidelines for the use of prophylactic antibiotics before flexible ureteroscopic lithotripsy in Taiwan. This study aims to evaluate the differences between single-dose, different types of prophylactic antibiotics in generally healthy adult patients undergoing flexible ureteroscopic lithotripsy.

Timeline

Start
2024-12-04
Primary completion
2026-06-30
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cefmetazole Small molecule 1000 mg Intravenous
Subject Levofloxacin Small molecule 500 mg Oral

Indications