NCT06741917

Retrograde Intrarenal Surgery Low Risk Trial

Comparison of the Post-operative Infection by Using Different Type Prophylactic Antibiotics in Low Risk Patients Who Underwent Retrograde Intrarenal Surgery

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study focuses on flexible ureteroscopic lithotripsy, a procedure commonly used to treat kidney stones and stones in the upper part of the ureter. This surgery is popular because it is minimally invasive and considered very safe. However, there is no clear agreement on whether or which antibiotics should be given to patients before the surgery to prevent infections. Taiwan is one of the regions in the world with a high rate of urinary tract stones, and because of this, it is especially important to ensure that the best practices are followed to prevent infections during and after the surgery. Currently, there are no official guidelines in Taiwan on which antibiotics should be used before flexible ureteroscopic lithotripsy. This study aims to compare different types of single-dose antibiotics given before the surgery to see if one is more effective than others in preventing infections. By looking at how different antibiotics perform, the study hopes to provide clearer guidance for doctors in choosing the best antibiotic treatment for patients, ultimately improving patient care and reducing the risk of infections after surgery.

Conditions

• Retrograde Intrarenal Surgery
• Renal Stones

Interventions

Type	Name	Description
DRUG	Levofloxacin	single dose of oral Levofloxacin (500mg/tab) before retrograde intrarenal surgery
DRUG	Cefmetazole (drug)	single dose of intravenous Cefmetazole (1000 mg)before retrograde intrarenal surgery

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-12-19
• Last updated: 2024-12-19

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study