NCT07355907

Preoperative Prophylactic Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Postpercutaneous Nephrolithotomy Infectious Complications and Sepsis.

Comparison of Preoperative Prophylactic Single Dose Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Post-percutaneous Nephrolithotomy Infectious Complications and Sepsis: A Prospective Randomized Controlled Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Tanta University · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial comparing the use of preoperative prophylactic single dose fosfomycin trometamol versus levofloxacin in prevention of post-PCNL infectious complications and sepsis. the 3 groups were compared as regards the baseline data, preoperative data, intra-operative data, and post-op data.

Detailed description

A prospective randomized study, in which 300 patients admitted to urology department, Tanta university with renal stones prepared for PCNL were randomly distributed into 3 groups: Group I, included 70 patients received single oral dose Fosfomycin 3 gm the night before the procedure. Group II, included 70 patients received 5 days levofloxacin 500 mg once daily before PCNL Group III, included 70 patients will not receive preoperative treatment The patients were evaluated by: complete hemogram, renal function, stone work-up, and MSU culture were done preoperatively. NCCT was done for all included patients Intraoperative renal pelvic urine (collected after ureteral catheterization or at first puncture of pelvicalyceal system \[PCS\]) and stone fragments were collected in sterile plastic containers for culture. The samples were sent immediately (within 1 hour) to the laboratory for processing. The following data were recorded and compared; patients' demographic data, stone characteristics, preoperative lab. Investigations, intraoperative data (OR time and complications) and postoperative data (SFR, complications especially infectious ones, sepsis and fever, hospital stay), and post-operative bacteruria.

Conditions

• Calculi, Renal
• PCNL
• Infectious Complications

Interventions

Type	Name	Description
PROCEDURE	PCNL	PCNL for renal stones

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-07-02
• Completion: 2025-01-01
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: Egypt