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

T

Tanta University

Status

Completed

Conditions

PCNL
Infectious Complications
Calculi, Renal

Treatments

Procedure: PCNL

Study type

Interventional

Funder types

Other

Identifiers

NCT07355907
35524/6/22

Details and patient eligibility

About

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.

Full 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.

Enrollment

210 patients

Sex

All

Ages

15 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adult patients with renal stones scheduled for PCNL

Exclusion criteria

  • Unfit patients for surgery
  • patients with active UT
  • uncorrected coagulopathy
  • pregnancy
  • children

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 3 patient groups

Preoperative Fosfomycin Trometamol group
Active Comparator group
Description:
Fosfomycin before PCNL
Treatment:
Procedure: PCNL
Preoperative 5-day Levofloxacin group
Active Comparator group
Description:
Levofloxacin before PCNL
Treatment:
Procedure: PCNL
No preopertive antibiotic group
Other group
Description:
control, no preoperative antibiotic before PCNL
Treatment:
Procedure: PCNL

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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