Efficacy of Ciprofloxacin Therapy in Avoidance of Sepsis in Patient Undergoing Percutanous Nephrolithotomy

Not Applicable

• Conditions: Nephrolithiasis
• Interventions: Drug: Ciprofloxacin; Drug: Levofloxacin

• Registration Number: NCT04374188
• Lead Sponsor: Diaa Eldin Taha Ramadan Mohamed

Brief Summary

Efficacy of ciprofloxacin therapy in avoidance of sepsis in patient undergoing percutanous nephrolithotomy. A randomized controlled trial.

Detailed Description

To figure out the value of oral ciprofloxacin medication in ameliorate the outcome of renal nephrolithiasis extraction via the endoscope as regard the sepsis.

Study Timeline

• Study Start: 2019-09-01
• Study First Submitted: 2020-04-18
• Study First Submitted QC: 2020-05-01
• Study First Posted: 2020-05-05
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03
• Primary Completion: 2021-09-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1. Patient 18 years or older
• Stones ≥ 2 cm and/or mild to moderate hydronephrosis
• Sterile mid urine stream

Exclusion Criteria

• Patients with a stent, nephrostomy tube or indwelling catheter
• Renal failure
• Fever before surgery
• Previous manipulation/procedure
• Concomitant bladder stone or tumour
• Patients with active UTI
• Contralateral renal/ureteric stone

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ciprofloxacin	Ciprofloxacin	ciprofloxacin tablets
levofloxacin	Levofloxacin	levofloxacin tablets

Primary Outcome Measures

Name	Time	Method
Effect of ciprofloxacin versus levofloxacin duration before PCNL	12 months	To evaluate whether 7 days of ciprofloxacin or levofloxacin before PCNL, can reduce upper urinary tract infection and urosepsis after PCNL.

Secondary Outcome Measures

Name	Time	Method
predictors of systemic inflammatory response syndeome (SIRS) and sepsis post PCNL.	12 months	assess the risk factors for SIRS and sepsis in PCNL.
differences between Culture and sensitivity (C&S) of Preoperative urine (MSU) and intraoperative renal pelvic urine	12 months	Compare the difference between C\&S of Preoperative urine (MSU) and intraoperative renal pelvic urine and extracted stone, in predicting the upper urinary tract infection and urosepsis.

Trial Locations

Locations (1)

Kafrelsheikh faculty of medicine; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt