Actively Recruiting
Gram Stain of the First Urine After Intraoperative Renal Puncture to Predict Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Randomized Controlled Study
Led by Adiyaman University · Updated on 2025-01-22
245
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of Gram staining of the first urine collected after kidney puncture during percutaneous nephrolithotomy (PCNL) to predict systemic inflammatory responses in patients undergoing this procedure. The study compares patients receiving an expanded empirical antibiotic regimen based on the Gram stain results to those whose antibiotic treatment is adjusted later according to symptoms and culture outcomes. The goal is to evaluate the diagnostic value of Gram stain in anticipating and preventing post-surgical complications. Participants are randomly assigned to one of two groups: the experimental group receives antibiotic treatment guided by Gram staining of the first urine after the renal puncture, while the control group undergoes PCNL without this intervention, relying on standard care and symptom-based antibiotic adjustments. This is a prospective, randomized controlled study with triple masking to reduce bias. During the study, researchers will assess the effectiveness of Gram stain in predicting systemic inflammatory responses immediately after surgery and monitor changes in antibiotic regimens based on bacterial findings. Patients will be observed for signs of inflammation and infection, with data collected promptly post-operation to evaluate the impact of the diagnostic approach on clinical outcomes and antibiotic use.
CONDITIONS
Brief Title
Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with an indication for percutaneous nephrolithotomy due to kidney stone disease
- Age 18 years or older
You will not qualify if you...
- Under 18 years old
- Active urinary tract infection before surgery or positive urine cultures
- Bilateral kidney stones
- DJ stent or nephrostomy placement
- Solitary kidney stones
- Bleeding disorders
- Impaired kidney function
- Antibiotic use within 2 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Day of surgery
Participants undergo percutaneous nephrolithotomy during which the first urine after intraoperative renal puncture is collected for Gram staining to predict systemic inflammatory response.
1 surgery visit (in-person)
Trial Site Locations
Total: 1 location
1
Adıyaman University, Medicine of Faculty
Adıyaman, Turkey (Türkiye), 02400
Actively Recruiting
Research Team
B
Bedreddin Kalyenci
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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