Actively Recruiting
Gram Stain of the First Urine After Kidney Puncture to Predict Inflammation During Percutaneous Nephrolithotomy A Prospective, Randomized Study
Led by Adiyaman University · Updated on 2025-01-22
245
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well Gram staining of the first urine sample taken during kidney puncture can predict systemic inflammatory responses after percutaneous nephrolithotomy (PCNL), a procedure to remove kidney stones. The study compares patients who receive an expanded antibiotic treatment based on this Gram stain prediction to those whose antibiotic treatment is adjusted later according to symptoms and culture results. The goal is to test whether this diagnostic approach can help predict and prevent complications after PCNL. The main intervention involves performing Gram staining on the first urine collected during the renal puncture in surgery to guide antibiotic treatment. Patients are divided into groups: one where antibiotics are given based on the Gram stain result immediately after surgery, and another where antibiotics are given based on later clinical symptoms and culture findings. This approach aims to personalize antibiotic use to reduce inflammatory complications after the procedure. Participants will be monitored immediately after surgery to assess the effectiveness of Gram staining in predicting systemic inflammatory response. Researchers will track inflammation signs and compare outcomes between the two groups. Data from urine tests and patient clinical status will be collected to measure the diagnostic value of the Gram stain method. The total duration of participation corresponds to the immediate postoperative period when complications typically arise.
CONDITIONS
Official 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.
You will not qualify if you...
- Under 18 years old
- Having an active urinary tract infection before surgery and positive urine cultures
- Patients with bilateral kidney stones
- DJ stent or nephrostomy placement
- Solitary kidney stones
- Bleeding disorders
- Impaired kidney function
- History of antibiotic use within 2 weeks before randomization
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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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