Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06393062

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with an indication for percutaneous nephrolithotomy due to kidney stone disease
  • Age 18 years or older
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

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

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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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