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Recruiting NCT06393062

Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

No phase Interventional Percutaneous Nephrolithotomy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy..
Who it may be relevant to
Registry conditions: Percutaneous Nephrolithotomy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study

Overview

In this study, investigators compared the systemic inflammatory responses after percutaneous nephrolithotomy (PCNL) patients who were given an expanded empirical antibiotic regimen based on the prediction of the possibility of bacteria identified by Gram staining the first urine after renal puncture and patients whose antibiotic regimen was not performed and whose antibiotic regimen was adjusted according to patient symptoms and culture results. Investigators aimed to test its diagnostic value in predicting and preventing complications.

Interventions

  • Diagnostic test Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.
    Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.

Primary outcome measures

  • Efficacy of Gram stain in predicting systemic inflammatory response after percutaneous nephrolithotomy. [Time frame: immediately after the surgery]
Secondary outcome measures (1)
  • Change of antibiotic regimen after bacterial estimation of Gram stain [Time frame: immediately after the surgery]

Eligibility criteria

Inclusion criteria

  • patients with an indication for percutaneous nephrolithotomy due to kidney stone disease.

Exclusion criteria

  • 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,
  • a history of antibiotic use for any reason within 2 weeks before randomization were excluded from the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Turkey (Türkiye) · 1 center
  • Adıyaman University, Medicine of Faculty — Adıyaman

Identifiers

NCT: NCT06393062 · 2022/7-17

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗