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Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

A

Adiyaman University

Status

Enrolling

Conditions

Percutaneous Nephrolithotomy

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06393062
2022/7-17

Details and patient eligibility

About

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.

Enrollment

245 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

245 participants in 2 patient groups

Gram staining
Experimental group
Description:
Gram staining of post-puncture urine in percutaneous nephrolithotomy
Treatment:
Diagnostic Test: Gram staining of the first urine after intraoperative renal puncture to predict the systemic inflammatory response after percutaneous nephrolithotomy.
control
No Intervention group
Description:
non-intervention percutaneous nephrolithotomy

Trial contacts and locations

1

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Central trial contact

Bedreddin Kalyenci

Data sourced from clinicaltrials.gov

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