Gram Stain of the First Urine After Puncture in Percutaneous Nephrolithotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Percutaneous Nephrolithotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients included in the study were randomized by a block randomization method by an independent researcher, hidden from the patients and the responsible clinicians, using a computerized number tool.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Gram staining

Gram staining of post-puncture urine in percutaneous nephrolithotomy

Group Type EXPERIMENTAL

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

Intervention Type DIAGNOSTIC_TEST

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

control

non-intervention percutaneous nephrolithotomy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No