Is it Necessary for Patients With a Positive Urine Culture to Achieve a Negative Result After Antimicrobial Treatment Before Undergoing Percutaneous Nephrolithotomy?

November 18, 2025 updated by: Junhao Zheng

Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?

Objective: The current European Association of Urology (EAU) guidelines do not provide clear recommendations on whether patients with a positive urine culture(UC) should wait until the culture turns negative following antimicrobial treatment before undergoing percutaneous nephrolithotomy (PCNL). This study evaluates the necessity of achieving a negative UC after treatment with sensitive antibiotics before performing PCNL.

Methods: A prospective, continuous study was carried out involving patients with a positive UC who underwent percutaneous nephrolithotomy (PCNL) at the Department of Urology, The First Affiliated Hospital of Guangzhou Medical University, between March 2021 and April 2024. Patients received treatment with sensitive antibiotics for 5 to 7 days based on the drug susceptibility results of their initial UC upon admission. Follow-up UCs were performed on the third day after starting antibiotic treatment and again immediately before the surgery. An analysis was conducted to examine the relationship between UC results at the two specified time points and the occurrence of infectious complications following PCNL.

Study Overview

Status

Completed

Conditions

Detailed Description

For large renal stones, percutaneous nephrolithotomy (PCNL) is the recommended standard surgical approach, especially in cases involving infectious renal stones. Postoperative infections have become the most common complication associated with PCNL, often necessitating additional antimicrobial treatment and prolonged hospitalization. Therefore, it is critically important to identify the risk factors linked to infections after PCNL. Preoperative UC directs antibiotic treatment and mitigates infectious complications post-PCNL. Even with negative preoperative UCs and suitable antibiotic treatment, SIRS or sepsis may still develop post-PCNL. Several studies have indicated that a preoperative UC obtained before antibiotic administration is not a reliable predictor of postoperative infectious complications. Nonetheless, there has been limited research on the relationship between repeat UCs after antibiotic treatment and post-PCNL infectious complications. This research assesses the necessity of achieving a negative UC after treatment with sensitive antibiotics before undergoing PCNL.

Study Type

Observational

Enrollment (Actual)

147

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • GuangGong
      • Guangzhou, GuangGong, China, 510500
        • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients received treatment with sensitive antibiotics for 5 to 7 days based on the drug susceptibility results of their initial UC upon admission. Follow-up UCs were performed on the third day after starting antibiotic treatment and again immediately before the surgery. An analysis was conducted to examine the relationship between UC results at the two specified time points and the occurrence of infectious complications following PCNL.

Description

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Renal stone diameter ≥ 2 cm, complex renal stones, or failed ESWL treatment.
  3. Consent to undergo PCNL with a positive midstream urine culture preoperatively.
  4. ASA score of I or II.

Exclusion Criteria:

  1. Coexisting renal tumor.
  2. Use of antibiotics within the past two weeks.
  3. Renal dysfunction (serum creatinine >451 μmol/L).
  4. Unresolved hemorrhage or coagulation abnormalities.
  5. Patients who have undergone percutaneous renal fistula or have a ureteral stent in place on the affected side.
  6. Simultaneous bilateral renal stone surgery.
  7. Severe underlying diseases, such as respiratory or circulatory insufficiency, that cannot tolerate anesthesia or surgery.
  8. Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Preoperative urine culture positive group
Preoperative urine culture was positive
Preoperative urine culture negative group
preoperative urine culture was negative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urosepsis
Time Frame: Within 7 days postoperatively
①Confirmed urinary tract infection; ②SOFA (Sequential Organ Failure Assessment) score ≥2 points. A diagnosis of urosepsis can be made if both of the above conditions are met.
Within 7 days postoperatively
SIRS
Time Frame: Within 7 days postoperatively
The presence of at least two of the following four criteria defines SIRS following PCNL: heart rate greater than 90/min, white blood cell count ≥12 × 10^9/L or ≤4 × 10^9/L, body temperature above 38°C or under 36°C, and respiratory rate greater than 20/min.
Within 7 days postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fever
Time Frame: Within 7 days postoperatively
Postoperative body temperature >38°C
Within 7 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Junhao Zheng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

November 10, 2024

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 17, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 18, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12440100455344205E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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