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Completed

NCT Number: NCT06210425

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Junhao Zheng

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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