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

NCT ID: NCT06210425

Last Updated: 2025-11-21

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

COMPLETED

Total Enrollment

147 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-11-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Kidney Calculi Urinary Tract Infections Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Preoperative urine culture positive group

Preoperative urine culture was positive

No interventions assigned to this group

Preoperative urine culture negative group

preoperative urine culture was negative

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Junhao Zheng

OTHER

Sponsor Role lead

Responsible Party

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Junhao Zheng

Resident

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, GuangGong, China

Site Status

Countries

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China

Other Identifiers

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12440100455344205E

Identifier Type: -

Identifier Source: org_study_id

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