Evaluating the need for urine culture re-examination before kidney stone surgery
Is Re-examination of Urine Culture Necessary for Patients With Preoperative Positive Results in Predicting Infectious Complications Related to Mini-Percutaneous Nephrolithotomy?
This study is testing if checking urine cultures again is needed for patients with kidney stones before they have surgery to see if it helps prevent infections afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University Academic / other |
| Locations | 1 site (Guangzhou, GuangGong) |
| Trial ID | NCT06210425 on ClinicalTrials.gov |
What this trial studies
This study investigates whether re-examining urine cultures is necessary for patients with positive preoperative results before undergoing mini-percutaneous nephrolithotomy (PCNL) for kidney stones. It collects clinical data from patients treated with sensitive antibiotics based on their urine culture results. The study analyzes the correlation between urine culture results on days 3 and 7 post-treatment and the occurrence of infectious complications after surgery. The goal is to clarify the best practices for antibiotic use and urine culture management in this patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with kidney stones larger than 2 cm and a positive midstream urine culture who consent to undergo PCNL.
Not a fit: Patients with renal tumors, severe renal dysfunction, or those who have recently used antibiotics may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes by reducing the risk of infectious complications in patients undergoing kidney stone surgery.
How similar studies have performed: While there is ongoing debate in the literature regarding urine culture management in similar contexts, this specific approach has not been extensively tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, GuangGong
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, GuangGong, China (Recruiting)
Study contacts
- Study coordinator: Yongda Liu, Ph.D
- Email: 13719007083@163.com
- Phone: 18922347906
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.