Using Gram Stain of Urine to Improve Outcomes After Kidney Stone Surgery
Gram Stain of the First Urine After Intraoperative Renal Puncture in Predicting the Systemic Inflammatory Response After Percutaneous Nephrolithotomy: A Prospective, Randomized Controlled Study
NA · Adiyaman University · NCT06393062
This study tests if using a special urine test after kidney stone surgery can help doctors choose better antibiotics to prevent complications and improve recovery for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 245 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Adiyaman University (other) |
| Locations | 1 site (Adıyaman) |
| Trial ID | NCT06393062 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of using Gram staining of the first urine collected after renal puncture during percutaneous nephrolithotomy (PCNL) to predict systemic inflammatory responses. Patients will receive either an expanded empirical antibiotic regimen based on Gram stain results or a standard regimen adjusted according to symptoms and culture results. The goal is to assess whether this approach can help prevent complications and improve patient outcomes following surgery.
Who should consider this trial
Good fit: Ideal candidates are adults with indications for percutaneous nephrolithotomy due to kidney stone disease.
Not a fit: Patients under 18 years old or those with active urinary tract infections or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of infections and reduced complications for patients undergoing kidney stone surgery.
How similar studies have performed: While similar approaches have been explored, this specific method of using Gram staining in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Adıyaman
- Adıyaman University, Medicine of Faculty — Adıyaman, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Bedreddin Kalyenci
- Email: bedreddin84@windowslive.com
- Phone: +905554859583
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.
Conditions: Percutaneous Nephrolithotomy, fever, gram stain, percutaneous nephrolithotomy, Systemic inflammatory response syndrome