Gentamicin Irrigation and Suction Ureteral Access in Kidney Stone Surgery
Official title: The Combined Effect of Antibiotic Irrigation and Aspiration Ureteral Access Sheath on Infectious Complications in Retrograde Intrarenal Surgery: A Prospective Randomized Factorial Study
Run by Hitit University · NCT07655050 · Data updated 2026-11-12
This trial tests whether using gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath during retrograde intrarenal surgery (RIRS) can lower fever, SIRS, and sepsis after kidney stone treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Hitit University Academic / other |
| Locations | 2 sites (Çorum, Çorum and 1 other locations) |
| Status | Recruiting |
| Started | June 15, 2026 |
| Main results expected | February 8, 2027 |
| Study ends | May 8, 2027 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07655050 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with kidney stones scheduled for RIRS, who have sterile urine or have had treated infection with sterile culture.
✕Probably not a fit
Patients with active urinary tract infection at surgery or allergy to gentamicin may not benefit and could be excluded or experience risks.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, factorial trial examines two interventions added to standard RIRS: gentamicin irrigation and a suction-enabled ureteral access sheath. It aims to determine the independent and combined effects of these strategies on postoperative infectious complications after kidney stone surgery. Patients are adults with kidney stones who are scheduled for RIRS and meet safety criteria, with outcomes including fever, SIRS, sepsis, and related infectious events. The study addresses intrarenal pressure and bacterial contamination as potential drivers of postoperative infections. The design compares standard RIRS, gentamicin irrigation, suction sheath, and their combination to identify any reduction in infectious morbidity.
Why it matters
Potential benefit: If successful, this approach could reduce postoperative infections after RIRS and improve patient safety.
How similar studies have gone: There is existing interest in reducing intrarenal pressure and infection risk in RIRS, but this trial explores a novel combination of gentamicin irrigation and suction sheath.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for retrograde intrarenal surgery (RIRS) due to kidney stones * Male and female patients aged 18 years or older * Patients who voluntarily sign the informed consent form * Patients with sterile urine culture or whose preoperative infection has been treated and urine culture has become sterile Exclusion Criteria: * Patients with active urinary tract infection before surgery * Patients with chronic kidney disease * Pregnant patients * Patients with allergy to aminoglycoside-group drugs used in the study protocol, specifically gentamicin * Cases in which the ureter cannot be accessed and the procedure is postponed by placing a double-J stent instead of performing dilation
Where it's running
-
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, Turkey (Türkiye) Recruiting -
Department of Urology, Hitit University Çorum Erol Olçok Training and Research Hospital, Çorum, Türkiye
Çorum, Çorum, Turkey (Türkiye) Not yet recruiting
Study contacts
- Study coordinator: Mustafa Serdar Çağlayan
- Email: serdar.09.09@hotmail.com
- Phone: +90 507 431 1951
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.