Retrograde intrarenal surgery (RIRS) is a widely used treatment for kidney stones; however, postoperative infectious complications remain a significant concern. This prospective randomized factorial trial aims to evaluate whether gentamicin-containing irrigation fluid and the use of a suction ureteral access sheath can reduce postoperative fever, systemic inflammatory response syndrome (SIRS), and sepsis after RIRS. The study will also investigate the independent and combined effects of these two interventions on infectious outcomes.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether using an antibiotic-flushing ureteral access sheath during the kidney stone procedure reduces serious complications like fever, SIRS, and sepsis — how likely am I to develop those complications with a standard procedure, and would that risk make me a good candidate to discuss this study with you?
2Since this trial isn't recruiting yet, what is my best option right now for treating my kidney stone — is waiting for this trial realistic, or should we move forward with standard retrograde intrarenal surgery?
3The trial is listed as 'Phase NA,' which often means it's a device or technique study rather than a drug trial — can you explain what that means for how much safety and effectiveness data already exists for this antibiotic irrigation approach?
4If I were eventually to participate in this kind of trial, would there be a version of the procedure where I might not receive the antibiotic irrigation — and how would that affect my risk of infection compared to whatever you'd normally do for me?
5Are there already standard measures you use during my type of kidney stone surgery to prevent urinary tract infections and sepsis, and how would participating in a study like this compare to or change those existing protections?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.