An interventional study of Standard Retrograde Intrarenal Surgery and Gentamicin Irrigation in Kidney Calculi, Urolithiasis and Urinary Tract Infections, sponsored by Hitit University. Recruiting at 2 sites in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Hitit University · Not applicable, Interventional, and Prevention
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.
Subject:
The present study aims to investigate the effects of gentamicin-containing irrigation and the use of a suction ureteral access sheath during retrograde intrarenal surgery (RIRS) on postoperative infectious complications.
Objective:
The aim of this study is to evaluate the independent and combined effects of gentamicin irrigation and a suction ureteral access sheath on postoperative infectious complications following RIRS.
Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive treatment modality for renal stones, particularly for stones up to 20 mm. Although RIRS is generally considered safe and effective, postoperative infectious complications remain an important clinical concern. Fever, urinary tract infection, systemic inflammatory response syndrome (SIRS), and sepsis may occur even in patients with negative preoperative urine cultures and appropriate perioperative antibiotic prophylaxis.
A potential mechanism for infectious complications after RIRS is increased intrarenal pressure during endoscopic lithotripsy. Elevated intrarenal pressure may promote pyelovenous and pyelolymphatic backflow, allowing bacteria, endotoxins, and inflammatory mediators from the collecting system or stone surface to enter the systemic circulation. Therefore, strategies that reduce bacterial contamination within the renal collecting system and improve intrarenal drainage may help decrease postoperative infectious morbidity.
This study is designed to evaluate two intraoperative strategies intended to reduce infectious complications during RIRS. The first strategy is local antibiotic irrigation using gentamicin-containing saline solution. Gentamicin will be added to the irrigation fluid as a local intraoperative measure rather than as a systemic treatment. This approach is intended to reduce bacterial contamination within the collecting system during lithotripsy. All patients will also receive standard systemic antibiotic prophylaxis according to routine clinical practice.
The second strategy is the use of a suction-enabled ureteral access sheath. This device is intended to improve fluid evacuation, reduce intrarenal pressure, and facilitate the removal of stone dust, debris, and potentially contaminated fluid during the procedure. By improving drainage from the collecting system, suction-assisted RIRS may theoretically reduce pyelovenous backflow and the risk of postoperative systemic inflammatory or infectious events.
The study uses a 2×2 factorial design, which allows simultaneous evaluation of the independent effects of gentamicin irrigation and suction-enabled ureteral access sheath use, as well as their combined effect. This design is useful because both interventions target different mechanisms that may contribute to infectious complications: local bacterial contamination and elevated intrarenal pressure. The factorial structure will also allow assessment of whether the combination of these two approaches provides an additive or synergistic benefit compared with either intervention alone.
All procedures will be performed under general anesthesia in the lithotomy position using standard endourological techniques. Irrigation will be performed with normal saline under low-pressure conditions. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline. In the suction groups, a suction-enabled ureteral access sheath will be used during flexible ureteroscopy. Stone fragmentation will be performed with a holmium:YAG laser using a dusting technique, and a double-J ureteral stent will be placed at the end of the procedure according to the study protocol.
This trial may provide clinically relevant evidence regarding infection-prevention strategies in RIRS. If gentamicin irrigation, suction-assisted access sheath use, or their combination is shown to reduce postoperative infectious complications without compromising surgical success, these approaches may contribute to safer perioperative management in endourological stone surgery.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 180 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Hitit University is the lead sponsor of 87 studies on the registry; 29 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will undergo standard retrograde intrarenal surgery using standard saline irrigation and a standard ureteral access sheath. This arm will serve as the control group for comparison with gentamicin irrigation, suction-enabled ureteral access sheath use, and the combined intervention.
Procedure: Standard Retrograde Intrarenal Surgery
Arm Description: Participants in this arm will undergo standard retrograde intrarenal surgery using gentamicin-containing irrigation fluid. Gentamicin will be added to normal saline irrigation solution during the procedure. A standard ureteral access sheath will be used without suction assistance.
Procedure: Standard Retrograde Intrarenal Surgery · Drug: Gentamicin Irrigation
Participants in this arm will undergo retrograde intrarenal surgery using a suction-enabled ureteral access sheath. The suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure. Standard saline irrigation will be used without gentamicin.
Device: Suction-Enabled Ureteral Access Sheath
Participants in this arm will undergo retrograde intrarenal surgery using both gentamicin-containing irrigation fluid and a suction-enabled ureteral access sheath. Gentamicin will be added to normal saline irrigation solution, and the suction-enabled sheath will be used to improve fluid evacuation and reduce intrarenal pressure during the procedure.
Drug: Gentamicin Irrigation · Device: Suction-Enabled Ureteral Access Sheath
Standard retrograde intrarenal surgery will be performed under general anesthesia in the lithotomy position. A guidewire will be advanced to the renal pelvis under fluoroscopic guidance, and a ureteral access sheath will be placed when appropriate. Flexible ureteroscopy will be performed, and stones will be fragmented using a holmium laser with the dusting technique. Standard saline irrigation will be used during the procedure.
Also known as: Standard RIRS Flexible Ureteroscopy
Gentamicin-containing irrigation fluid will be used during retrograde intrarenal surgery. In the gentamicin irrigation groups, 80 mg gentamicin will be added to each 3 L bag of normal saline irrigation solution. This intervention will be used as a local intraoperative irrigation strategy to reduce bacterial contamination within the renal collecting system and is not intended as systemic antibiotic treatment.
Also known as: Gentamicin-Containing Irrigation Local Antibiotic Irrigation Intervention Description:
A suction-enabled ureteral access sheath will be used during retrograde intrarenal surgery in the suction groups. The device is intended to improve fluid evacuation from the renal collecting system, reduce intrarenal pressure, and facilitate removal of irrigation fluid, stone dust, and debris during flexible ureteroscopy.
Also known as: Suction UAS Aspiration Ureteral Access Sheath Suction-Assisted Ureteral Access Sheath
Postoperative Fever
Postoperative fever will be defined as a body temperature greater than 38°C occurring within the first 48 hours after retrograde intrarenal surgery.
Time frame: Within 48 hours after surgery
Systemic Inflammatory Response Syndrome
Systemic inflammatory response syndrome will be defined as the presence of at least two of the following criteria: body temperature greater than 38°C or less than 36°C, heart rate greater than 90 beats/min, respiratory rate greater than 20 breaths/min, or white blood cell count greater than 12,000/mm³ or less than 4,000/mm³.
Time frame: Within 48 hours after surgery
Sepsis
Sepsis will be defined as systemic inflammatory response syndrome in the presence of confirmed or suspected infection after retrograde intrarenal surgery.
Time frame: Within 48 hours after surgery
Stone-Free Rate
Stone-free status will be evaluated using non-contrast computed tomography. Residual fragments of 4 mm or less will be considered clinically insignificant.
Time frame: 4 weeks after surgery
Change in White Blood Cell Count
White blood cell count will be assessed before and after surgery to evaluate postoperative inflammatory response.
Time frame: Baseline and within 48 hours after surgery
Change in Serum Creatinine
Serum creatinine levels will be assessed before and after surgery to evaluate renal function changes.
Time frame: Baseline and within 48 hours after surgery
Urine Culture Positivity
Postoperative urine culture results will be evaluated to identify urinary tract infection and causative microorganisms.
Time frame: Within 48 hours after surgery
Blood Culture Positivity
Postoperative blood culture results will be evaluated in patients with suspected systemic infection to identify bloodstream infection and causative microorganisms.
Time frame: Within 48 hours after surgery
Plan to share: No
Started Jun 2026 (actual). Primary completion is estimated for Feb 2027, 7 months after the start.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 7 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
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