A Novel Method for Retrograde Intrarenal Surgery (RIRS)

Study Overview
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Brief Summary
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In this prospective randomised controlled study, investigators aims to evaluate the effect of 80 mg gentamicin added to 3 liters of irrigation fluid on stone free rate, intraoperative and postoperative complications during RIRS for kidney stones.

Detailed Description
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Current advances in endoscopic technology for the upper urinary tract have expanded the diagnosis and treatment options for kidney stones. Retrograde intrarenal surgery (RIRS), defined as the use of effective lithotripters such as flexible ureteroscopes (fURSs) and holmium:yttrium aluminum garnet (holmium:YAG) lasers for intrarenal pelvic diseases, is a safe and effective, versatile and minimally invasive procedure for the kidney. . Current guidelines for the treatment of kidney stones recommend RIRS first for stones <2 cm. and RIRS as one of the first two options for stones >2 cm.. In studies dealing with kidney stones larger than 2 cm, the RIRS showed a cumulative stone-free success of 91%, but a complication rate of 8.6%. Of these, 44% were found to be ≥ Clavien 3 complications. In kidney stone endourological treatments, stone culture was found to be more effective in predicting complications than midstream urine culture. Even if the preoperative midstream urine culture is sterile, complication rates increase if there is bacterial growth in the stone culture in kidney stone surgery. Therefore, although complication rates are generally low, several concerns have arisen. In our study, the investigators aims to evaluate the effect of 80 mg gentamicin added to 3 liters of irrigation fluid on stone free rate and complications during RIRS for kidney stones.

Official Title
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A Novel Method for Stone Area Sterilization During Retrograde Intrarenal Surgery (RIRS)

Conditions
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Kidney Stone

Intervention / Treatment
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* Procedure: Addition of gentamicin to irrigation fluid during RIRS
* Procedure: Only irrigation fluid during RIRS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <2 cm. kidney stones Exclusion Criteria: Ureteral stricture Active urinary tract infection Coagulopathies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Irrigation + Genta<br>Patients treated with gentamicin in irrigation fluid during RIRS | Procedure: Addition of gentamicin to irrigation fluid during RIRS<br>* During the RIRS, the access sheath is placed first for security. Then, the stone in the kidney is detected with flexible URS and fragmented with a holmium laser. In this group of patients, 80 mg of gentamicin will be added to 3 liters of irrigation fluid while the stone is being fragmented.<br>|
| Sham Comparator: Irrigation<br>Patients treated only irrigation fluid during RIRS | Procedure: Only irrigation fluid during RIRS<br>* During the RIRS, the access sheath is placed first for security. Then, the stone in the kidney is detected with flexible URS and fragmented with a holmium laser. In this group of patients, only irrigation fluid will be used while the stone is fragmented.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative complications | Rate of patients who had an complication after the operation | One year |