A Novel Method for Retrograde Intrarenal Surgery (RIRS)

Not Applicable

• Conditions: Kidney Stone
• Interventions: Procedure: Only irrigation fluid during RIRS; Procedure: Addition of gentamicin to irrigation fluid during RIRS

• Registration Number: NCT05202158
• Lead Sponsor: Ankara Training and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-01-10
• Study First Submitted QC: 2022-01-10
• Study First Posted: 2022-01-21
• Study Start: 2022-02-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-07
• Primary Completion: 2022-08-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• <2 cm. kidney stones

Exclusion Criteria

• Ureteral stricture
• Active urinary tract infection
• Coagulopathies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irrigation	Only irrigation fluid during RIRS	Patients treated only irrigation fluid during RIRS
Irrigation + Genta	Addition of gentamicin to irrigation fluid during RIRS	Patients treated with gentamicin in irrigation fluid during RIRS

Primary Outcome Measures

Name	Time	Method
Rate of postoperative complications	One year	Rate of patients who had an complication after the operation

Trial Locations

Locations (1)

Ankara Training and Research Hospital; 🇹🇷 Ankara, Altindag, Turkey