A Novel Method for Retrograde Intrarenal Surgery (RIRS)

Ankara Training and Research Hospital

Status: Enrolling

Conditions: Kidney Stone

Treatments: Procedure: Only irrigation fluid during RIRS; Procedure: Addition of gentamicin to irrigation fluid during RIRS

Study type: Interventional

Funder types: Other

Identifiers

NCT05202158

RIRS2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• <2 cm. kidney stones

Exclusion criteria

• Ureteral stricture
• Active urinary tract infection
• Coagulopathies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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76 participants in 2 patient groups

Irrigation + Genta

Active Comparator group

Description:

Patients treated with gentamicin in irrigation fluid during RIRS

Treatment:

Procedure: Addition of gentamicin to irrigation fluid during RIRS

Irrigation

Sham Comparator group

Description:

Patients treated only irrigation fluid during RIRS

Treatment:

Procedure: Only irrigation fluid during RIRS