Clinical trial NCT05202158: A Novel Method for Retrograde Intrarenal Surgery (RIRS)
Official title: A Novel Method for Stone Area Sterilization During Retrograde Intrarenal Surgery (RIRS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Stone
Lead sponsor: Ankara Training and Research Hospital
Sponsor class: OTHER
First posted: 2022-01-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* \<2 cm. kidney stones

Exclusion Criteria:

* Ureteral stricture
* Active urinary tract infection
* Coagulopathies

Primary outcomes:
measure: Rate of postoperative complications
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Training and Research Hospital
state: Altindag
Study officials:
affiliation: Ankara Training and Resarch Hospital
name: Ali Kaan Yildiz
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M, Knoll T. EAU Guidelines on Diagnosis and Conservative Management of Urolithiasis. Eur Urol. 2016 Mar;69(3):468-74. doi: 10.1016/j.eururo.2015.07.040. Epub 2015 Aug 28.
citation: Walton-Diaz A, Vinay JI, Barahona J, Daels P, Gonzalez M, Hidalgo JP, Palma C, Diaz P, Domenech A, Valenzuela R, Marchant F. Concordance of renal stone culture: PMUC, RPUC, RSC and post-PCNL sepsis-a non-randomized prospective observation cohort study. Int Urol Nephrol. 2017 Jan;49(1):31-35. doi: 10.1007/s11255-016-1457-y. Epub 2016 Nov 15.