A Novel Method for Retrograde Intrarenal Surgery (RIRS)

Kidney Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05202158
• Other study ID #: RIRS2022
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2022
• Source: Ankara Training and Research Hospital
• Contact: Ali Kaan Yildiz
• Phone: +90 554 773 16 96
• Email: alikaanyildiz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: September 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• <2 cm. kidney stones

Exclusion Criteria:

• Ureteral stricture

• Active urinary tract infection

• Coagulopathies

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone

Intervention

Procedure:
• Addition of gentamicin to irrigation fluid during RIRS
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.
• Only irrigation fluid during RIRS
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.

Locations

Country	Name	City	State
Turkey	Ankara Training and Research Hospital	Ankara	Altindag

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Türk C, Petrík 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. Review. — View Citation

Walton-Diaz A, Vinay JI, Barahona J, Daels P, González M, Hidalgo JP, Palma C, Díaz 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. In — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of postoperative complications	Rate of patients who had an complication after the operation	One year