A Novel Method for Retrograde Intrarenal Surgery (RIRS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Stone
• Intervention / Treatment: Procedure: Addition of gentamicin to irrigation fluid during RIRS; Procedure: Only irrigation fluid during RIRS

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altindag
    • Ankara, Altindag, Turkey, 06230
      • Recruiting
      • Ankara Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• <2 cm. kidney stones

Exclusion Criteria:

• Ureteral stricture
• Active urinary tract infection
• Coagulopathies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Irrigation + Genta; Patients treated with gentamicin in irrigation fluid during RIRS	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.
SHAM_COMPARATOR: Irrigation; Patients treated only irrigation fluid during RIRS	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ankara Training and Research Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2022
• Primary Completion (ANTICIPATED): August 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (ACTUAL): January 21, 2022

Study Record Updates

• Last Update Posted (ACTUAL): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 4, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Nephrolithiasis; Kidney Calculi; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: RIRS2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No