A Novel Method for Retrograde Intrarenal Surgery (RIRS)

NCT ID: NCT05202158

Last Updated: 2022-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2022-09-01

Brief Summary

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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

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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.

Conditions

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Kidney Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Irrigation + Genta

Patients treated with gentamicin in irrigation fluid during RIRS

Group Type ACTIVE_COMPARATOR

Addition of gentamicin to irrigation fluid during RIRS

Intervention Type PROCEDURE

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.

Irrigation

Patients treated only irrigation fluid during RIRS

Group Type SHAM_COMPARATOR

Only irrigation fluid during RIRS

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \<2 cm. kidney stones

Exclusion Criteria

* Ureteral stricture
* Active urinary tract infection
* Coagulopathies
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ali Kaan Yildiz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Kaan Yildiz

Role: PRINCIPAL_INVESTIGATOR

Ankara Training and Resarch Hospital

Locations

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Ankara Training and Research Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Ali Kaan Yildiz

Role: CONTACT

+90 554 773 16 96

Esra Gulen Yildiz

Role: CONTACT

+90 506 877 47 09

Facility Contacts

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Ali Kaan Yildiz

Role: primary

+90 554 773 16 96

References

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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.

Reference Type RESULT
PMID: 26318710 (View on PubMed)

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.

Reference Type RESULT
PMID: 27848063 (View on PubMed)

Other Identifiers

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RIRS2022

Identifier Type: -

Identifier Source: org_study_id

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