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A Novel Method for Retrograde Intrarenal Surgery (RIRS)

Primary Purpose

Kidney Stone

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Addition of gentamicin to irrigation fluid during RIRS
Only irrigation fluid during RIRS
Sponsored by
Ankara Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • <2 cm. kidney stones

Exclusion Criteria:

  • Ureteral stricture
  • Active urinary tract infection
  • Coagulopathies

Sites / Locations

  • Ankara Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Irrigation + Genta

Irrigation

Arm Description

Patients treated with gentamicin in irrigation fluid during RIRS

Patients treated only irrigation fluid during RIRS

Outcomes

Primary Outcome Measures

Rate of postoperative complications
Rate of patients who had an complication after the operation

Secondary Outcome Measures

Full Information

First Posted
January 10, 2022
Last Updated
July 4, 2022
Sponsor
Ankara Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05202158
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irrigation + Genta
Arm Type
Active Comparator
Arm Description
Patients treated with gentamicin in irrigation fluid during RIRS
Arm Title
Irrigation
Arm Type
Sham Comparator
Arm Description
Patients treated only irrigation fluid during RIRS
Intervention Type
Procedure
Intervention Name(s)
Addition of gentamicin to irrigation fluid during RIRS
Intervention Description
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
Intervention Name(s)
Only irrigation fluid during RIRS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of postoperative complications
Description
Rate of patients who had an complication after the operation
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: <2 cm. kidney stones Exclusion Criteria: Ureteral stricture Active urinary tract infection Coagulopathies
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Kaan Yildiz
Phone
+90 554 773 16 96
Email
alikaanyildiz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Gulen Yildiz
Phone
+90 506 877 47 09
Email
esragln90@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Kaan Yildiz
Organizational Affiliation
Ankara Training and Resarch Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Kaan Yildiz
Phone
+90 554 773 16 96
Email
alikaanyildiz@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26318710
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.
Results Reference
result
PubMed Identifier
27848063
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.
Results Reference
result

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A Novel Method for Retrograde Intrarenal Surgery (RIRS)

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