A Novel Method for Retrograde Intrarenal Surgery (RIRS)
A Novel Method for Stone Area Sterilization During Retrograde Intrarenal Surgery (RIRS)
1 other identifier
interventional
76
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJuly 7, 2022
July 1, 2022
6 months
January 10, 2022
July 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of postoperative complications
Rate of patients who had an complication after the operation
One year
Study Arms (2)
Irrigation + Genta
ACTIVE COMPARATORPatients treated with gentamicin in irrigation fluid during RIRS
Irrigation
SHAM COMPARATORPatients treated only irrigation fluid during RIRS
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- \<2 cm. kidney stones
You may not qualify if:
- Ureteral stricture
- Active urinary tract infection
- Coagulopathies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Training and Research Hospital
Ankara, Altindag, 06230, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 26318710RESULTWalton-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.
PMID: 27848063RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Kaan Yildiz
Ankara Training and Resarch Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 10, 2022
First Posted
January 21, 2022
Study Start
February 15, 2022
Primary Completion
August 1, 2022
Study Completion
September 1, 2022
Last Updated
July 7, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share