Back to resultsComparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
Primary Purpose
Nephrolithiasis
Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Retrograde Intrarenal Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Nephrolithiasis focused on measuring RIRS, holmium, 1-2 cm,stones,kidney
Eligibility Criteria
Inclusion Criteria:
- Patients who are between 18-90 years old
- Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones
Exclusion Criteria:
- Patients who have congenital urogenital abnormalities
- Patients who have previous stone surgery history
Sites / Locations
- Tuekey Ministry of HealthDıskapı Yıldırım Beyazıt Training and Research HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
first group
second group
third group
Arm Description
Patients undergoing Retrograde Intrarenal Surgery with 20w holmium laser device who have 1-2 cm diameter kidney stones
Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser device (working over 20w power) who have 1-2 cm diameter kidney stones
Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser(working under 20w power) device who have 1-2 cm diameter kidney stones
Outcomes
Primary Outcome Measures
Safety - complications according to clavien system
complications according to clavien system
safety - visual analog score
visual analog score
Secondary Outcome Measures
efficiency - stone free rate
stone free rate post operative first day
Full Information
NCT ID
NCT02451319
First Posted
April 28, 2015
Last Updated
May 20, 2015
Sponsor
Diskapi Teaching and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02451319
Brief Title
Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
Official Title
Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the safety and Efficiency of 20w 30w holmium laser device in treatment of 1-2 cm diameter kidney stones with Retrograde Intrarenal Surgery (RIRS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrolithiasis
Keywords
RIRS, holmium, 1-2 cm,stones,kidney
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
first group
Arm Type
Active Comparator
Arm Description
Patients undergoing Retrograde Intrarenal Surgery with 20w holmium laser device who have 1-2 cm diameter kidney stones
Arm Title
second group
Arm Type
Active Comparator
Arm Description
Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser device (working over 20w power) who have 1-2 cm diameter kidney stones
Arm Title
third group
Arm Type
Active Comparator
Arm Description
Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser(working under 20w power) device who have 1-2 cm diameter kidney stones
Intervention Type
Procedure
Intervention Name(s)
Retrograde Intrarenal Surgery
Intervention Description
Endoscopic treatment of Kidney Stones
Primary Outcome Measure Information:
Title
Safety - complications according to clavien system
Description
complications according to clavien system
Time Frame
postoperative 24 hours
Title
safety - visual analog score
Description
visual analog score
Time Frame
postoperative 24 hours
Secondary Outcome Measure Information:
Title
efficiency - stone free rate
Description
stone free rate post operative first day
Time Frame
postoperative 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who are between 18-90 years old
Patients undergoing RIRS for treatment of 1-2 cm diameter kidney stones
Exclusion Criteria:
Patients who have congenital urogenital abnormalities
Patients who have previous stone surgery history
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nihat Karakoyunlu, MD
Phone
00905324747134
Email
nkarakoyunlu@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
Organizational Affiliation
Dıskapı TRH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuekey Ministry of HealthDıskapı Yıldırım Beyazıt Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
Phone
00905324747134
Email
nkarakoyunlu@gmail.com
First Name & Middle Initial & Last Name & Degree
Nihat Karakoyunlu, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
25443519
Citation
Redondo C, Ramon de Fata F, Gimbernat H, Meilan E, Andres G, Angulo JC. Retrograde intrarenal surgery with holmium-YAG laser lithotripsy in the primary treatment of renal lithiasis. Actas Urol Esp. 2015 Jun;39(5):320-6. doi: 10.1016/j.acuro.2014.06.004. Epub 2014 Oct 25. English, Spanish.
Results Reference
result
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Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS
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