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Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery

Primary Purpose

Nephrolithiasis

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery
Holmium laser device
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrolithiasis focused on measuring Holmium Laser, Kidney Stones, RIRS

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients who have 2-3 cm kidney stones
  • patients who are between 18-90 years old

Exclusion Criteria:

  • patients who have congenital urogenital abnormalities
  • patients who have previous surgery history for urinary stones

Sites / Locations

  • S.B.Dıskapı 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 2-3 cm kidney stones

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones

Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston

Outcomes

Primary Outcome Measures

Safety (Complications according to clavien system)
Complications according to clavien system
Efficiency (visual analog score)
visual analog score

Secondary Outcome Measures

Efficiency (stone free rate)
stone free rate/

Full Information

First Posted
April 28, 2015
Last Updated
May 13, 2015
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02443909
Brief Title
Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery
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 safety and efficiency of 20w 30w holmium laser device in treatment of 2-3 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
Holmium Laser, Kidney Stones, RIRS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel 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 2-3 cm 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 2-3 cm kidney stones
Arm Title
third group
Arm Type
Active Comparator
Arm Description
Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston
Intervention Type
Procedure
Intervention Name(s)
Retrograde Intrarenal Surgery
Other Intervention Name(s)
RIRS
Intervention Description
endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
Intervention Type
Procedure
Intervention Name(s)
Retrograde Intrarenal Surgery
Other Intervention Name(s)
RIRS
Intervention Description
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
Intervention Type
Procedure
Intervention Name(s)
Retrograde Intrarenal Surgery
Other Intervention Name(s)
RIRS
Intervention Description
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Intervention Type
Device
Intervention Name(s)
Holmium laser device
Primary Outcome Measure Information:
Title
Safety (Complications according to clavien system)
Description
Complications according to clavien system
Time Frame
1 day
Title
Efficiency (visual analog score)
Description
visual analog score
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Efficiency (stone free rate)
Description
stone free rate/
Time Frame
3 month

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 have 2-3 cm kidney stones patients who are between 18-90 years old Exclusion Criteria: patients who have congenital urogenital abnormalities patients who have previous surgery history for urinary stones
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
Ministry of Health, Turkey
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.B.Dıskapı 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
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Comparison of Safety and Efficiency of 20w and 30w Holmium Laser Device in Management of 2-3 cm Diameter Kidney Stones With Retrograde Intrarenal Surgery

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