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

Phase 4

• Conditions: Nephrolithiasis
• Interventions: Procedure: Retrograde Intrarenal Surgery; Device: Holmium laser device

• Registration Number: NCT02443909
• Lead Sponsor: Diskapi Teaching and Research Hospital

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-04-28
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-13
• Last Update Submitted: 2015-05-13
• Study First Posted: 2015-05-14
• Last Update Posted: 2015-05-14
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
second group	Retrograde Intrarenal Surgery	Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones
first group	Holmium laser device	Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones
second group	Holmium laser device	Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones
first group	Retrograde Intrarenal Surgery	Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones
third group	Retrograde Intrarenal Surgery	Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston
third group	Holmium laser device	Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston

Primary Outcome Measures

Name	Time	Method
Safety (Complications according to clavien system)	1 day	Complications according to clavien system
Efficiency (visual analog score)	1 Day	visual analog score

Secondary Outcome Measures

Name	Time	Method
Efficiency (stone free rate)	3 month	stone free rate/

Trial Locations

Locations (1)

S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital; 🇹🇷 Ankara, Turkey