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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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ClinicalTrials.gov Identifier: NCT02443909
Recruitment Status : Unknown
Verified May 2015 by Nihat Karakoyunlu, Diskapi Teaching and Research Hospital.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Nihat Karakoyunlu, 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).

Condition or disease Intervention/treatment Phase
Nephrolithiasis Procedure: Retrograde Intrarenal Surgery Device: Holmium laser device Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones
Drug Information available for: Holmium

Arm Intervention/treatment
Active Comparator: first group
Patients undergoing Retrograde Intrarenal Surgery with 20w Holmium laser device who have 2-3 cm kidney stones
Procedure: Retrograde Intrarenal Surgery
endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
Other Name: RIRS

Device: Holmium laser device
Active Comparator: second group
Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power) who have 2-3 cm kidney stones
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
Other Name: RIRS

Device: Holmium laser device
Active Comparator: third group
Patients undergoing Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power) who have 2-3 cm kidney ston
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Other Name: RIRS

Device: Holmium laser device



Primary Outcome Measures :
  1. Safety (Complications according to clavien system) [ Time Frame: 1 day ]
    Complications according to clavien system

  2. Efficiency (visual analog score) [ Time Frame: 1 Day ]
    visual analog score


Secondary Outcome Measures :
  1. Efficiency (stone free rate) [ Time Frame: 3 month ]
    stone free rate/



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02443909


Contacts
Contact: Nihat Karakoyunlu, MD 00905324747134 nkarakoyunlu@gmail.com

Locations
Turkey
S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital Recruiting
Ankara, Turkey, 06110
Contact: Nihat Karakoyunlu, MD    00905324747134    nkarakoyunlu@gmail.com   
Principal Investigator: Nihat Karakoyunlu, MD         
Sponsors and Collaborators
Diskapi Teaching and Research Hospital
Investigators
Principal Investigator: Nihat Karakoyunlu, MD Ministry of Health, Turkey

Publications of Results:
Responsible Party: Nihat Karakoyunlu, MD, Diskapi Teaching and Research Hospital
ClinicalTrials.gov Identifier: NCT02443909     History of Changes
Other Study ID Numbers: 26.01.2015
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

Keywords provided by Nihat Karakoyunlu, Diskapi Teaching and Research Hospital:
Holmium Laser
Kidney Stones
RIRS

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical