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

May 13, 2015 updated by: Nihat Karakoyunlu, Diskapi Teaching and Research Hospital
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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Recruiting
        • S.B.Dıskapı Yıldırım Beyazıt Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • RIRS
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
Other Names:
  • RIRS
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Other Names:
  • 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
endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
Other Names:
  • RIRS
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
Other Names:
  • RIRS
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Other Names:
  • 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
endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
Other Names:
  • RIRS
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
Other Names:
  • RIRS
Procedure: Retrograde Intrarenal Surgery
Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
Other Names:
  • RIRS
Device: Holmium laser device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Complications according to clavien system)
Time Frame: 1 day
Complications according to clavien system
1 day
Efficiency (visual analog score)
Time Frame: 1 Day
visual analog score
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficiency (stone free rate)
Time Frame: 3 month
stone free rate/
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Principal Investigator: Nihat Karakoyunlu, MD, Ministry of Health, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

May 14, 2015

Last Update Submitted That Met QC Criteria

May 13, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26.01.2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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