Comparison of Safety and Efficiency of 20w 30w Holmium Laser Device in Treatment of 1-2 cm Diameter Kidney Stones With RIRS

May 20, 2015 updated by: Nihat Karakoyunlu, Diskapi Teaching and Research Hospital
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).

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
        • Tuekey Ministry of HealthDıskapı 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 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

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: SINGLE_GROUP
  • 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 1-2 cm diameter kidney stones
Procedure: Retrograde Intrarenal Surgery
Endoscopic treatment of Kidney Stones
Active Comparator: second group
Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser device (working over 20w power) who have 1-2 cm diameter kidney stones
Procedure: Retrograde Intrarenal Surgery
Endoscopic treatment of Kidney Stones
Active Comparator: third group
Patients undergoing Retrograde Intrarenal Surgery with 30w holmium laser(working under 20w power) device who have 1-2 cm diameter kidney stones
Procedure: Retrograde Intrarenal Surgery
Endoscopic treatment of Kidney Stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - complications according to clavien system
Time Frame: postoperative 24 hours
complications according to clavien system
postoperative 24 hours
safety - visual analog score
Time Frame: postoperative 24 hours
visual analog score
postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficiency - stone free rate
Time Frame: postoperative 24 hours
stone free rate post operative first day
postoperative 24 hours

Collaborators and Investigators

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

Sponsor

Diskapi Teaching and Research Hospital

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 20, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 20, 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 19/17

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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