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Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone

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ClinicalTrials.gov Identifier: NCT03726502
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Hamidreza Shemshaki, Isfahan University of Medical Sciences

Brief Summary:
The purpose of this study is to compare ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

Condition or disease Intervention/treatment Phase
Ureteral Calculi Procedure: ureteroscopy with safety guide-wire Procedure: ureteroscopy alone Procedure: without safety guide-wire Procedure: with safety guide-wire Not Applicable

Detailed Description:
While there are some retrospective studies compared ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone, there is not randomized clinical trial in this regard. This study was designed to compare the efficacy and safety of ureteroscopy with and without use of safety guide-wire in treatment of ureteral stone

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing Uretersocopy With Versus Without Use of Guide-wire in Treatment of Ureteral Stone
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : April 1, 2017
Actual Study Completion Date : April 1, 2017

Arm Intervention/treatment
Active Comparator: ureteroscopy with safety guide-wire
ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy
Procedure: ureteroscopy with safety guide-wire
ureteroscopy with use of safety guide-wire in treatment of ureteral stone

Procedure: with safety guide-wire
ureteroscopy with use of safety guide-wire in treatment of ureteral stone

Placebo Comparator: ureteroscopy alone
ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy
Procedure: ureteroscopy alone
ureteroscopy without use of safety guide-wire in treatment of ureteral stone

Procedure: without safety guide-wire
ureteroscopy without use of safety guide-wire in treatment of ureteral stone

Active Comparator: with safety guide-wire
ureteroscopy is done with use of safety guide-wire, this is a one procedure that we use safety guide wire (as a device) during ureteroscopy
Procedure: ureteroscopy with safety guide-wire
ureteroscopy with use of safety guide-wire in treatment of ureteral stone

Procedure: with safety guide-wire
ureteroscopy with use of safety guide-wire in treatment of ureteral stone

Placebo Comparator: without safety guide-wire
ureteroscopy is done without use of safety guide-wire, this is a one procedure that we don"t use safety guide wire (as a device) during ureteroscopy
Procedure: ureteroscopy alone
ureteroscopy without use of safety guide-wire in treatment of ureteral stone

Procedure: without safety guide-wire
ureteroscopy without use of safety guide-wire in treatment of ureteral stone




Primary Outcome Measures :
  1. stone free rate [ Time Frame: 3 months after surgery ]
    rate of patients without any residue of stone


Secondary Outcome Measures :
  1. operation time [ Time Frame: at time of surgery ]
    the time between insertion of ureteroscopy till insertion of catheter

  2. grade of kidney hydronephrosis [ Time Frame: 3 months after surgery ]
    grade of hydronephrosis is classified as: 0-4 grades

  3. ureteral injury [ Time Frame: at time of surgery ]
    ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ureteral stone who underwent ureteroscopy

Exclusion Criteria:

  • transplant kidney
  • coagulopathy disorders
  • history of ureteral stenosis
  • skeletal disorders

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): NCT03726502


Locations
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Iran, Islamic Republic of
Shahid beheshty university of medical sciences
Tehrān, Iran, Islamic Republic of
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Chair: Abbas Basiri, prof Shahid beheshty university of medical sciences

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Responsible Party: Hamidreza Shemshaki, Director, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03726502     History of Changes
Other Study ID Numbers: Q12133
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hamidreza Shemshaki, Isfahan University of Medical Sciences:
Ureteral Calculi
safety guide-wire
ureteroscopy
Additional relevant MeSH terms:
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Ureteral Calculi
Ureterolithiasis
Calculi
Pathological Conditions, Anatomical
Ureteral Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi