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

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

Detailed Description
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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

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

Conditions
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Ureteral Calculi

Intervention / Treatment
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* Procedure: ureteroscopy with safety guide-wire
* Procedure: ureteroscopy alone
* Procedure: without safety guide-wire
* Procedure: with safety guide-wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ureteral stone who underwent ureteroscopy Exclusion Criteria: transplant kidney coagulopathy disorders history of ureteral stenosis skeletal disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ureteroscopy with safety guide-wire<br>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<br>* ureteroscopy with use of safety guide-wire in treatment of ureteral stone<br>Procedure: with safety guide-wire<br>* ureteroscopy with use of safety guide-wire in treatment of ureteral stone<br>|
| Placebo Comparator: ureteroscopy alone<br>ureteroscopy is done without use of safety guide-wire, this is a one procedure that we dont use safety guide wire (as a device) during ureteroscopy | Procedure: ureteroscopy alone<br>* ureteroscopy without use of safety guide-wire in treatment of ureteral stone<br>Procedure: without safety guide-wire<br>* ureteroscopy without use of safety guide-wire in treatment of ureteral stone<br>|
| Active Comparator: with safety guide-wire<br>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<br>* ureteroscopy with use of safety guide-wire in treatment of ureteral stone<br>Procedure: with safety guide-wire<br>* ureteroscopy with use of safety guide-wire in treatment of ureteral stone<br>|
| Placebo Comparator: without safety guide-wire<br>ureteroscopy is done without use of safety guide-wire, this is a one procedure that we dont use safety guide wire (as a device) during ureteroscopy | Procedure: ureteroscopy alone<br>* ureteroscopy without use of safety guide-wire in treatment of ureteral stone<br>Procedure: without safety guide-wire<br>* ureteroscopy without use of safety guide-wire in treatment of ureteral stone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | rate of patients without any residue of stone | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | the time between insertion of ureteroscopy till insertion of catheter | at time of surgery | 
| grade of kidney hydronephrosis | grade of hydronephrosis is classified as: 0-4 grades | 3 months after surgery | 
| ureteral injury | ureteral injury is classified as: Mucosal abrasion, Ureteral perforation, Intussusception / avulsion | at time of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral Calculi, safety guide-wire, ureteroscopy