Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Study Overview
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Brief Summary
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Up-to-date, urology guidelines introduce safety guidewire (SGW) as an integral tool in ureteroscopy and recommended its routine use. However, the necessity of SGW placement in endourological procedures lack evidence and is being suggested as an expert opinion. Present study aimed to evaluate the use of SGW placement and its necessity in treatment of ureteral stones with semi-rigid ureteroscopy (s-URS). For this purpose patients with ureteral stones are being stratified according to ureteral stone location and prospectively randomized into two groups' according to SGW usage or not in s-URS. Ureteroscopy and litotripsy is being done with a semi-rigid ureteroscope of 6.4/7.8 Fr (Olympus) and laser. Chi-square and student t-test were used for comparing data.

Official Title
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Results of a Prospective Randomized Trial of Safety Guidewire Use in Ureteroscopic Stone Surgery: to Use or Not to Use

Conditions
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Urinary Stone

Intervention / Treatment
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* Procedure: Semirigid Ureteroscopy (URS) With Guide Wire
* Device: Semirigid Ureteroscopy (URS) Without Guide Wire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ureteral stone disease patients who would undergo ureteroscopy procedure Exclusion Criteria: Patients who have a medical condition that makes randomisation not possible Patients in whose operations safety guidewire is regarded as a necessity Patients who refuse to participate

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Guidewire used<br>Patients whose semirigid ureteroscopy procedure is conducted with the use of safety guidewire | Procedure: Semirigid Ureteroscopy (URS) With Guide Wire<br>* Semirigid URS is the operations used for ureteral stone disease. In routine practice it is most commonly done with the use of a guide wire. It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.<br>|
| Experimental: No guide wire used<br>Patients whose semirigid ureteroscopy procedure is conducted without the use of safety guidewire | Device: Semirigid Ureteroscopy (URS) Without Guide Wire<br>* Semirigid URS is the operations used for ureteral stone disease . It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone free rates |  | Post operative 3 months (12 weeks after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation duration of surgery |  | the duration of surgical procedure | 
| Late Complication rate |  | Post operative 3 months (12 weeks after surgery) | 
| Early Complication rate |  | Post operative 3 days (up to 3 days after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary stones, semirigid ureteroscopy, guidewire