Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Not Applicable

• Conditions: Urinary Stone
• Interventions: Procedure: Semirigid Ureteroscopy (URS) With Guide Wire; Device: Semirigid Ureteroscopy (URS) Without Guide Wire

• Registration Number: NCT03108053
• Lead Sponsor: Marmara University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-17
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-12-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Ureteral stone disease patients who would undergo ureteroscopy procedure

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guidewire used	Semirigid Ureteroscopy (URS) With Guide Wire	Patients whose semirigid ureteroscopy procedure is conducted with the use of safety guidewire
No guide wire used	Semirigid Ureteroscopy (URS) Without Guide Wire	Patients whose semirigid ureteroscopy procedure is conducted without the use of safety guidewire

Primary Outcome Measures

Name	Time	Method
Stone free rates	Post operative 3 months (12 weeks after surgery)

Secondary Outcome Measures

Name	Time	Method
Early Complication rate	Post operative 3 days (up to 3 days after surgery)
Operation duration of surgery	the duration of surgical procedure
Late Complication rate	Post operative 3 months (12 weeks after surgery)

Trial Locations

Locations (1)

Marmara University School of Medicine; 🇹🇷 Pendik, Turkey