Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Marmara University

Status: Unknown

Conditions: Urinary Stone

Treatments: Device: Semirigid Ureteroscopy (URS) Without Guide Wire; Procedure: Semirigid Ureteroscopy (URS) With Guide Wire

Study type: Interventional

Funder types: Other

Identifiers

NCT03108053

MAR.UAD.001

09.2017.098 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Guidewire used

Active Comparator group

Description:

Patients whose semirigid ureteroscopy procedure is conducted with the use of safety guidewire

Treatment:

Procedure: Semirigid Ureteroscopy (URS) With Guide Wire

No guide wire used

Experimental group

Description:

Patients whose semirigid ureteroscopy procedure is conducted without the use of safety guidewire

Treatment:

Device: Semirigid Ureteroscopy (URS) Without Guide Wire