Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2020-01-01

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.

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Detailed Description

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Conditions

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Urinary Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Guidewire used

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

Group Type ACTIVE_COMPARATOR

Semirigid Ureteroscopy (URS) With Guide Wire

Intervention Type PROCEDURE

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.

No guide wire used

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

Group Type EXPERIMENTAL

Semirigid Ureteroscopy (URS) Without Guide Wire

Intervention Type DEVICE

Semirigid URS is the operations used for ureteral stone disease . It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.

Interventions

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Semirigid Ureteroscopy (URS) With Guide Wire

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.

Intervention Type PROCEDURE

Semirigid Ureteroscopy (URS) Without Guide Wire

Semirigid URS is the operations used for ureteral stone disease . It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No