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Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03108053
Enrollment
250
Registered
2017-04-11
Start date
2014-06-01
Completion date
2020-01-01
Last updated
2019-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Stone

Keywords

urinary stones, semirigid ureteroscopy, guidewire

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.

Interventions

PROCEDURESemirigid 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.

DEVICESemirigid 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.

Sponsors

Marmara University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Stone free ratesPost operative 3 months (12 weeks after surgery)

Secondary

MeasureTime frame
Operation duration of surgerythe duration of surgical procedure
Late Complication ratePost operative 3 months (12 weeks after surgery)
Early Complication ratePost operative 3 days (up to 3 days after surgery)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026