Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Urinary Stone Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03108053
• Other study ID #: MAR.UAD.001
• Secondary ID: 09.2017.098
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2014
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2019
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Urinary Calculi
• Urinary Stone
• Urolithiasis

Intervention

Procedure:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Marmara University School of Medicine	Pendik

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone free rates		Post operative 3 months (12 weeks after surgery)
Secondary	Operation duration of surgery		the duration of surgical procedure
Secondary	Late Complication rate		Post operative 3 months (12 weeks after surgery)
Secondary	Early Complication rate		Post operative 3 days (up to 3 days after surgery)