Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

NCT03108053 | Unknown

• 2 other identifiers: MAR.UAD.00109.2017.098
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Stone

Keywords

urinary stones; semirigid ureteroscopy; guidewire

Outcome Measures

Primary Outcomes (1)

• Stone free rates

  Post operative 3 months (12 weeks after surgery)

Secondary Outcomes (3)

• Operation duration of surgery

  the duration of surgical procedure

• Late Complication rate

  Post operative 3 months (12 weeks after surgery)

• Early Complication rate

  Post operative 3 days (up to 3 days after surgery)

Study Arms (2)

Guidewire used

ACTIVE COMPARATOR

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

Procedure: Semirigid Ureteroscopy (URS) With Guide Wire

No guide wire used

EXPERIMENTAL

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

Device: Semirigid Ureteroscopy (URS) Without Guide Wire

Interventions

Semirigid Ureteroscopy (URS) With Guide Wire 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.

Guidewire used

Semirigid Ureteroscopy (URS) Without Guide Wire DEVICE

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

No guide wire used

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ureteral stone disease patients who would undergo ureteroscopy procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University School of Medicine

Pendik, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Condition Hierarchy (Ancestors)

Urolithiasis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 11, 2017
• Study Start: June 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)