Back to results

Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Primary Purpose

Urinary Stone

Status

Unknown status

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Semirigid Ureteroscopy (URS) With Guide Wire

Semirigid Ureteroscopy (URS) Without Guide Wire

About this trial

This is an interventional treatment trial for Urinary Stone focused on measuring urinary stones, semirigid ureteroscopy, guidewire

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Marmara University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Guidewire used

No guide wire used

Arm Description

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

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

Outcomes

Primary Outcome Measures

Stone free rates

Secondary Outcome Measures

Operation duration of surgery

Late Complication rate

Early Complication rate

Full Information

NCT ID

NCT03108053

First Posted

March 10, 2017

Last Updated

March 17, 2019

Sponsor

Marmara University

1. Study Identification

Unique Protocol Identification Number

NCT03108053

Brief Title

Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2014 (Actual)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

January 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Marmara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Stone

Keywords

urinary stones, semirigid ureteroscopy, guidewire

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Guidewire used

Arm Type

Active Comparator

Arm Description

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

Arm Title

No guide wire used

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Semirigid Ureteroscopy (URS) With Guide Wire

Intervention Description

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

Device

Intervention Name(s)

Semirigid Ureteroscopy (URS) Without Guide Wire

Intervention Description

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

Primary Outcome Measure Information:

Title

Stone free rates

Time Frame

Post operative 3 months (12 weeks after surgery)

Secondary Outcome Measure Information:

Title

Operation duration of surgery

Time Frame

the duration of surgical procedure

Title

Late Complication rate

Time Frame

Post operative 3 months (12 weeks after surgery)

Title

Early Complication rate

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Marmara University School of Medicine

City

Pendik

Country

Turkey

Individual Site Status

Recruiting

Facility Contact: