Results of Safety Guidewire Use in Ureteroscopic Stone Surgery

March 17, 2019 updated by: Marmara University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Pendik, Turkey
        • Recruiting
        • Marmara University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yiloren Tanidir
        • Principal Investigator:
          • Bahadir Sahin
        • Sub-Investigator:
          • Muhammed Sulukaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Guidewire used
Patients whose semirigid ureteroscopy procedure is conducted with the use of safety guidewire
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.
Experimental: No guide wire used
Patients whose semirigid ureteroscopy procedure is conducted without the use of safety guidewire
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stone free rates
Time Frame: Post operative 3 months (12 weeks after surgery)
Post operative 3 months (12 weeks after surgery)

Secondary Outcome Measures

Outcome Measure
Time Frame
Operation duration of surgery
Time Frame: the duration of surgical procedure
the duration of surgical procedure
Late Complication rate
Time Frame: Post operative 3 months (12 weeks after surgery)
Post operative 3 months (12 weeks after surgery)
Early Complication rate
Time Frame: Post operative 3 days (up to 3 days after surgery)
Post operative 3 days (up to 3 days after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

March 10, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

March 19, 2019

Last Update Submitted That Met QC Criteria

March 17, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAR.UAD.001
  • 09.2017.098 (Other Identifier: Clinical Research Ethics Committee of Marmara University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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