Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?

March 2, 2022 updated by: Ali Kaan Yildiz, Ankara Training and Research Hospital

Is it Safe to Advance a Guidewire Through a Previously Deployed Double j Stent? A Prospective, Randomized, Controlled Study

In this prospective randomized controlled study, it is aimed to investigate the effects of guidewire advanced through a previously placed double j stent on postoperative complications, operation time and efficacy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

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
    • Altindag
      • Ankara, Altindag, Turkey, 06230
        • Ankara Training and Research Hospital

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Double J stent placed at least 2 weeks ago

Exclusion Criteria:

  • Active urinary tract infection

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Guidewire through DJ stent
Patients who underwent lithotripsy after guidewire insertion through a previously placed double j stent.
Procedure: Passing a guidewire through a double j stent
The previously placed double J stent is removed up to the urethral meatus with a cystoscope and forceps and kept fixed at the meatal level without further pulling. Then, after reaching the kidney by passing a guidewire through it, the double j stent is removed. Followed by the routine lithotripsy procedure.
Sham Comparator: DJ stent remove + guidewire
Patients who underwent lithotripsy after double j stent removal and guidewire placement.
Procedure: Double J stent removal and guidewire insertion
The double j stent is completely removed with the cystoscope and forceps, and the guidwire is inserted into the ureter by visualizing it with the cystoscope. Followed by the routine lithotripsy procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative complication
Time Frame: 3 months
Rate of patients who had a postoperative complication
3 months

Collaborators and Investigators

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

Sponsor

Ankara Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

March 1, 2022

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DJG2022

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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