Back to resultsIs it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?
Primary Purpose
Kidney Stone, Ureter Obstruction, Stent Complication
Status
Not yet recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Passing a guidewire through a double j stent
Double J stent removal and guidewire insertion
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Stone focused on measuring double j stent, guidewire, infection
Eligibility Criteria
Inclusion Criteria:
- Double J stent placed at least 2 weeks ago
Exclusion Criteria:
- Active urinary tract infection
Sites / Locations
- Ankara Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Guidewire through DJ stent
DJ stent remove + guidewire
Arm Description
Patients who underwent lithotripsy after guidewire insertion through a previously placed double j stent.
Patients who underwent lithotripsy after double j stent removal and guidewire placement.
Outcomes
Primary Outcome Measures
Rate of postoperative complication
Rate of patients who had a postoperative complication
Secondary Outcome Measures
Full Information
NCT ID
NCT05265936
First Posted
February 22, 2022
Last Updated
March 2, 2022
Sponsor
Ankara Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05265936
Brief Title
Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?
Official Title
Is it Safe to Advance a Guidewire Through a Previously Deployed Double j Stent? A Prospective, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Ureter Obstruction, Stent Complication
Keywords
double j stent, guidewire, infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guidewire through DJ stent
Arm Type
Active Comparator
Arm Description
Patients who underwent lithotripsy after guidewire insertion through a previously placed double j stent.
Arm Title
DJ stent remove + guidewire
Arm Type
Sham Comparator
Arm Description
Patients who underwent lithotripsy after double j stent removal and guidewire placement.
Intervention Type
Procedure
Intervention Name(s)
Passing a guidewire through a double j stent
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Double J stent removal and guidewire insertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of postoperative complication
Description
Rate of patients who had a postoperative complication
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Double J stent placed at least 2 weeks ago
Exclusion Criteria:
Active urinary tract infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Kaan Yildiz
Phone
+90 554 773 16 96
Email
alikaanyildiz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Esra Gulen Yildiz
Phone
+90 506 877 47 09
Email
esragln90@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Kaan Yildiz
Organizational Affiliation
Ankara Training and Resarch Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06230
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
29494060
Citation
Leslie SW, Sajjad H. Double J Placement Methods Comparative Analysis. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482453/
Results Reference
background
Learn more about this trial
Is it Safe to Advance a Guidewire Through a Previously Placed Double j Stent?
We'll reach out to this number within 24 hrs