NCT05265936

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

March 4, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

February 22, 2022

Last Update Submit

March 2, 2022

Conditions

Keywords

double j stentguidewireinfection

Outcome Measures

Primary Outcomes (1)

  • Rate of postoperative complication

    Rate of patients who had a postoperative complication

    3 months

Study Arms (2)

Guidewire through DJ stent

ACTIVE COMPARATOR

Patients who underwent lithotripsy after guidewire insertion through a previously placed double j stent.

Procedure: Passing a guidewire through a double j stent

DJ stent remove + guidewire

SHAM COMPARATOR

Patients who underwent lithotripsy after double j stent removal and guidewire placement.

Procedure: Double J stent removal and guidewire insertion

Interventions

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.

Guidewire through DJ stent

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.

DJ stent remove + guidewire

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Double J stent placed at least 2 weeks ago

You may not qualify if:

  • Active urinary tract infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

Location

Related Publications (1)

  • Leslie SW, Sajjad H. Double J Placement Methods Comparative Analysis. 2023 May 30. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482453/

    PMID: 29494060BACKGROUND

MeSH Terms

Conditions

Kidney CalculiUreteral ObstructionInfections

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreteral Diseases

Study Officials

  • Ali Kaan Yildiz

    Ankara Training and Resarch Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 22, 2022

First Posted

March 4, 2022

Study Start

March 1, 2022

Primary Completion

June 1, 2022

Study Completion

July 1, 2022

Last Updated

March 4, 2022

Record last verified: 2022-03

Locations