Optimal Passive Dilation Time in Retrograde Intrarenal Surgery

April 20, 2022 updated by: Ali Kaan Yildiz, Ankara Training and Research Hospital
Retrograde intrarenal surgery (RIRC) is used as standard treatment for stones less than 2 cm. In some cases, the ureteral access sheath cannot be placed due to ureteral stricture. In this case, a double j stent (DJ) is placed to passively dilate the ureter, and the RIRC is postponed for post-dilatation. The aim of the study is to determine the optimal time for RIRC operation in cases where a double j stent was placed for passive dilatation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a DJ stent for passive dilatation and subsequent RIRC

Description

Inclusion Criteria:

  • Patients with a DJ stent for passive dilatation and subsequent RIRC

Exclusion Criteria:

  • Urinary tract infection, patients with ureteral compression and a history of pelvic radiotherapy, urinary system tumor

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

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation
Procedure: Retrograde intrarenal surgery after DJ stent placement
Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation
Patients who underwent RIRC for 4-6 weeks after DJ stent placement for passive dilatation
Procedure: Retrograde intrarenal surgery after DJ stent placement
Patients who underwent RIRC for 2-4 weeks after DJ stent placement for passive dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BMI in kg/m^2
Time Frame: 3 Months
BMI in kg/m^2the kidney, operation time(minute)
3 Months
serum creatinine mg/dl
Time Frame: 3 Months
serum creatinine mg/dl
3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mm size of the stone
Time Frame: 3 Months
mm size of the stone
3 Months
localization of the stone in the kidney,
Time Frame: 3 Months
localization of the stone in the kidney,
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 (Actual)

September 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DJRIRS2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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