Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery

November 22, 2024 updated by: Ziho Lee, Northwestern University

Study to Assess Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery

Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

25

Contacts and Locations

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

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Ziho Lee, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects over 18 years of age undergoing surgery to fix the ureter.

Description

Inclusion Criteria:

  • >18 years of age
  • Undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest
  • Willing to sign informed consent form
  • Able to read and understand informed consent form

Exclusion Criteria:

  • <18 years of age
  • Inability to provide informed consent
  • Members of vulnerable patient populations

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Endoscopic Evaluation
Antegrade and retrograde pyelogram will be completed prior to definitive ureteral repair
Procedure: Antegrade and retrograde pyelogram
Participation in the study will guarantee that participants will receive this procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ureteral stricture length measured by antegrade or retrograde pyelogram
Time Frame: 2 weeks and 6 weeks post procedure
2 weeks and 6 weeks post procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
Ureteral Stricture Quality will be graded as either narrowed or obliterated segment.
Time Frame: 2 weeks and 6 weeks post procedure
2 weeks and 6 weeks post procedure

Collaborators and Investigators

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

Sponsor

Northwestern 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)

September 24, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 22, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00219828

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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