RecruitingNot ApplicableNCT07234968

Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy

Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy


Sponsor

Thomas Jefferson University

Enrollment

70 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical techniques during bladder removal surgery (cystectomy) — using a small internal tube called a ureteral stent versus not using one — to see which approach leads to better recovery outcomes. **You may be eligible if...** - You are between 18 and 85 years old - You have been diagnosed with bladder cancer or another pelvic cancer that requires complete bladder removal with a urinary diversion (a new way to drain urine, called an ileal conduit) - You are willing to follow the study procedures **You may NOT be eligible if...** - You have had pelvic radiation therapy (now or in the past) - You have a condition called retroperitoneal fibrosis (scarring around the urinary tract) - You have an untreated urinary tract infection within the past 30 days - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUreteral Stent Placement

Placement of ureteral stents (double J or single J) intraoperatively during radical cystectomy with ileal conduit urinary diversion (RCIC). Stent placement will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon.

PROCEDURENo Ureteral Stent

Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.

DIAGNOSTIC_TESTIndocyanine Green with Fluorescence Imaging

Indocyanine green (ICG) with fluorescence imaging is an advanced technique used to enhance the visualization of the ureters during complex pelvic surgeries, such as those for bladder cancer. The technology helps surgeons identify the ureters, which are the tubes connecting the kidneys to the bladder, and distinguish them from surrounding tissues.


Locations(2)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Jefferson Einstein Philadelphia Hospital

Philadelphia, Pennsylvania, United States

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NCT07234968


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