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Recruiting NCT07234968

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

Trial Parameters

Condition Bladder Cancer
Sponsor Thomas Jefferson University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age 85 Years
Start Date 2025-12-23
Completion 2028-04-30
Interventions
Ureteral Stent PlacementNo Ureteral StentIndocyanine Green with Fluorescence Imaging

Brief 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 Criteria

Inclusion Criteria: * Individuals must meet all the following inclusion criteria to be eligible to participate in the study: * Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female, age 18 to 85 * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: * Current or history of pelvic radiation * Retroperitoneal fibrosis * Untreated urinary tract infection (UTI) within 30 days prior to RCIC * Pregnancy

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