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Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
Sponsor: Thomas Jefferson University
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.
Official title: Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2025-12-23
Completion Date
2028-04-30
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Ureteral 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.
No Ureteral Stent
Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.
Indocyanine 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