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
Thomas Jefferson University
70 participants
Dec 23, 2025
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
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
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.
Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.
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)
View Full Details on ClinicalTrials.gov
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NCT07234968