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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Individuals must meet all the following inclusion criteria to be eligible to participate in the study: - Provide signed and dated willing to sign a consent form 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

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.

PROCEDURE

No Ureteral Stent

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

DIAGNOSTIC_TEST

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