Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy
About this study
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.
- Condition
- Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma, Pelvic Malignancy, Bladder Transitional Cell Carcinoma, Bladder Neoplasm
- Tested
- Ureteral Stent Placement, No Ureteral Stent, Indocyanine Green with Fluorescence Imaging
- Sponsor
- Thomas Jefferson University
Who can join
- Age
- 18 to 85 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 8
- Minimum age: 18 years
- Maximum age: 85 years
- Study condition: Bladder Cancer, Muscle-Invasive Bladder Carcinoma, Urothelial Carcinoma, Pelvic Malignancy, Bladder Transitional Cell Carcinoma, Bladder Neoplasm
- 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 5
- 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
Where
2 sites, 2 recruiting
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Jefferson Einstein Philadelphia Hospital
Philadelphia, Pennsylvania, United States
Contact
-
Mihir S Shah, MD
215-955-6961 Mihir.Shah@jefferson.edu
Potential match only. Final eligibility is determined by the study team.