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.
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
Current or history of pelvic radiation
Retroperitoneal fibrosis
Untreated urinary tract infection (UTI) within 30 days prior to RCIC
Pregnancy
Parallel
Ureteral Stent Placement
Procedure/SurgeryPlacement 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
Procedure/SurgeryRadical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.
Indocyanine Green with Fluorescence Imaging
Diagnostic testIndocyanine 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.
Number of urinary tract infection (UTI)
UTI is defined as clinical symptoms consistent with UTI as well as a positive urine culture showing ≥ 10⁵ CFU/mL of a uropathogen. Subjects who do not complete the 90-day follow-up period but had no evidence of infection at last follow-up will be excluded from the analysis. the Mantel-Haenszel stratified-adjusted estimate of the risk difference for incidence of urinary tract infection (risk in no stent arm - risk in stent arm) will be estimated along with one-sided (upper bound) 80% confidence interval.
Incidence of urinary leak
Measurement will be the presence or absence of a urinary leak. Urinary leak will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP/CMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with a urinary leak within the time frame.
Incidence of ureteral stricture
Measurement will be the presence or absence of ureteral stricture. Ureteral stricture will be identified through clinical symptoms, laboratory abnormalities, or imaging findings. Relevant assessments include vitals, laboratory testing (CBC and BMP/CMP), urinalysis, and imaging reports. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.
Incidence of readmission
Measurement will be the presence or absence of hospital readmission. Readmission is defined as any unplanned hospital admission during follow-up. Assessments include vitals, adverse event review, labs, urinalysis, and imaging performed at the scheduled post-operative visits. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.
Incidence of secondary intervention or procedure related to UTI or Urine Leak or Ureteral Stricture
Measurement will be the presence or absence of secondary intervention or procedure related to UTI or Urine Leak or Ureteral Stricture. These will be identified through hospital readmissions. Readmission is defined as any unplanned hospital admission during follow-up. Assessments include vitals, adverse event review, labs, urinalysis, and imaging performed at the scheduled post-operative visits. Data will be aggregated as the number and percentage of participants with ureteral stricture within the time frame.
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