Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs No Ureteral Stent in Radical Cystectomy with Ileal Conduit Urinary Diversion

What this Trial Is About

Researchers are evaluating the outcomes of using ureteral stents versus not using them during radical cystectomy with ileal conduit urinary diversion (RCIC) in patients with muscle invasive bladder cancer and other pelvic malignancies. This randomized controlled trial aims to compare the risk of post-operative complications between these two approaches, which are both considered standard care for this condition. The study will monitor patients for 12 months following surgery to understand these outcomes better. Participants will be randomly assigned to one of two groups: one group will have ureteral stents placed during their RCIC surgery, which will be removed 7 to 21 days after surgery depending on the surgeon's decision; the other group will undergo the same surgery without stent placement. The surgical approach may be open, robotic, or hybrid, and indocyanine green with fluorescence imaging may be used to help identify the ureters during surgery. Both groups will receive standard care throughout the study period. After surgery, patients will have scheduled follow-up visits at around 30 days, 3 months, 6 months, and 12 months to monitor their recovery and complications. These visits may include assessments for urinary tract infections, urinary leaks, and ureteral strictures. Additional visits may occur if stents, catheters, or nephrostomies need replacement or if surgical repair is required. The primary outcome measured is the number of urinary tract infections within 90 days after surgery, with secondary outcomes including urinary leaks and strictures. Participants will be followed for up to one year or until death.

Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy