Clinical Research Directory

Prophylactic Antibiotics in Cystectomy With Diversion

Using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.

Ostomy Simulation for Patient Education Prior to Urologic Bowel Diversion Surgeries

The purpose of this study is to evaluate the feasibility of using a realistic and anatomically accurate 3D printed simulation model for urologic bowel diversion patient education. Using a randomized two group design, we aim to determine whether the use of this model enhances patient knowledge, self-care skills, and confidence in ostomy care. We will also evaluate changes in quality of life (QOL) and patient satisfaction comparing patients exposed to the 3D model to those receiving standard of care. The secondary aim of the study is to examine the differences between groups on patient outcomes including hospital duration, mortality, emergency/urgent health care visits, readmissions, and infections. Participants will be educated using 3D model simulation as part of their preoperative education (experimental group) or have standard education without using the simulation model (comparator group). Both groups will complete quality of life (QOL), ostomy adjustment, and satisfaction with education surveys during their preoperative education visit and again during their routine follow-up visits (a) within 3 weeks after surgery, (b) between 5- 8 weeks after surgery, and (c) at approximately 3 months after surgery.

A Feasibility Randomized Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer

Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve positive outcomes. The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, stage, presence of CIS and age (Carcinoma in Situ). The optimal treatment of MIBC (T2-T4N0M0) consists of neoadjuvant cisplatin-based chemotherapy followed by Radical cystectomy and urinary diversion (RCUD). In the last couple of decades, RCUD has also gained attention for treating patients with high-risk non-muscle invasive bladder cancer. Despite advancements in surgical techniques and the rise of minimally invasive alternatives, complications after surgery remain frequent, with morbidity rates of approximately 50%. Several uncertainties persist in surgical practice, including the role of perioperative ureteric stenting during RCUD. Perioperative ureteric stenting is intended to minimize urinary leakage from the newly created uretero-enteric anastomosis and to prevent early obstruction caused by anastomotic swelling. However, stenting may increase the risk of urinary tract infections (UTIs) and necessitate additional follow-up for stent removal. Peng et al. conducted the most recent systematic review in 2021, demonstrating that ureteral stents in RCUD were linked to higher rates of anastomotic strictures. Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage. The review underscored the scarcity of prospective randomized controlled trials examining the safety and effectiveness of stenting in this context. The sole prospective (non-randomized) study assessing stent dwell / retention time after RCUD demonstrated early stent removal (2 weeks) had decreased 90-day readmissions and UTIs. Therefore, the investigators aimed to determine the feasibility of conducting a definitive randomized trial to evaluate patients undergoing radical cystectomy and ileal conduit formation to receive either early stent removal (5-7 days) or late stent removal (4-6 weeks).

Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis

The aim of this trial is to test whether postoperative antibiotics targeted towards bacteria in the urine can reduce the risk of infection after surgical removal of the bladder (cystectomy) compared to a standardised antibiotic prophylaxis. Participants undergoing cystectomy will be randomly assigned to postoperatively receive (A) a standardised orally administered antibiotic prophylaxis currently given at Rigshospitalet, Copenhagen or (B) a conventional orally administered antibiotic prophylaxis targeting bacteria found in the urine postoperatively. The investigators' hypothesis is that the targeted prophylactic antibiotic strategy will reduce the number of infection-related readmissions within 90 days of surgery compared to the standardised prophylaxis.