Prophylactic Antibiotics in Radical Cystectomy With Urinary Diversion

What this Trial Is About

Researchers are evaluating the use of prophylactic antibiotics versus no antibiotics after surgery in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion. This early phase 1 trial tests whether not using preventive antibiotics is not worse than using the antibiotic nitrofurantoin in preventing urinary tract infections during the 90-day period after surgery. The study compares infection rates between those who receive antibiotics and those who do not to understand the best approach for managing infection risk after this surgery. Participants are randomly assigned to one of two groups: one group receives no prophylactic antibiotics after surgery and only takes antibiotics if an infection occurs, while the other group takes nitrofurantoin daily after surgery for either 10 or 21 days depending on the type of urinary diversion (ileal conduit or orthotopic neobladder). Participants are instructed on how to take the antibiotic capsules properly, including handling missed doses. The study is designed with a single-blind approach and follows participants for outcomes over the 90 days after surgery. During the study, researchers will monitor participants for urinary tract infections and other outcomes at 30 and 90 days postoperatively to compare infection risks between the two groups. Participants will have regular follow-ups to assess their health status and any infections. The primary outcome is measuring the difference in infection risk to determine if no antibiotics is not inferior to prophylactic antibiotic use after radical cystectomy. The total study duration extends through the 90-day postoperative period with safety and infection monitoring.

Prophylactic Antibiotics in Cystectomy With Diversion