IMPACT Trial: Studying Perioperative Fluconazole to Reduce Postoperative Complications After Cystectomy with Urinary Diversion A Double-Blinded, Placebo-Controlled, Randomized Study

What this Trial Is About

This research aims to evaluate the effect of adding antifungal prophylaxis for patients undergoing cystectomy, a major surgery to remove the urinary bladder and create a urinary diversion. The study focuses on reducing complications after surgery, especially infections and bowel problems like paralytic ileus, which can prolong recovery and increase risks such as pneumonia and wound issues. Cystectomy involves exposure of the abdominal cavity to bacteria and fungi from the ileum, and current antibiotic treatments may not fully address fungal infections that are common in these patients. Participants will receive either a single intravenous dose of 400 mg fluconazole, an antifungal medication, or a placebo of isotonic saline solution during the perioperative period. This double-blinded, placebo-controlled, randomized trial compares the addition of antifungal prophylaxis alongside standard antibiotic treatments to assess whether it reduces postoperative complications. The study specifically includes patients receiving an ileal conduit urinary diversion after cystectomy. During the study, researchers will monitor patients for postoperative complications up to 90 days after surgery. Assessments will include tracking infections and other surgery-related issues to determine the impact of antifungal prophylaxis. Participants will be followed to observe safety and effectiveness outcomes, providing data on potential benefits of adding antifungal treatment to standard care in this complex surgery.

Introduction of Mycotic Prophylaxis At Cystectomy Trial.