IMPACT - Introduction of Mycotic Prophylaxis At Cystectomy Trial Perioperative Antifungal Prophylaxis to Reduce Postoperative Complications After Cystectomy A Double-blinded, Placebo-controlled, Randomized Study

What this Trial Is About

Researchers are evaluating the impact of adding antifungal prophylaxis during surgery for patients undergoing cystectomy, which is the surgical removal of the urinary bladder with creation of a urinary diversion. This major cancer surgery often uses an ileal conduit, where part of the small intestine is used to divert urine. The study aims to see if antifungal medicine reduces postoperative complications caused by infections and local inflammation after surgery. Participants will receive either a single intravenous dose of Fluconazole (400 mg in 200 ml saline) or a placebo dose of intravenous saline solution (200 ml) during the perioperative period. The study is randomized, double-blinded, and placebo-controlled to compare the effects of antifungal prophylaxis added to standard antibiotic treatment. The trial includes only patients having cystectomy with urinary diversion by ileal conduit. During the 90 days following surgery, researchers will monitor postoperative complications, hospital stay length, gastrointestinal recovery, readmission rates, and patient quality of life using specific questionnaires before and after surgery. Safety and effectiveness of the antifungal prophylaxis will be assessed through these outcomes, with follow-up visits and evaluations to track recovery and complications.

Introduction of Mycotic Prophylaxis At Cystectomy Trial.