IMPACT-Introduction of Mycotic Prophylaxis At Cystectomy Trial: perioperative mycotic prophylaxis with fluconazole to reduce postoperative complications following cystectomy-study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial
Abstract
Introduction and objectives: Cystectomy with urinary diversion is one of the most complex surgeries in the urological specialty involving surgery on multiple organ systems. The postoperative risk of mortality and complications is considerable, and the first months after surgery are often the most critical. When creating the urinary diversion, the abdominal cavity is exposed to bacteria and fungus from the small intestine, and after the surgery, micro-leakage from the intestinal anastomosis may also contribute to a local infectious response. This contamination is suspected to increase the risk of bowel paralysis that, even with modern ERAS protocols, significantly impacts the postoperative recovery. Emerging data show that approximately 50% of the patients undergoing cystectomy have Candida albicans in samples from the terminal ileum. Current guidelines support the use of perioperative antibiotics, but there are currently no guidelines on antimycotic prophylaxis. We present a randomized clinical trial that tests whether incorporating antimycotics into the perioperative antimicrobial prophylactic regimen can reduce major complications after cystectomy.
Materials and methods: This is a multi-center, double-blinded, randomized clinical trial including participants from all five centers in Denmark performing cystectomy. The study includes adult patients planned for cystectomy with an ileal conduit with no contraindications to fluconazole and no active treatment for mycotic…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 420 participants or records.
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