IMPACT – the introduction of mycotic prophylaxis at cystectomy trial.

INTERVENTION: Product Name: Fluconazole Kabi 2mg/ml solution for infusion,Product Code: PRD10277156,Pharmaceutical Form: SOLUTION FOR INFUSION,Other descriptive name: ,Strength: Fluconazole 2mg,Product Name: Natriumklorid ”B. Braun”,Product Code: PRD563912,Pharmaceutical Form: SOLUTION FOR INJECTION/INFUSION,Other descriptive name: ,Strength: Sodium Chloride 9mg,Pharmaceutical form of the placebo: SOLUTION FOR INJECTION/INFUSION,Route of administration of the placebo: INTRAVENOUS INFUSION CONDITION: Fungal infection Therapeutic area: Diseases [C] ‐ Bacterial Infections and Mycoses [C01] PRIMARY OUTCOME: Main Objective:To explore whether treatment with prophylactic antimycotic medicine can reduce complications after radical cystectomy compared to placebo. Primary end point(s):Postoperative complications measured by Clavien Dindo III‐V classification score Secondary Objective: SECONDARY OUTCOME: Secondary end point(s):Days Alive and Out of Hospital measured within the 90th postoperative day Secondary end point(s):Length of stay for inde Xadmission Secondary end point(s):Microbiome resistance development in the urinary tract Secondary end point(s):Quality of Life measured by questionnaires (EORTC QLQ‐C30 and QLQ‐BLM30) at day 0 and day 90 Secondary end point(s):Re‐admission within 30 and 90 days Secondary end point(s):Reduction in percentage of patients who require placement of nasogastric tube postoperatively Secondary end point(s):Time to gastrointestinal function (first bowel movement) postoperatively Secondary end point(s):Urinary tract infections requiring treatment INCLUSION CRITERIA: Patients > 18 years,Willingness to participate in the study and the ability to understand and sign an informed consent in Danish,Indication for performing cystectomy,The urinary diversion is limited to the ileal conduit