Introduction of Mycotic Prophylaxis At Cystectomy Trial.
IMPACT - the Introduction of Mycotic Prophylaxis At Cystectomy Trial. Perioperative Mycotic Prophylaxis to Reduce Postoperative Complications Following Cystectomy - a Double-blinded, Placebo-controlled, Randomized Trial
Rigshospitalet, Denmark
484 participants
Jun 24, 2024
INTERVENTIONAL
Conditions
Summary
This study aims to introduce a perioperative antifungal prophylaxis for patients undergoing cystectomy: surgically removal of the urinary bladder with construction of a urinary diversion. We wish to investigate the effect of antifungal prophylaxis on complications after the operation.
Eligibility
Inclusion Criteria4
- Patients 18 years and older
- Willingness to participate in the study and the ability to understand and sign an informed consent
- Indication for performing cystectomy
- The urinary diversion is limited to the ileal conduit
Exclusion Criteria2
- Patients with contraindications to Fluconazole. This includes allergies and treatment with non-pausable medication that in combination is contraindicated
- Patients in active treatment for mycotic infections
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Interventions
400 mg inravenous Fluconazole, single dose 200 ml
Intravenous saline solution, single dose 200 ml
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06770530