RecruitingPhase 4NCT06770530

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


Sponsor

Rigshospitalet, Denmark

Enrollment

484 participants

Start Date

Jun 24, 2024

Study Type

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

Min Age: 18 Years

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

DRUGFluconazole

400 mg inravenous Fluconazole, single dose 200 ml

DRUGIsotonic saline solution

Intravenous saline solution, single dose 200 ml


Locations(1)

Department of Urology, Rigshospitalet

Copenhagen, Denmark

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NCT06770530


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