Introduction of Mycotic Prophylaxis At Cystectomy Trial.
NCT06770530 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 484
Last updated 2025-01-13
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.
Conditions
- Cystectomy
Interventions
- DRUG
-
Fluconazole
400 mg inravenous Fluconazole, single dose 200 ml
- DRUG
-
Isotonic saline solution
Intravenous saline solution, single dose 200 ml
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Principal Investigators
-
Andreas Røder, MD, PhD, Professor · Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
-
Ulla N Joensen, MD, PhD · Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-24
- Primary Completion
- 2027-06-30
- Completion
- 2027-09-30
Countries
- Denmark
Study Locations
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