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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
Department of Urology, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Mie Ynddal, MD
mie.skjoettgaard.ynddal@regionh.dk
+4535456152
Time Frame
Start Date: 2024-06-24
Estimated Completion Date: 2027-09
Participants
Target number of participants: 484
Treatments
Experimental: Fluconazole
Intravenous Fluconazole 400 mg single dose in 200 ml saline solution
Placebo_comparator: Isotonic saline solution
Intravenous saline solution single dose 200 ml
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark