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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
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506226-36-00
Enrollment
420
Registered
2024-02-16
Start date
2024-06-23
Completion date
Unknown
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal infection

Brief summary

Postoperative complications measured by Clavien Dindo III-V classification score

Detailed description

Days Alive and Out of Hospital measured within the 90th postoperative day, Time to gastrointestinal function (first bowel movement) postoperatively, Reduction in percentage of patients who require placement of nasogastric tube postoperatively, Quality of Life measured by questionnaires (EORTC QLQ-C30 and QLQ-BLM30) at day 0 and day 90, Length of stay for index admission, Re-admission within 30 and 90 days, Microbiome resistance development in the urinary tract, Urinary tract infections requiring treatment

Interventions

DRUGFluconazole Kabi 2mg/ml solution for infusion

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Postoperative complications measured by Clavien Dindo III-V classification score

Secondary

MeasureTime frame
Days Alive and Out of Hospital measured within the 90th postoperative day, Time to gastrointestinal function (first bowel movement) postoperatively, Reduction in percentage of patients who require placement of nasogastric tube postoperatively, Quality of Life measured by questionnaires (EORTC QLQ-C30 and QLQ-BLM30) at day 0 and day 90, Length of stay for index admission, Re-admission within 30 and 90 days, Microbiome resistance development in the urinary tract, Urinary tract infections requiring treatment

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026