Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Using antifungal medication to prevent complications after bladder removal surgery.

Official title: 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

Run by Copenhagen University Hospital, Rigshospitalet · NCT06770530 · Data updated 2026-11-12

This study tests whether giving antifungal medicine to patients after bladder removal surgery can help prevent infections and other complications.

Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment420 (estimated)
SponsorCopenhagen University Hospital, Rigshospitalet
Academic / other
Locations1 site (Copenhagen)
StatusRecruiting
StartedJune 24, 2024
Main results expectedJune 2027
Study endsSeptember 2027
Registry record updatedAugust 12, 2026
Trial IDNCT06770530 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18 and older who are scheduled for cystectomy with an ileal conduit urinary diversion.

Probably not a fit

Patients with allergies to Fluconazole or those currently being treated for mycotic infections may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of antifungal prophylaxis with Fluconazole for patients undergoing cystectomy, a complex surgical procedure involving the removal of the urinary bladder and construction of a urinary diversion. The aim is to assess the impact of this prophylaxis on postoperative complications, particularly those related to infections and ileal paralysis. By addressing the risk of fungal infections, which are prevalent in patients undergoing such surgeries, the study seeks to improve patient outcomes and reduce the length of hospital stays.

Why it matters

Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for patients undergoing cystectomy.

How similar studies have gone: While antifungal prophylaxis in surgical settings is emerging, this specific approach in cystectomy is novel and has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Department of Urology, Rigshospitalet
    Copenhagen, Denmark
    Recruiting

Study contacts

  • Principal investigator: Andreas Røder, MD, PhD, Professor — Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
  • Study coordinator: Mie Ynddal, MD
  • Email: mie.skjoettgaard.ynddal@regionh.dk
  • Phone: +4535456152

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.