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One dose before surgery: could an antifungal cut serious Post-Op risks?

NCT ID NCT06770530

Disease control Sponsor: Rigshospitalet, Denmark Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial tests whether giving a single dose of the antifungal drug fluconazole just before bladder removal surgery (cystectomy) can lower the risk of serious postoperative complications. The study includes 420 adults scheduled for cystectomy with an ileal conduit, who will receive either fluconazole or a placebo (saline) intravenously. Researchers will track complications like infections and bowel issues, as well as how long patients stay in the hospital. The goal is to see if this simple preventive step can improve recovery after a major operation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Fluconazole (an antifungal drug) given as a single intravenous dose before surgery, compared with a placebo (saline solution).
What this could lead to
If effective, a single dose of fluconazole could become a standard preventive measure to reduce serious complications after bladder removal surgery, improving recovery and shortening hospital stays.
What could go wrong
This is a single trial, and the benefit is not guaranteed. Fluconazole may not reduce complications, and there are risks of allergic reactions or interactions with other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cystectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Urology, Rigshospitalet

    RECRUITING

    Copenhagen, 2100, Denmark

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