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Introduction of Mycotic Prophylaxis At Cystectomy Trial.

ConditionCystectomy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fluconazole

    Drug

    400 mg inravenous Fluconazole, single dose 200 ml

  • Isotonic saline solution

    Drug

    Intravenous saline solution, single dose 200 ml

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: FluconazoleExperimental treatment 1 intervention
Group B: Isotonic saline solutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative complications

Measured by Clavien Dindo III-V classification score. The Clavien Dindo Classification is used to rank the severity of a surgical complication. It consists of seven grades (I, II, IIIa, IIIb, IVa, IVb, V) with I being any deviation from the normal postoperative course and V being death of a patient.

Time frame
90 days from surgery

Secondary outcomes

1

Days Alive and Out of Hospital (DAOH)

Number of days alive and out of hospital within 90 days from surgery

Time frame
90 days from surgery
2

Time to gastrointestinal function

First bowel movement

Time frame
Postoperatively within 90 days
3

Nasogastric tube placement

Number of nasogastric tube placements

Time frame
Postoperatively within 90 days
4

Length of stay (LOS)

Duration (days) of primary hospitalization.

Time frame
90 days from surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov
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