Clinical trial NCT06770530: Introduction of Mycotic Prophylaxis At Cystectomy Trial.
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Cystectomy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Cystectomy with construction of a urinary diversion, is a major cancer surgery and one of the most complex surgeries in the urological specialty. After cystectomy, the most commonly performed urinary diversion is an ileal conduit, where a section of the terminal ileum is shunted out and connected to the upper urinary tract and a stoma is created. During this procedure, the abdominal cavity is exposed to bacteria and fungus from the ileum. Besides the perioperative contamination, micro-leakage in relation to the anastomosis is suspected to contribute to a local infectious response that may result in postoperative complications as ileal paralysis. Paralytic ileus is a serious complication that affects many patients after cystectomy, resulting in a prolonged length of stay, low quality of life postoperatively, and increased risk of complications such as aspiration, pneumonia, wound rupture, deep venous thrombosis, undernourishment and infections.

Current guidelines support the use of perioperative antibiotics targeting gram-negative and gram-positive bacteria, typically administered as broad-spectrum medicine such as piperacillin/tazobactam or cephalosporins. Regarding fungal infections, emerging data show that 48% of the patients undergoing RC have candida albicans in samples from the terminal ileum. Also, it is well known that fungal infections are highly prevalent in patients undergoing gastrointestinal surgery where it is associated with a high risk of mortality.

Small retrospective studies suggest that the addition of antifungal medicine to perioperative antibiotics can reduce the risk of bowel- and infectious complications after abdominal surgery.

The compelling theoretical and clinical rationale for addition of antifungal prophylaxis to standard-of-care antibiotic prophylaxis for patients undergoing radical cystectomy provides the basis for initiation of a randomized clinical trial representing the highest level of evidence.

Eligibility 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

Primary outcomes:
measure: Postoperative complications
timeFrame: 90 days from surgery
Secondary outcomes:
measure: Days Alive and Out of Hospital (DAOH)
timeFrame: 90 days from surgery
measure: Time to gastrointestinal function
timeFrame: Postoperatively within 90 days
measure: Nasogastric tube placement
timeFrame: Postoperatively within 90 days
measure: Length of stay (LOS)
timeFrame: 90 days from surgery
measure: Readmission rate
timeFrame: 90 days after surgery
measure: Quality of life (QoL): EORTC QLQ-C30
timeFrame: Before operation and 90 days after surgery
measure: Quality of Life(QOL): EORTC QLQ-BLM30
timeFrame: Before operation and 90 days after
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Urology, Rigshospitalet
Study officials:
affiliation: Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
name: Andreas Røder, MD, PhD, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
name: Ulla N Joensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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