Introduction of Mycotic Prophylaxis At Cystectomy Trial. (IMPACT)

Rigshospitalet

Status and phase: Enrolling; Phase 4

Conditions: Cystectomy

Treatments: Drug: Isotonic saline solution; Drug: Fluconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT06770530

2023-506226-36-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 484 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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484 participants in 2 patient groups, including a placebo group

Fluconazole

Experimental group

Description:

Intravenous Fluconazole 400 mg single dose in 200 ml saline solution

Treatment:

Drug: Fluconazole

Isotonic saline solution

Placebo Comparator group

Description:

Intravenous saline solution single dose 200 ml

Treatment:

Drug: Isotonic saline solution