Introduction of Mycotic Prophylaxis At Cystectomy Trial.

Phase 4

Recruiting

• Conditions: Cystectomy
• Interventions: Drug: Fluconazole; Drug: Isotonic saline solution

• Registration Number: NCT06770530
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study First Submitted: 2024-05-31
• Status Verified: 2024-06
• Study Start: 2024-06-24
• Study First Submitted QC: 2025-01-07
• Last Update Submitted: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2027-06
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 484

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluconazole	Fluconazole	Intravenous Fluconazole 400 mg single dose in 200 ml saline solution
Isotonic saline solution	Isotonic saline solution	Intravenous saline solution single dose 200 ml

Primary Outcome Measures

Name	Time	Method
Postoperative complications	90 days from surgery	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.

Secondary Outcome Measures

Name	Time	Method
Days Alive and Out of Hospital (DAOH)	90 days from surgery	Number of days alive and out of hospital within 90 days from surgery
Time to gastrointestinal function	Postoperatively within 90 days	First bowel movement
Nasogastric tube placement	Postoperatively within 90 days	Number of nasogastric tube placements
Length of stay (LOS)	90 days from surgery	Duration (days) of primary hospitalization.
Readmission rate	90 days after surgery	Number of readmissions
Quality of life (QoL): EORTC QLQ-C30	Before operation and 90 days after surgery	Questionnaire from EORTC: European Organization for Research and Treatment of Cancer. All of the scales and single-item measures range in score from 0 to 100. The questionnaires consists of a global health status (high score represents high quality of life), a functional scale (a high score represents a high/healthy level of functioning) and a symptom scale (a high score represents a high level of symptomatology/problems).
Quality of Life(QOL): EORTC QLQ-BLM30	Before operation and 90 days after	Questionnaire from EORTC: European Organization for Research and Treatment of Cancer. All of the scales and single-item measures range in score from 0 to 100. The questionnaires consists of a global health status (high score represents high quality of life), a functional scale (a high score represents a high/healthy level of functioning) and a symptom scale (a high score represents a high level of symptomatology/problems).

Trial Locations

Locations (1)

Department of Urology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark