Introduction of Mycotic Prophylaxis At Cystectomy Trial. (IMPACT)

January 7, 2025 updated by: Mie Ynddal, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

484

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Department of Urology, Rigshospitalet
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluconazole
Intravenous Fluconazole 400 mg single dose in 200 ml saline solution
Drug: Fluconazole
400 mg inravenous Fluconazole, single dose 200 ml
Placebo Comparator: Isotonic saline solution
Intravenous saline solution single dose 200 ml
Drug: Isotonic saline solution
Intravenous saline solution, single dose 200 ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: 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.
90 days from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Days Alive and Out of Hospital (DAOH)
Time Frame: 90 days from surgery
Number of days alive and out of hospital within 90 days from surgery
90 days from surgery
Readmission rate
Time Frame: 90 days after surgery
Number of readmissions
90 days after surgery
Time to gastrointestinal function
Time Frame: Postoperatively within 90 days
First bowel movement
Postoperatively within 90 days
Nasogastric tube placement
Time Frame: Postoperatively within 90 days
Number of nasogastric tube placements
Postoperatively within 90 days
Length of stay (LOS)
Time Frame: 90 days from surgery
Duration (days) of primary hospitalization.
90 days from surgery
Quality of life (QoL): EORTC QLQ-C30
Time Frame: 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).
Before operation and 90 days after surgery
Quality of Life(QOL): EORTC QLQ-BLM30
Time Frame: 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).
Before operation and 90 days after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Andreas Røder, MD, PhD, Professor, Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
  • Principal Investigator: Ulla N Joensen, MD, PhD, Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-506226-36-00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystectomy

Clinical Trials on Fluconazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe