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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluconazole | Experimental | Intravenous Fluconazole 400 mg single dose in 200 ml saline solution |
|
| Isotonic saline solution | Placebo Comparator | Intravenous saline solution single dose 200 ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | 400 mg inravenous Fluconazole, single dose 200 ml |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 90 days from surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Days Alive and Out of Hospital (DAOH) | Number of days alive and out of hospital within 90 days from surgery | 90 days from surgery |
| Time to gastrointestinal function | First bowel movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mie Ynddal, MD | Contact | +4535456152 | mie.skjoettgaard.ynddal@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34337519 | Background | Maibom SL, Roder MA, Poulsen AM, Thind PO, Salling ML, Salling LN, Kehlet H, Brasso K, Joensen UN. Morbidity and Days Alive and Out of Hospital Within 90 Days Following Radical Cystectomy for Bladder Cancer. Eur Urol Open Sci. 2021 Apr 19;28:1-8. doi: 10.1016/j.euros.2021.03.010. eCollection 2021 Jun. | |
| 35704932 | Background |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Isotonic saline solution |
| Drug |
Intravenous saline solution, single dose 200 ml |
|
| Postoperatively within 90 days |
| Nasogastric tube placement | Number of nasogastric tube placements | Postoperatively within 90 days |
| Length of stay (LOS) | Duration (days) of primary hospitalization. | 90 days from surgery |
| Readmission rate | Number of readmissions | 90 days after surgery |
| Quality of life (QoL): EORTC QLQ-C30 | 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 | 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 |
| Principal Investigator |
| Andrijasevic N, Ovcaricek S, Butic I, Navratil M, Mili B. Comparison of the effectiveness of two combinations of antibiotic used for perioperative prophylactic therapy during radical cystectomy: A retrospective cohort study. Can Urol Assoc J. 2022 Nov;16(11):E539-E544. doi: 10.5489/cuaj.7859. |
| 31441676 | Background | Lightner DJ, Wymer K, Sanchez J, Kavoussi L. Best Practice Statement on Urologic Procedures and Antimicrobial Prophylaxis. J Urol. 2020 Feb;203(2):351-356. doi: 10.1097/JU.0000000000000509. Epub 2019 Aug 23. |
| 32835795 | Background | Villmones HC, Halland A, Stenstad T, Ulvestad E, Weedon-Fekjaer H, Kommedal O. The cultivable microbiota of the human distal ileum. Clin Microbiol Infect. 2021 Jun;27(6):912.e7-912.e13. doi: 10.1016/j.cmi.2020.08.021. Epub 2020 Aug 21. |
| 36383758 | Background | Prunty M, Rhodes S, Rivero MJ, Callegari M, Jesse E, Arenas-Gallo C, Brant A, Calaway A, Scherr D, Shoag JE. National Adherence to Guidelines for Antimicrobial Prophylaxis for Patients Undergoing Radical Cystectomy. J Urol. 2023 Feb;209(2):329-336. doi: 10.1097/JU.0000000000003069. Epub 2022 Nov 16. |
| 22074761 | Background | Mitropoulos D, Artibani W, Graefen M, Remzi M, Roupret M, Truss M; European Association of Urology Guidelines Panel. Reporting and grading of complications after urologic surgical procedures: an ad hoc EAU guidelines panel assessment and recommendations. Eur Urol. 2012 Feb;61(2):341-9. doi: 10.1016/j.eururo.2011.10.033. Epub 2011 Oct 29. |
| 34657367 | Background | Maibom SL, Roder MA, Aasvang EK, Rohrsted M, Thind PO, Bagi P, Kistorp T, Poulsen AM, Salling LN, Kehlet H, Brasso K, Joensen UN. Open vs robot-assisted radical cystectomy (BORARC): a double-blinded, randomised feasibility study. BJU Int. 2022 Jul;130(1):102-113. doi: 10.1111/bju.15619. Epub 2021 Nov 9. |
| 28753862 | Background | Mitropoulos D, Artibani W, Biyani CS, Bjerggaard Jensen J, Roupret M, Truss M. Validation of the Clavien-Dindo Grading System in Urology by the European Association of Urology Guidelines Ad Hoc Panel. Eur Urol Focus. 2018 Jul;4(4):608-613. doi: 10.1016/j.euf.2017.02.014. Epub 2017 Mar 7. |
| 15273542 | Background | Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. |
| 9440735 | Background | Osoba D, Rodrigues G, Myles J, Zee B, Pater J. Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol. 1998 Jan;16(1):139-44. doi: 10.1200/JCO.1998.16.1.139. |
| 42380957 | Derived | Ynddal MS, Stroomberg HV, Vejlgaard M, Jensen JB, Moser C, Joensen UN, Roder A. IMPACT-Introduction of Mycotic Prophylaxis At Cystectomy Trial: perioperative mycotic prophylaxis with fluconazole to reduce postoperative complications following cystectomy-study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial. Trials. 2026 Jun 30. doi: 10.1186/s13063-026-09862-6. Online ahead of print. |