IMPACT - Introduction of Mycotic Prophylaxis At Cystectomy Trial Perioperative mycotic prophylaxis to reduce postoperative complications following cystectomy – study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial

IMPACT - Introduction of Mycotic Prophylaxis At Cystectomy Trial Perioperative mycotic prophylaxis to reduce postoperative complications following cystectomy – study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article IMPACT - Introduction of Mycotic Prophylaxis At Cystectomy Trial Perioperative mycotic prophylaxis to reduce postoperative complications following cystectomy – study protocol for a national multi-center, double-blinded, placebo-controlled, randomized clinical trial Mie Skjøttgaard Ynddal, Hein Vincent Stroomberg, Maja Vejlgaard, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7590807/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Introduction and objectives Cystectomy with urinary diversion is one of the most complex surgeries in the urological specialty involving surgery on multiple organ systems. The postoperative risk of mortality and complications is considerable, and the first months after surgery are often the most critical. When creating the urinary diversion, the abdominal cavity is exposed to bacteria and fungus from the small intestine, and after the surgery, micro-leakage from the intestinal anastomosis may also contribute to a local infectious response. This contamination is suspected to increase the risk of bowel paralysis that, even with modern ERAS protocols, significantly impacts the postoperative recovery. Emerging data show that approximately 50% of the patients undergoing cystectomy have Candida albicans in samples from the terminal ileum. Current guidelines support the use of perioperative antibiotics, but there are currently no guidelines on antimycotic prophylaxis. We present a randomized clinical trial that tests whether incorporating antimycotics into the perioperative antimicrobial prophylactic regimen can reduce complications after cystectomy. Materials and methods This is a multi-center, double-blinded, randomized clinical trial including participants from all five centers in Denmark performing cystectomy. The study includes adult patients planned for cystectomy with an ileal conduit with no contraindications to fluconazole and no active treatment for mycotic infections. The 420 participants are randomized 1:1 to receive a single-dose of perioperative fluconazole or placebo. Primary outcome is major postoperative complications, defined as Clavien-Dindo classification III-V, within 90 days following cystectomy. Secondary outcomes are days alive and out of hospital, gastrointestinal function, nasogastric tube placement, length of stay, readmissions, quality of life and microbiological test results. We aim to reduce the absolute rate of Clavien-Dindo III-V complications from 30% to 18%. The study is a superiority study and analysis will be performed as intention-to-treat. Discussion Patients undergoing cystectomy face a high risk of surgical complications, many of which can be attributed to infections. There is a growing concern about the consequences of fungal infections after abdominal surgery. This trial aims to explore whether prophylactic antifungal treatment at the time of cystectomy can prevent postoperative complications. Mycotic prophylaxis Fungal prophylaxis Fluconazole Radical Cystectomy Ileal conduit Postoperative complications Randomized trial Multicenter Full Text Supplementary Files SPIRITchecklist.pdf Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Minor revision 11 Mar, 2026 Reviewers agreed at journal 02 Dec, 2025 Reviewers invited by journal 13 Oct, 2025 Editor assigned by journal 06 Oct, 2025 First submitted to journal 29 Sep, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7590807","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":529061315,"identity":"5f575cf5-184b-4ea5-a073-fc491fd57b64","order_by":0,"name":"Mie Skjøttgaard 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