Using antifungal medication to prevent complications after bladder removal surgery.
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 tests whether giving antifungal medicine to patients after bladder removal surgery can help prevent infections and other complications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 484 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06770530 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of antifungal prophylaxis with Fluconazole for patients undergoing cystectomy, a complex surgical procedure involving the removal of the urinary bladder and construction of a urinary diversion. The aim is to assess the impact of this prophylaxis on postoperative complications, particularly those related to infections and ileal paralysis. By addressing the risk of fungal infections, which are prevalent in patients undergoing such surgeries, the study seeks to improve patient outcomes and reduce the length of hospital stays.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for cystectomy with an ileal conduit urinary diversion.
Not a fit: Patients with allergies to Fluconazole or those currently being treated for mycotic infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications and improve recovery for patients undergoing cystectomy.
How similar studies have performed: While antifungal prophylaxis in surgical settings is emerging, this specific approach in cystectomy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Department of Urology, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Andreas Røder, MD, PhD, Professor — Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
- Study coordinator: Mie Ynddal, MD
- Email: mie.skjoettgaard.ynddal@regionh.dk
- Phone: +4535456152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.