Using antifungal medication to prevent complications after bladder removal surgery.
Official title: 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
Run by Copenhagen University Hospital, Rigshospitalet · NCT06770530 · Data updated 2026-11-12
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 |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | June 24, 2024 |
| Main results expected | June 2027 |
| Study ends | September 2027 |
| Registry record updated | August 12, 2026 |
| Trial ID | NCT06770530 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older who are scheduled for cystectomy with an ileal conduit urinary diversion.
✕Probably not a fit
Patients with allergies to Fluconazole or those currently being treated for mycotic infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While antifungal prophylaxis in surgical settings is emerging, this specific approach in cystectomy is novel and has not been extensively tested in prior studies.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ovarian Reserve After Cystectomy for Endometriotic vs. Non-Endometriotic Cysts
This study tests how laparoscopic removal of ovarian cysts affects ovarian reserve in women with endometriotic cysts compared to benign/non-endometriotic cysts.
-
Spraying low‑concentration lidocaine under the diaphragm to reduce shoulder pain after single‑port gynecologic laparoscopy
This will try spraying 0.08% lidocaine under the diaphragm at the start of single‑port laparoscopic surgery to see if it reduces immediate postoperative shoulder pain and improves mood for women having benign gynecologic operations.
-
Home IV fluid infusions after radical cystectomy
This trial will test whether giving home IV fluids after radical cystectomy for bladder cancer reduces 90-day hospital readmissions.
-
Robot-assisted radical cystectomy: effects on blood loss, pain, and transfusions
This trial will test whether robot-assisted bladder removal (radical cystectomy), with or without bladder reconstruction, leads to less blood loss, less postoperative pain, and fewer transfusions for people scheduled for radical cystectomy.
-
How genetic differences affect nalbuphine pain relief after abdominal or pelvic surgery
We will test whether genetic differences change how well nalbuphine relieves pain after abdominal or pelvic surgery in adults.
-
Testing targeted antibiotics to prevent infections after bladder surgery
This study is testing if using personalized antibiotics based on urine bacteria can help prevent infections after bladder surgery better than standard antibiotics.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.