CystectomyPhase 4IMPACTNCT06770530
Introduction of Mycotic Prophylaxis At Cystectomy Trial.
A Phase 4 study testing Fluconazole and Isotonic saline solution in people with Cystectomy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystectomy
- What is being tested?
- Fluconazole and Isotonic saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Jun 2024to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Department of Urology, Rigshospitalet
Copenhagen, 2100
Adreas Røder, MD, PhD, Professor, +4535458789, andreas.roeder@regionh.dk
About this study
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
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.
Read the 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.
- Conditions
- Cystectomy
- Being tested
- Fluconazole, Isotonic saline solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluconazoleDrug
400 mg inravenous Fluconazole, single dose 200 ml
Isotonic saline solutionDrug
Intravenous saline solution, single dose 200 ml
| Study group | Role | What they receive |
|---|---|---|
| Fluconazole | Experimental | Intravenous Fluconazole 400 mg single dose in 200 ml saline solution Receives: Drug: Fluconazole |
| Isotonic saline solution | Placebo comparator | Intravenous saline solution single dose 200 ml Receives: Drug: Isotonic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days from surgery
Secondary outcomes (7)
Days Alive and Out of Hospital (DAOH)
Number of days alive and out of hospital within 90 days from surgery
Measured: 90 days from surgery
Time to gastrointestinal function
First bowel movement
Measured: Postoperatively within 90 days
Nasogastric tube placement
Number of nasogastric tube placements
Measured: Postoperatively within 90 days
Length of stay (LOS)
Duration (days) of primary hospitalization.
Measured: 90 days from surgery
Readmission rate
Number of readmissions
Measured: 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).
Measured: 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).
Measured: Before operation and 90 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start24 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CystectomyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mie Ynddal, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Andreas Røder, MD, PhD, Professor, Principal investigator, Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, DenmarkUlla N Joensen, MD, PhD, Principal investigator, Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770530
- Sponsor's protocol ID
- 2023-506226-36-00
- Other IDs
- 2023
- Acronym
- IMPACT
- Status last verified
- Sep 2025
- First submitted
- 31 May 2024
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34337519Andrijasevic 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.
PubMed 35704932Lightner 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.
PubMed 31441676Villmones 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.
PubMed 32835795Prunty 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.
PubMed 36383758Mitropoulos 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.
PubMed 22074761Maibom 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.
PubMed 34657367Mitropoulos 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.
PubMed 28753862Dindo 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.
PubMed 15273542Osoba 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.
PubMed 9440735Ynddal 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.
PubMed 42380957
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06770530
- Acronym / sponsor ID
- IMPACT / 2023-506226-36-00
- Conditions
- Cystectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluconazole | Experimental | Drug: FluconazoleIntravenous Fluconazole 400 mg single dose in 200 ml saline solution |
| Isotonic saline solution | Placebo comparator | Drug: Isotonic saline solutionIntravenous saline solution single dose 200 ml |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluconazole400 mg inravenous Fluconazole, single dose 200 ml | Drug | Fluconazole |
| Isotonic saline solutionIntravenous saline solution, single dose 200 ml | Drug | Isotonic saline solution |
Primary outcome
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.
7 secondary outcomes
Days Alive and Out of Hospital (DAOH)
Time frame: 90 days from surgery
Time to gastrointestinal function
Time frame: Postoperatively within 90 days
Nasogastric tube placement
Time frame: Postoperatively within 90 days
Length of stay (LOS)
Time frame: 90 days from surgery
Readmission rate
Time frame: 90 days after surgery
Quality of life (QoL): EORTC QLQ-C30
Time frame: Before operation and 90 days after surgery
Quality of Life(QOL): EORTC QLQ-BLM30
Time frame: Before operation and 90 days after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 34337519Maibom 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.
- Background: PubMed 35704932Andrijasevic 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.
- Background: PubMed 31441676Lightner 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.
- Background: PubMed 32835795Villmones 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.
- Background: PubMed 36383758Prunty 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.
- Background: PubMed 22074761Mitropoulos 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.
- Background: PubMed 34657367Maibom 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.
- Background: PubMed 28753862Mitropoulos 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.
- Background: PubMed 15273542Dindo 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.
- Background: PubMed 9440735Osoba 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.
- Derived from this study: PubMed 42380957Ynddal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Røder, MD, PhD, Professor principal investigator
Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
Ulla N Joensen, MD, PhD principal investigator
Urological Research Unit, Department of Urology, Rigshospitalet Blegdamsvej 9, 2100 Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluconazole and Isotonic saline solution in people with Cystectomy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mie Ynddal, MD (+4535456152, mie.skjoettgaard.ynddal@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 90 days from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770530, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.