Cystostomy InfectionNCT03290742
Infection Among Patients Undergoing Radical Cystectomy.
An observational study of Cystostomy Infection, run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial summary
Investigators plan to perform a review of medical records a single urology department to identify patients with febrile perioperative infection who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystostomy Infection
- How many people
- 133 participants
- Where
- 1 sitePoland
- Study dates
- 4 Aug 2017to 30 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.
Who may be able to join
- Patients who underwent radical cystectomy and urinary diversion for bladder cancer.
Who cannot join
- documented infection at the time of radical cystectomy
- concurrent organ resection such as nephrectomy, nephroureterectomy
- partial cystectomy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Urology and Urological Oncology
Szczecin, West Pomeranian Voivodeship, 70-111
About this study
Official title: Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy
Investigators plan to perform a review of medical records a single urology department to identify patients with febrile perioperative infection who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.
Investigators plan assess a potential variables to find correlation with infections after surgery.
Characteristics, including age, sex, length of hospital stay, body mass index (BMI), diabetes, hypertension, estimated glomerular filtration rate (eGFR), preoperative hydronephrosis, smoking status, neoadjuvant chemotherapy, pathological stage, lymph node involvement, types of urinary diversion, operative method (open/laparoscopic), operative time and receipt of a perioperative blood transfusion (PBT) will be asses as potential risk factor for perioperative infection.
- Conditions
- Cystostomy Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients without documented infection. | Patients without infection during 30 day follow-up after radical cystectomy. | |
| Patients with documented infection. | Patients with documented any kind of infection (urinary tract infection, blood infection/septic shock, surgical site infection) during 30 day follow-up after radical cystectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with perioperative infection after radical cystectomy.
A review of medical records in a single urology department will be performed to identified all participants with perioperative infection after radical cystectomy.
Measured: 30 days
Secondary outcomes (16)
Association between perioperative infection after radical cystectomy and patients' age.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and sex.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and length of hospital stay.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and body mass index.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and diabetes.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and hypertension.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and smoking status.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and pathological stage.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and lymph node involvement.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and types of urinary diversion.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and operative time.
Logistic regression analysis.
Measured: 30 days
Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.
Logistic regression analysis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start4 Aug 2017
- Primary completion20 Aug 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystostomy InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krystian Kaczmarek, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290742
- Sponsor's protocol ID
- INF1
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy
- ClinicalTrials.gov ID
- NCT03290742
- Acronym / sponsor ID
- INF1
- Conditions
- Cystostomy Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 4 Aug 2017 (actual)
- Primary completion
- 20 Aug 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 25 Sep 2017 (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.
Investigators plan to perform a review of medical records a single urology department to identify patients with febrile perioperative infection who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.
Investigators plan assess a potential variables to find correlation with infections after surgery.
Characteristics, including age, sex, length of hospital stay, body mass index (BMI), diabetes, hypertension, estimated glomerular filtration rate (eGFR), preoperative hydronephrosis, smoking status, neoadjuvant chemotherapy, pathological stage, lymph node involvement, types of urinary diversion, operative method (open/laparoscopic), operative time and receipt of a perioperative blood transfusion (PBT) will be asses as potential risk factor for perioperative infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without documented infection. | – | –Patients without infection during 30 day follow-up after radical cystectomy. |
| Patients with documented infection. | – | –Patients with documented any kind of infection (urinary tract infection, blood infection/septic shock, surgical site infection) during 30 day follow-up after radical cystectomy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.
Key inclusion criteria (1 listed)
- Patients who underwent radical cystectomy and urinary diversion for bladder cancer.
Key exclusion criteria (3 listed)
- documented infection at the time of radical cystectomy
- concurrent organ resection such as nephrectomy, nephroureterectomy
- partial cystectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with perioperative infection after radical cystectomy.
Time frame: 30 days
A review of medical records in a single urology department will be performed to identified all participants with perioperative infection after radical cystectomy.
16 secondary outcomes
Association between perioperative infection after radical cystectomy and patients' age.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and sex.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and length of hospital stay.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and body mass index.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and diabetes.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and hypertension.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate
Time frame: 30 days
Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and smoking status.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and pathological stage.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and lymph node involvement.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and types of urinary diversion.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).
Time frame: 30 days
Association between perioperative infection after radical cystectomy and operative time.
Time frame: 30 days
Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystostomy Infection, run by Pomeranian Medical University Szczecin at 1 site in Poland.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 25 Sep 2017. 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 Poland. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with perioperative infection after radical cystectomy. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017.