Department of Urology and Urological Oncology
Szczecin, West Pomeranian Voivodeship, 70-111, Poland
Completed
NCT Number: NCT03290742
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.
Completed
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Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients who underwent radical cystectomy and urinary diversion for bladder cancer.
Exclusion criteria
- documented infection at the time of radical cystectomy
- concurrent organ resection such as nephrectomy, nephroureterectomy
- partial cystectomy
Treatment and study plan
Primary outcomes
-
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.
Secondary outcomes
-
Association between perioperative infection after radical cystectomy and patients' age.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and sex.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and length of hospital stay.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and body mass index.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and diabetes.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and hypertension.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and smoking status.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and pathological stage.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and lymph node involvement.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and types of urinary diversion.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and operative time.
Time frame: 30 days
Logistic regression analysis.
-
Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.
Time frame: 30 days
Logistic regression analysis.
Sponsors and collaborators
Lead sponsor
Pomeranian Medical University Szczecin
Other
Registry information
Official study title
Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Sep 25, 2017
- Registry last updated
- Sep 25, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.