Clinical trial NCT03290742: Infection Among Patients Undergoing Radical Cystectomy.
Official title: Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystostomy Infection
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 133
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with perioperative infection after radical cystectomy.
timeFrame: 30 days
Secondary outcomes:
measure: Association between perioperative infection after radical cystectomy and patients' age.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and sex.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and length of hospital stay.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and body mass index.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and diabetes.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and hypertension.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and smoking status.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and pathological stage.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and lymph node involvement.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and types of urinary diversion.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and operative time.
timeFrame: 30 days
measure: Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.
timeFrame: 30 days
Other outcomes:
Locations:
city: Szczecin
country: Poland
facility: Department of Urology and Urological Oncology
state: West Pomeranian
Study officials:
References: