Infection Among Patients Undergoing Radical Cystectomy.

Overview

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.

Full Title of Study: “Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 20, 2017

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pomeranian Medical University Szczecin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Krystian Kaczmarek, Principal Investigator – Pomeranian Medical University Szczecin

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