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Infection Among Patients Undergoing Radical Cystectomy.

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ClinicalTrials.gov Identifier: NCT03290742
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
Krystian Kaczmarek, Pomeranian Medical University Szczecin

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.


Condition or disease
Cystostomy Infection

Study Type : Observational
Actual Enrollment : 133 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy
Actual Study Start Date : August 4, 2017
Actual Primary Completion Date : August 20, 2017
Actual Study Completion Date : August 30, 2017

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Association between perioperative infection after radical cystectomy and patients' age. [ Time Frame: 30 days ]
    Logistic regression analysis.

  2. Association between perioperative infection after radical cystectomy and sex. [ Time Frame: 30 days ]
    Logistic regression analysis.

  3. Association between perioperative infection after radical cystectomy and length of hospital stay. [ Time Frame: 30 days ]
    Logistic regression analysis.

  4. Association between perioperative infection after radical cystectomy and body mass index. [ Time Frame: 30 days ]
    Logistic regression analysis.

  5. Association between perioperative infection after radical cystectomy and diabetes. [ Time Frame: 30 days ]
    Logistic regression analysis.

  6. Association between perioperative infection after radical cystectomy and hypertension. [ Time Frame: 30 days ]
    Logistic regression analysis.

  7. Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate [ Time Frame: 30 days ]
    Logistic regression analysis.

  8. Association between perioperative infection after radical cystectomy and preoperative hydronephrosis. [ Time Frame: 30 days ]
    Logistic regression analysis.

  9. Association between perioperative infection after radical cystectomy and smoking status. [ Time Frame: 30 days ]
    Logistic regression analysis.

  10. Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy. [ Time Frame: 30 days ]
    Logistic regression analysis.

  11. Association between perioperative infection after radical cystectomy and pathological stage. [ Time Frame: 30 days ]
    Logistic regression analysis.

  12. Association between perioperative infection after radical cystectomy and lymph node involvement. [ Time Frame: 30 days ]
    Logistic regression analysis.

  13. Association between perioperative infection after radical cystectomy and types of urinary diversion. [ Time Frame: 30 days ]
    Logistic regression analysis.

  14. Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic). [ Time Frame: 30 days ]
    Logistic regression analysis.

  15. Association between perioperative infection after radical cystectomy and operative time. [ Time Frame: 30 days ]
    Logistic regression analysis.

  16. Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion. [ Time Frame: 30 days ]
    Logistic regression analysis.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290742


Locations
Poland
Department of Urology and Urological Oncology
Szczecin, West Pomeranian, Poland, 70-111
Sponsors and Collaborators
Pomeranian Medical University Szczecin

Responsible Party: Krystian Kaczmarek, Principal Investigator, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT03290742     History of Changes
Other Study ID Numbers: INF1
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases