Infection Among Patients Undergoing Radical Cystectomy.

September 20, 2017 updated by: Krystian Kaczmarek, Pomeranian Medical University Szczecin

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

133

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • West Pomeranian
      • Szczecin, West Pomeranian, Poland, 70-111
        • Department of Urology and Urological Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent radical cystectomy and urinary diversion for bladder cancer from January 2014 to July 2017.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between perioperative infection after radical cystectomy and patients' age.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and sex.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and length of hospital stay.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and body mass index.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and diabetes.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and hypertension.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and preoperative hydronephrosis.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and smoking status.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and pathological stage.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and lymph node involvement.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and types of urinary diversion.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic).
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and operative time.
Time Frame: 30 days
Logistic regression analysis.
30 days
Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion.
Time Frame: 30 days
Logistic regression analysis.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 4, 2017

Primary Completion (ACTUAL)

August 20, 2017

Study Completion (ACTUAL)

August 30, 2017

Study Registration Dates

First Submitted

September 14, 2017

First Submitted That Met QC Criteria

September 20, 2017

First Posted (ACTUAL)

September 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 20, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INF1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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