Infection Among Patients Undergoing Radical Cystectomy.

NCT ID: NCT03290742

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-04

Study Completion Date

2017-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cystostomy Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients without documented infection.

Patients without infection during 30 day follow-up after radical cystectomy.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pomeranian Medical University Szczecin

OTHER

Sponsor Role lead

Responsible Party

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Krystian Kaczmarek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Urology and Urological Oncology

Szczecin, West Pomeranian Voivodeship, Poland

Site Status

Countries

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Poland

Other Identifiers

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INF1

Identifier Type: -

Identifier Source: org_study_id