Cystostomy Infection Clinical Trial
Official title:
Incidence of and Risk Factors for Perioperative Infection Among Patients Undergoing Radical Cystectomy
| Verified date | September 2017 |
| Source | Pomeranian Medical University Szczecin |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 133 |
| Est. completion date | August 30, 2017 |
| Est. primary completion date | August 20, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Poland | Department of Urology and Urological Oncology | Szczecin | West Pomeranian |
| Lead Sponsor | Collaborator |
|---|---|
| Pomeranian Medical University Szczecin |
Poland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with perioperative infection after radical cystectomy. | 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 | Association between perioperative infection after radical cystectomy and patients' age. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and sex. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and length of hospital stay. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and body mass index. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and diabetes. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and hypertension. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and estimated glomerular filtration rate | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and preoperative hydronephrosis. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and smoking status. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and neoadjuvant chemotherapy. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and pathological stage. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and lymph node involvement. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and types of urinary diversion. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and operative method (open/laparoscopic). | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and operative time. | Logistic regression analysis. | 30 days | |
| Secondary | Association between perioperative infection after radical cystectomy and receipt of a perioperative blood transfusion. | Logistic regression analysis. | 30 days |