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NCT02526589 Clinical Trial

Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy

Prostatic Neoplasm Clinical Trial

Official title:
Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02526589
Other study ID # R15042
Secondary ID
Status Completed
Phase N/A
First received August 10, 2015
Last updated January 7, 2018
Start date August 2015
Est. completion date September 20, 2017

Study information
Verified date January 2018
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Traditionally the watertightness of urethrovesical anastomosis after robotic radical prostatectomy is controlled by cystogram. However, clinical observations and one previous study showed that patients with anastomotic leakage have red coloured urine. If the investigators can verify this finding, the most of the cystograms can be avoided. In this study the investigators estimate urine colour after cystogram and take a picture from urine collecting pag. Later on the pictures are digitally analyzed and compared to cystogram finding.

Recruitment information / eligibility
Status Completed
Enrollment 226
Est. completion date September 20, 2017
Est. primary completion date September 20, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Previous robotic radical prostatectomy

- Catheter removal visit

Exclusion Criteria:

- No urine in urinary collecting bag

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Finland Tampere University Hospital Tampere

Sponsors (1)
Lead Sponsor Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Urine colour correlation of urine colour to cystogram finding 1 week
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