Does Bloody Urine Predict Urethrovesical Anastomosis Leakage After Radical Prostatectomy

January 7, 2018 updated by: Tampere University Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

226

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

  • Finland
      • Tampere, Finland
        • Tampere University Hospital

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Robotic assisted laparoscopic radical prostatectomy patients. Catheter removal visit.

Description

Inclusion Criteria:

  • Previous robotic radical prostatectomy
  • Catheter removal visit

Exclusion Criteria:

  • No urine in urinary collecting bag

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine colour
Time Frame: 1 week
correlation of urine colour to cystogram finding
1 week

Collaborators and Investigators

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

Sponsor

Tampere University Hospital

Investigators

  • Principal Investigator: Jarno Riikonen, MD, Tampere University Hospital

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

August 1, 2015

Primary Completion (Actual)

September 20, 2017

Study Completion (Actual)

September 20, 2017

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 14, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 7, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R15042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

Clinical Trials on Prostatic Neoplasm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe