NCT02526589

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2017

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

2.1 years

First QC Date

August 10, 2015

Last Update Submit

January 7, 2018

Conditions

Prostatic NeoplasmAnastomosis

Outcome Measures

Primary Outcomes (1)

  • Urine colour

    correlation of urine colour to cystogram finding

    1 week

Eligibility Criteria

Age18 Years - 90 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Robotic assisted laparoscopic radical prostatectomy patients. Catheter removal visit.

You may qualify if:

  • Previous robotic radical prostatectomy
  • Catheter removal visit

You may not qualify if:

  • No urine in urinary collecting bag

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, Finland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Jarno Riikonen, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2015

First Posted

August 18, 2015

Study Start

August 1, 2015

Primary Completion

September 20, 2017

Study Completion

September 20, 2017

Last Updated

January 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)