Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02001597

Acronym

TRUS-RP

Enrollment

Registered

2013-12-05

Start date

2013-03-31

Completion date

2013-11-30

Last updated

2013-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

surgery, robotic, ultrasound, guidance, endorectal

Brief summary

Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment for prostate cancer. The state of the art radical prostatectomy involves a robotic laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D visualization of the surgical site and improved dexterity over standard laparoscopic instruments. While the long term prognosis of prostate cancer patients who undergo radical prostatectomy has improved significantly over the past two decades, there remain significant rates of disease recurrence and complications. The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be deployed and used easily during surgery, can be registered to the robot coordinate systems with high accuracy, and can be controlled from the surgeon's console, in order to improve the visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer probability map that can be used to make decisions on surgical margins. The investigators objectives are 1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical prostatectomy 2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and peri-prostatic tissue from the surgical console This is an observational study; trans-rectal ultrasound will be used to visualize the prostate and periprostatic structures during surgery but the standard of care will not be affected by this ultrasound imaging.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Healthy volunteers

Inclusion criteria

* All men who undergo robot-assisted radical prostatectomy are eligible.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates	1 year	We will measure and report the time required to carry out the registration of the ultrasound transducer relative to the da Vinci coordinate system for each of the patients.

Secondary

Measure	Time frame	Description
Successful prostate visualization	1 year	For each patient in the cohort, we will report the total time of ultrasound use and the specific context in which it was used, e.g. identification of the bladder neck, identification of rectal wall, identification of the seminal vesicles, identification of the prostate apex.

Other

Measure	Time frame	Description
Impact on completion time	1 year	We will report the total additional ultrasound set-up time for each of the patients.

Countries

Canada

Outcome results