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OpenTrials
Completed

NCT Number: NCT02001597

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

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.

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Key information

Sex eligibility

Male

Study type

Observational

Primary location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates

    Time frame: 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 outcomes

  1. Successful prostate visualization

    Time frame: 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 outcomes

  1. Impact on completion time

    Time frame: 1 year

    We will report the total additional ultrasound set-up time for each of the patients.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • British Columbia Innovation Council
  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: TRUS-RP

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 5, 2013
Registry last updated
Dec 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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