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

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT02001597
• Lead Sponsor: University of British Columbia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Study First Submitted: 2013-11-22
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-04
• Last Update Submitted: 2013-12-04
• Study First Posted: 2013-12-05
• Last Update Posted: 2013-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada