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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Prostate Cancer

Keywords

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surgery robotic ultrasound guidance endorectal

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgery patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Septimiu E. Salcudean

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Vancouver General Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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385902-2010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H11-02267

Identifier Type: -

Identifier Source: org_study_id