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Transrectal Ultrasound (TRUS) Imaging of the Prostate Gland and Neurovascular Bundles (NVB) During Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP)

Phase 0
35 Years
75 Years
Not Enrolling
Prostate Cancer

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Trial Information

Transrectal Ultrasound (TRUS) Imaging of the Prostate Gland and Neurovascular Bundles (NVB) During Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP)

During surgery for prostate cancer, precise resection of the tumor-containing prostate gland
and preservation of the neurovascular bundle (NVB) are critical in preventing tumor
recurrence and potency preservation following surgery. However, due to the periprostatic
connective tissues and bleeding, it is difficult to visualize NVB during surgery, even with
surgical loupes or laparoscopic magnification.

Ultrasound (US) is commonly used in imaging the prostate during diagnostic and therapeutic
procedures such as diagnostic biopsy. US image in addition to the classic laparoscopic
imaging can potentially provide decreased surgical margins and improve the dissection of the
NVB during laparoscopic radical prostatectomy (LRP) according to the study by the Cleveland
Clinic group. In their study, an assistant manipulated the TRUS probe under the direction of
the surgeon and held it in place as requested. At critical points of the surgery, the
surgeon visualized the NVB on the Doppler-capable ultrasound monitor. The images, however,
were difficult to interpret because the surgeon was not in direct control of the TRUS probe.
In addition, it was challenging for surgeon to communicate with the assistant to obtain
steady and useful image. Moreover, their study was performed exclusively in LRP without the
daVinciĀ® robot (Intuitive Surgical, Inc.), more commonly performed surgical approach for
radical prostatectomy.

To overcome these obstacles in the study by Ukimura and al., we propose to use a mechanical
support arm for holding and manipulating the TRUS probe during the daVinciĀ® robot-assisted
laparoscopic radical prostatectomy (robotic LRP)..

This application is for a feasibility study involving six patients. We will obtain TRUS
images of the prostate and NVB during a robotic LRP procedure. These images will be acquired
in the first part of the operation and performed with minimal interference to the operation.
We will record and analyze the TRUS images to investigate the feasibility of using
mechanical support arm for the TRUS probe. The proposed study is a proof of concept for a
following protocol.

Inclusion Criteria:

- Patients scheduled for a Laparoscopic Radical Prostatectomy operation

- Patients must be between the ages of 35 and 75

- Patients must not have one of the above listed exclusion criteria

- Patients must be able to understand and willing to adhere to the study protocol

Exclusion Criteria:

- Patients less than 35 years of age and over 75 years of age

- Patients with previous rectal surgery

- Patients with anal stenosis that prevents the TRUS probe insertion

- Patients with extensive abdominal surgery

- Patients with inadequate bowel prep

- Patients who are unwilling or unable to sign informed consent

- Patients on anticoagulation medication (e.g., coumadin, lovenox, or heparin)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Misop Han, M.D., M.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins Medical Institutions


United States: Institutional Review Board

Study ID:




Start Date:

November 2008

Completion Date:

December 2009

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Transrectal Ultrasound Imaging of Prostate
  • Neurovascular Bundles
  • Robot Assisted Laparoscopic Radical Prostatectomy
  • Prostatic Neoplasms



Johns Hopkins HospitalBaltimore, Maryland  21287