Transrectal Ultrasound Imaging of the Prostate Gland and Neurovascular Bundles During Robot-Assisted Laparoscopic Radical Prostatectomy

Stopped early · Early Phase 1

Conditions studied: Prostate Cancer

In brief

Neurovascular bundle (NVB) contains capsular vessels to the prostate and cavernous nerves that provides the macroscopic landmark used during nerve-sparing radical prostatectomy. The preservation of NVB during radical prostatectomy improves postoperative recovery of potency and continence. However, the visualization of the NVB during radical prostatectomy can be challenging. Recently, an attempt has been made to use a transrectal ultrasound (TRUS) imaging to delineate the anatomy of the prostate gland and NVB during laparoscopic radical prostatectomy. However, it is difficult to obtain a steady image of TRUS with an operator. The investigators plan to perform a feasibility study to obtain TRUS imaging of the prostate and NVB during robot-assisted laparoscopic radical prostatectomy (RALRP). The investigators plan to use a robot-assisted TRUS probe holder to gently manipulate the probe to obtain steady TRUS images that may aid in visualization and dissection of the NVB during RALRP.

Key facts

Study ID

NCT00952666

Run by

Johns Hopkins University

People needed

6

Starts

2008-11-01

Expected to finish

2009-12-01

Last updated by the study team

2010-09-13

Who can join

Age: 35 and older, up to 75. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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