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

NCT00952666 | Terminated Early Phase 1 DMC

• 1 other identifier: NA_00014120
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Transrectal Ultrasound Imaging of Prostate; Neurovascular Bundles; Robot Assisted Laparoscopic Radical Prostatectomy

Study Arms (1)

Device

EXPERIMENTAL

Both the Robot-Assisted Laparoscopic Radical Prostatectomy (RALRP) and the Transrectal Ultrasound (TRUS) are common performed procedures, but are normally performed separately. In this proposed feasibility study, the procedures will be combined.

Device: TRUS-RALRP

Interventions

TRUS-RALRP DEVICE

During surgery, and part of this research study, the ultrasound probe (TRUS) will be placed in the rectum. Then, using the mechanical support arm to hold and adjust the probe we will take ultrasound images during a portion of the robotic LRP surgery. The ultrasound probe will then be removed, and we will complete the LRP surgery as we usually do. We expect this to add approximately 20 minutes to the regular surgery time; the maximum added time will be 30 minutes.

Also known as: TRUS support arm with daVinci robot

Device

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for a Laparoscopic Radical Prostatectomy operation
• Patients must be between the ages of 35 and 75

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Misop Han, M.D., M.S.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 13, 2010

Record last verified: 2009-08

Locations

US (1)