Title:
Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy
Protocol Number:
J0937
Phase:
Phase I
Physician:
Misop Han
Purpose:
A new solution for guiding the surgeon in robot-assisted laparoscopic radical prostatectomy (RALP) is image-guided navigation using transrectal ultrasound (TRUS). A TRUS-guided intraoperative navigation system using a robotic ultrasound probe manipulator (TRUS Robot) has been developed. The proposed research is a pilot clinical trial of the TRUS Robot and three-dimensional (3-D) navigation software to test its image-guidance ability of helping the surgeon during RALP. This is a dual robot approach, a Tandem-RALP (T-RALP). The TRUS Robot allows a steady holding as well as remote manipulation of the TRUS probe. In addition, the TRUS Robot can track the accurate position of TRUS probe which allows 3-D reconstruction of the images. While the intraoperative TRUS findings will not be used in surgical decision making in this trial, the use of TRUS imaging during radical prostatectomy can potentially improve the visualization of the the neurovascular bundle (NVB) and subsequently improve postoperative recovery of potency in men. In addition, the 3-D reconstruction images of the prostate gland can potentially provide clear and accurate guidance of surgical landmarks to the surgeon.
Eligibility:
Inclusion Criteria: Patients must be scheduled for a robotic LRP Patients must be between the ages of 35 and 75 Patients must not have one of the listed exclusion criteria Patients must be able to understand and willing to adhere to the study protocol Patients must have a clinical stage diagnosis of T1 or T2 Patients must have a preoperative serum PSA less than 20ng/ml Patients must have a biopsy Gleason score of 5-8 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 (eg. coumadin, lovenox, or heparin) Patients with a clinical stage diagnosis of T3 - Patients with a preoperative serum PSA � 20 ng/mL Patients with a biopsy Gleason score less than 5 or greater than 8
Treatment:
During surgery, and as part of this research study, we will place the transrectal ultrasound probe (TRUS) 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. We will complete the LRP surgery as we usually do. Ultrasound probe will be removed at the end of the surgery.
Population:
Adult
Last Update
05/25/2013 04:02 AM
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