VTI Doppler Probe For Robotic Surgery
18 Years
N/A
Male
Prostate Cancer, Nerve Sparing Prostatectomy
Trial Information
VTI Doppler Probe For Robotic Surgery
The VTI Laparoscopic Doppler System is a blood flow detector that compensates for the loss
of tactile sensation during laparoscopic procedures by helping the surgeon to identify
vascular anatomy before it is visible to the eye. The system's sterile doppler probes fit
through standard 5mm ports. It is simple to use and no special training is required. This
study is designed to evaluate the use of the VTI (Nashua, NH) 20 megahertz (MHz)
Microvascular Doppler probe in laparoscopic urological surgery.
Patients will take a preoperative sexual health inventory for men (SHIM) questionnaire. The
investigators will then assess presence or absence of arterial and venous blood flow, in
real-time during surgery. Additionally, the investigators will evaluate the safety of
Doppler probe use, the surgical margin status on final pathology, and the post-operative
erectile function of the patients with a followup SHIM questionnaire (to be performed 3
months after surgery). Finally, the robotic surgeon will document whether or not our
original surgical plan was changed or remained the same after the Doppler use.
Inclusion Criteria:
- All patients must be 18 years of age or older and be able to read, understand and
sign consent.
- Any patient undergoing robotic assisted laparoscopic prostatectomy (RALP)
- Any patient without moderate or severe erectile dysfunction (SHIM less than 15)
undergoing bilateral or unilateral nerve-sparing RALP is eligible for this procedure.
Exclusion Criteria:
- Patients undergoing a non nerve-sparing RALP will be excluded from this study
- Those who receive a baseline SHIM score less than 15
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Outcome Measure:
Change in SHIM Score (score of erectile function) following surgery
Outcome Description:
Patients are to be evaluated for erectile function at 8 month post-operative visit using validated SHIM questionnaire.
Outcome Time Frame:
8 months post-operative follow-up
Safety Issue:
No
Principal Investigator
Ketan Badani, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia University
Authority:
United States: Food and Drug Administration
Study ID:
AAAF3321
NCT ID:
NCT01794936
Start Date:
August 2011
Completion Date:
April 2012
Related Keywords:
- Prostate Cancer
- Nerve Sparing Prostatectomy
- Prostate cancer
- Nerve Sparing Prostatectomy
- VTI Probe
- Prostatic Neoplasms
Name | Location |
|---|---|
| Columbia University Medical Center | New York, New York 10032 |
