Status:
TERMINATED
Ultrasound-Guided Navigation in Robot-Assisted Laparoscopic Radical Prostatectomy
Lead Sponsor:
Johns Hopkins University
Conditions:
Prostate Cancer
Eligibility:
MALE
35-75 years
Phase:
EARLY_PHASE1
Brief Summary
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 navigati...
Detailed Description
The preservation of the neurovascular bundle (NVB) including cavernous nerves during radical prostatectomy improves the postoperative recovery of sexual potency. At present, the location of NVB is det...
Eligibility Criteria
Inclusion
- 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 \< 20ng/ml
- Patients must have a biopsy Gleason score of 5-8
Exclusion
- 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 \< 5 or \> 8
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00956904
Start Date
August 1 2009
End Date
June 1 2013
Last Update
June 19 2013
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287