Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)
18 Years
N/A
Male
Prostate Cancer
Trial Information
Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)
PRIMARY OBJECTIVES: I. To assess the feasibility and limitations of using a
mechanically-manipulated transrectal ultrasound (TRUS) probe for TRUS evaluation during a da
Vinci robotic-assisted laparoscopic prostatectomy (RALP). II. To collect TRUS evaluation
data during RALP to guide us in deciding whether and how the mechanical manipulation of the
TRUS probe will allow sufficient clarity of ultrasound imaging. OUTLINE: Patients undergo
TRUS during RALP. After the completion of study treatment, patients are followed up at 7
days.
Inclusion Criteria:
- Undergoing Robotic Assisted Laparoscopic Prostatectomy
Exclusion Criteria:
- Known or discovered rectal pathology
- Bleeding hemorrhoids
- Rectal stenosis
- Any prior rectal surgeries
- Prior rectal radiation
- Any known rectal disease
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.
Outcome Time Frame:
7 days post-RALP
Safety Issue:
No
Principal Investigator
Osamu Ukimura
Investigator Role:
Principal Investigator
Investigator Affiliation:
USC/Norris Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
4P-10-9
NCT ID:
NCT01495130
Start Date:
October 2011
Completion Date:
December 2012
Related Keywords:
- Prostate Cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| USC/Norris Comprehensive Cancer Center | Los Angeles, California 90033-0800 |
