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Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultrasound imaging
robot-assisted laparoscopic surgery
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (TRUS)

Arm Description

Patients undergo TRUS during RALP.

Outcomes

Primary Outcome Measures

Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2011
Last Updated
January 27, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01495130
Brief Title
Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery
Official Title
Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot clinical trial studies mechanically-manipulated ultrasound in finding tumors during robotic-assisted surgery in patients with prostate cancer. Diagnostic procedures, such as ultrasound, may help find prostate cancer and find out how far the disease has spread during surgery
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (TRUS)
Arm Type
Experimental
Arm Description
Patients undergo TRUS during RALP.
Intervention Type
Procedure
Intervention Name(s)
ultrasound imaging
Other Intervention Name(s)
ultrasonography, ultrasound, ultrasound test
Intervention Description
Undergo transrectal ultrasound
Intervention Type
Procedure
Intervention Name(s)
robot-assisted laparoscopic surgery
Intervention Description
Undergo robotic-assisted laparoscopic prostatectomy
Primary Outcome Measure Information:
Title
Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.
Time Frame
7 days post-RALP

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Ukimura
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States

12. IPD Sharing Statement

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Transrectal Ultrasound (TRUS) in Finding Tumors During Robotic-Assisted Laparoscopic Surgery

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