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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01495130
First Posted: December 19, 2011
Last Update Posted: January 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Southern California
  Purpose
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

Condition Intervention
Prostate Cancer Procedure: ultrasound imaging Procedure: robot-assisted laparoscopic surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diagnostic (TRUS)
Patients undergo TRUS during RALP.
Procedure: ultrasound imaging
Undergo transrectal ultrasound
Other Names:
  • ultrasonography
  • ultrasound
  • ultrasound test
Procedure: robot-assisted laparoscopic surgery
Undergo robotic-assisted laparoscopic prostatectomy

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495130


Locations
United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Cancer Institute (NCI)
Investigators
Principal Investigator: Osamu Ukimura University of Southern California
  More Information

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01495130     History of Changes
Other Study ID Numbers: 4P-10-9
NCI-2011-03570 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: November 29, 2011
First Posted: December 19, 2011
Last Update Posted: January 29, 2014
Last Verified: January 2014