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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01495130
First received: November 29, 2011
Last updated: January 17, 2013
Last verified: January 2013
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495130

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

No publications provided

Responsible Party: USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01495130     History of Changes
Other Study ID Numbers: 4P-10-9, NCI-2011-03570
Study First Received: November 29, 2011
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013