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

Prostate Cancer Clinical Trial

Official title:

Mechanically-Manipulated Transrectal Ultrasound (TRUS) During Robotic-Assisted Laparoscopic Prostatectomy (RALP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495130
• Other study ID #: 4P-10-9
• Secondary ID: NCI-2011-03570
• Status: Completed
• Phase: N/A
• First received: November 29, 2011
• Last updated: January 27, 2014
• Start date: October 2011
• Est. completion date: December 2012

Study information

• Verified date: January 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Procedure:
• ultrasound imaging
Undergo transrectal ultrasound
• robot-assisted laparoscopic surgery
Undergo robotic-assisted laparoscopic prostatectomy

Locations

Country	Name	City	State
United States	USC/Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.		7 days post-RALP	No