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

University of Southern California

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: robot-assisted laparoscopic surgery; Procedure: ultrasound imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01495130

4P-10-9

NCI-2011-03570 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 11 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 1 patient group

Diagnostic (TRUS)

Experimental group

Description:

Patients undergo TRUS during RALP.

Treatment:

Procedure: ultrasound imaging

Procedure: robot-assisted laparoscopic surgery