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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Procedure: ultrasound imaging; Procedure: robot-assisted laparoscopic surgery

• Registration Number: NCT01495130
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-12-16
• Study First Posted: 2011-12-19
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (TRUS)	ultrasound imaging	Patients undergo TRUS during RALP.
Diagnostic (TRUS)	robot-assisted laparoscopic surgery	Patients undergo TRUS during RALP.

Primary Outcome Measures

Name	Time	Method
Number of patients who have negative margins when a TRUS probe is used during RALP procedure without introducing additional complications.	7 days post-RALP

Trial Locations

Locations (1)

USC/Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States