Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Case Comprehensive Cancer Center

Overview

The purpose of this study is to compare two different techniques to perform the standard of care surgery to treat prostate cancer. This surgery is called robotic radical prostatectomy. There are two robotic surgical systems approved by the Food and Drug Administration (FDA) to perform this surgery. First system is called the Da Vinci ® Xi system. With this system, six small incisions are made during the surgery. Second system is called the Da Vinci ® SP system. With this system a single incision is made during the surgery. Same surgery is done with each surgical system. This study aims to understand whether a single incision surgery ends up with better recovery after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Malignant Neoplasm of Prostate

Interventions

Da Vinci ® Xi system - MP Robotic Radical ProstatectomyDEVICE

After pneumoperitoneum is established, four 8mm, one 12 mm, and one 5 mm trocars are placed for instrumentation. After the robot is docked, radical prostatectomy is performed with the SOC approach.

Da Vinci ® SP system - SP Robotic Radical ProstatectomyDEVICE

After induction of general anesthesia and supine participant positioning, a 3.5 cm infraumbilical incision will be made for single-port access into the space of Retzius. Radical prostatectomy is then performed with the SOC approach

Eligibility

Sex: MALEMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must have histologically or cytologically confirmed prostate cancer, stage T1a, T2a or T2b prostate cancer using MRI staging. * Life expectancy greater than 10 years. * Participants must have ability to understand and the willingness to sign a written informed consent document or have a surrogate with the ability to understand and the willingness to sign a written informed consent for radical prostatectomy. Exclusion Criteria: * Participants with any prior extensive pelvic surgery or pelvic fractures. * Prior treatment for prostate cancer such as radiotherapy or focal therapy. * Uncorrected coagulopathy. * Active soft tissue or urinary infection. * Poor surgical risk (defined as American Society of Anesthesiology score \> 3) * Any condition or history of illness or surgery that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the patient (e.g. significant cardiovascular conditions that significantly affect the life expectancy, chronic opiate use, pain syndrome, or drug abuse.) * Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Locations (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Recovery of Urinary Continence Following Catheter Removal

Continence will be defined as the absence of pads (even safety pads).

Time frame: Up to 12 months post-treatment

Secondary Outcomes

Operative time

Time elapsed from skin incision to placement of the final skin suture

Time frame: During operation, an average operative time is 192 minutes

Estimated blood loss in milliliters

Estimated blood loss, measured in volume (mL)

Time frame: During operation, an average operative time is 192 minutes

Number of additional ports

Number of additional ports needed in surgery

Time frame: Within 24 hours of surgery

Number of SP procedures converted to other procedure types

For SP procedures, conversion to MP robotic surgery or standard laparoscopic surgery, or open surgery will be recorded

Time frame: Within 24 hours of surgery

Intraoperative complication rate

Intraoperative complication rate compared between the two systems

Time frame: Within 24 hours of surgery

Number of participants requiring Intraoperative Trendelenburg position

Intraoperative Trendelenburg position requirement for the participant will be recorded. Position involves placing the head low and feet elevated, increasing blood return to the heart, cardiac output and vital organ perfusion

Time frame: Within 24 hours of surgery

Data from ClinicalTrials.gov

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