Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Single-Center Randomized Study Of Single-Port Versus Multi-Port Robotic Radical Prostatectomy

Conditions
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Malignant Neoplasm of Prostate

Intervention / Treatment
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* Device: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy
* Device: Da Vinci ® SP system - SP Robotic Radical Prostatectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extraperitoneal SinglePort (SP) Robotic Radical Prostatectomy (Da Vinci ® SP system)<br>All participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® SP system. Access point consists of one 3.5 cm single infraumbilical incision for the SP-RARP | Device: Da Vinci ® SP system - SP Robotic Radical Prostatectomy<br>* 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<br>|
| Active Comparator: Extraperitoneal MultiPort (MP) Robotic Radical Prostatectomy (Da Vinci ® Xi system)<br>All participants will undergo SOC robotic radical prostatectomy. The procedure for this arm uses the Da Vinci ® Xi system, where four 8mm trocars will be used along with a 12 mm assistant trocar (a surgical instrument) to create six small incisions during the surgery | Device: Da Vinci ® Xi system - MP Robotic Radical Prostatectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of Urinary Continence Following Catheter Removal | Continence will be defined as the absence of pads (even safety pads). | Up to 12 months post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body image questionnaire scores | Body image perception, measured using the body image questionnaire, which consists of two sub-scales: the body image scale, which assesses attitudes to bodily appearance and consists of five questions (score 5-20) where higher scores mean worse outcomes, and the cosmetic scale which assesses the degree of satisfaction with the appearance of the scar and consists of three questions (score 3-24), where higher scores mean worse outcomes. | Up to 1 year | 
| Participant and Observer Scar Assessment Scale scores | Scar evaluation by using a validated assessment tool, the Participant and Observer Scar Assessment Scale.17 It consists of two scales: the observer scale and the participant scale (Figs. 1 and 2). Both scales contain six items that are scored numerically. Each of the six items on both scales has a 10-step score, with 10 indicating the worst imaginable scar or sensation. The total score of both scales consists of adding the scores of each of the six items (range, 6 to 60). The lowest score, 6, reflects normal skin, whereas the highest score, 60, reflects the worst imaginable scar. | Up to 1 year | 
| Number of pads used daily | Urinary continence, assessing the number of pads used daily. Continence will be defined as the absence of pads (even safety pads) | Up to 1 year | 
| International Index of Erectile Function (IIEF-5) scale scores | Erectile Function assessed by the IIEF-5 scale, consisting of 5 questions, with scores ranging from 5-25. 25 being great and 5 being the worst | Up to 1 year | 
| Time to return-to-work | Time to return-to-work, reported in days | Up to 1 year | 
| Time to baseline | Time to baseline defined as the amount of time between surgery and when the patient becomes pain free and does not need painkillers | Up to 1 year | 
| Hospital stay in hours | Hospital stay, counted in hours from the time of transfer to the post anesthesia care unit (PACU) to discharge | Post-surgery, an average of 16 hours | 
| Operative time | Time elapsed from skin incision to placement of the final skin suture | During operation, an average operative time is 192 minutes | 
| Estimated blood loss in milliliters | Estimated blood loss, measured in volume (mL) | During operation, an average operative time is 192 minutes | 
| Number of additional ports | Number of additional ports needed in surgery | 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 | Within 24 hours of surgery | 
| Intraoperative complication rate | Intraoperative complication rate compared between the two systems | 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 | Within 24 hours of surgery | 
| Intraoperative peritoneum breach rate | Intraoperative peritoneum breach rate as defined by intraoperative pneumoperitoneum after insufflation of extraperitoneal space | Within 24 hours of surgery | 
| Visual analog pain scale scores | Pain intensity will be evaluated with a visual analog pain scale, a validated instrument scored from 0 to 10, 10 being the worst | Within 7 days of surgery | 
| Units of parenteral morphine equivalents (mg) | Analgesic requirements will be obtained from medical charts and reported as units of parenteral morphine equivalents (mg) | Up to 1 month post-procedure | 
| Time to liquid oral intake | Time to liquid oral intake | Post-surgery, an average of 16 hours | 
| Time to solid oral intake | Time to solid oral intake | Post-surgery, an average of 16 hours | 
| Number of postoperative complications | Postoperative complications recorded according to the Clavien- Dindo classification | Within 30 days |