Prospective Investigation of Robotic Single-port System

Study Overview
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Brief Summary
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To determine the feasibility of representative urologic procedures as measured by the rate of conversions

Conditions
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Prostate and Kidney Cancer

Intervention / Treatment
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* Device: da Vinci Sp Surgical System - Robotic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Prostatectomy: Patients age 18-75 years BMI <=35 kg/m2 Confirmed localized adenocarcinoma of the prostate Suitable for minimally invasive prostate cancer surgery Nephrectomy: Patient age 18-75 years BMI <=35 kg/m2 Kidney disease amenable to nephrectomy or partial nephrectomy Suitable for minimally invasive kidney surgery Exclusion Criteria: Untreated active infection (includes local kidney infection) Vulnerable population (ex: prisoners, mentally disabled) Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions (i.e., cancer) Anatomy unsuitable for endoscopic visualization or minimally invasive surgery Patient with second primary cancer Extensive previous abdominal surgery Prior radiation treatment for prostate or kidney cancer Patient with distant metastasis Complex renal vascular anatomy Patient with kidney cancer - stage T3 or N+ M+ ** Horseshoe kidney** Previous ipsilateral kidney surgery **- specific to kidney surgery -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

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

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: da Vinci Sp Surgical System<br>da Vinci Sp Surgical System - Robotic - assisted single-port surgery | Device: da Vinci Sp Surgical System - Robotic<br>* robotic assisted laparoscopic single-port system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the feasibility as measured by the rate of conversions | Rate of Conversion to Open approach | Intra Operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative surgical outcomes | Perioperative surgical outcomes length of hospital stay- From admission to discharge from the hospital for the primary procedure | From admission to discharge from the hospital for the primary procedure typically up to 7 days | 
| Perioperative Surgical outcomes | Rate of Transfusion | Intra-operative | 
| Perioperative Surgical Outcomes | Procedure specific wound complications , infection | 30 day, 1 year , 2 year and 3 year follow up | 
| Post-operative - Continence | Continence measured by use of pads | 1 year, 2 year and 3 year follow up | 
| Perioperative Surgical Outcome- potency | Potency rate administered by International Index of Erectile Function patient questionnaire | 1 , 2 and 3 year follow up |