Prostate and Kidney Cancer
Conditions
Brief summary
To determine the feasibility of representative urologic procedures as measured by the rate of conversions
Interventions
DEVICEda Vinci Sp Surgical System - Robotic
robotic assisted laparoscopic single-port system
Sponsors
Intuitive Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine the feasibility as measured by the rate of conversions | Intra Operative | Rate of Conversion to Open approach |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative surgical outcomes | From admission to discharge from the hospital for the primary procedure typically up to 7 days | Perioperative surgical outcomes length of hospital stay- From admission to discharge from the hospital for the primary procedure |
| Perioperative Surgical outcomes | Intra-operative | Rate of Transfusion |
| Perioperative Surgical Outcomes | 30 day, 1 year , 2 year and 3 year follow up | Procedure specific wound complications , infection |
| Post-operative - Continence | 1 year, 2 year and 3 year follow up | Continence measured by use of pads |
| Perioperative Surgical Outcome- potency | 1 , 2 and 3 year follow up | Potency rate administered by International Index of Erectile Function patient questionnaire |
Countries
France
Outcome results
None listed