Prostate Cancer
Conditions
Keywords
prostate cancer, radical prostatectomy, da Vinci SP system, extraperitoneal approach
Brief summary
The objective of this study is to evaluate the performance and safety of da Vinci Single Port (SP) system on the surgery for extraperitoneal approach radical prostatectomy
Detailed description
Enrolled subjects would receive extraperitoneal approach radical prostatectomy using da Vinci SP system and be assessed at baseline (preoperatively), during hospitalization, and postoperatively (at 1 month +/-4 days, 3 month +/- 7 days, 6 months +/- 10 days, 12month +/-14 days). The preoperative assessment includes any diagnostic tests to confirm the subjects' cancer status and eligibility for the intervention under consideration such as transrectal or transperineal biopsy, image studies for staging including MRI/CT and bone scan, and cardiopulmonary tests to evaluate risks for anesthesia. The hospitalization assessment includes the collection of perioperative and postoperative details, conversions, and complications. The postoperative assessment includes regular follow up studies to evaluate cancer status and functional outcome (For sexual function, the International Index of Erectile Function (IIEF-5) would be recorded before and after the surgery. For continence, the number of pads per day and 24hr total weight of pads would be recorded. No pad used or one safe pad per day with net wet ≤ 50gm would be considered as continent. International Prostate Symptom Score (IPSS) wound be recorded before and after the surgery to access voiding function).
Interventions
DEVICEda Vinci SP system
using da Vinci SP system to perform extraperitoneal approach radical prostatectomy
Sponsors
Intuitive Surgical
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 78 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with biopsy-proved prostate cancer 2. Stage clinical T1-T2N0M0 3. Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies) 4. BMI ≦ 35 kg/m 5. Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function) 6. Age between 18 and 78 years old 7. Suitable for minimally invasive surgery 8. Patients willing and able to provide informed consent 9. Patients willing and able to comply with study protocol requirements and follow-up
Exclusion criteria
1. Previous abdominal or pelvic major operation history 2. Previous radiation treatment to the pelvic area 3. Patients received transurethral resection of prostate in three months 4. Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions * Severe heart disease (NYHA functional class III-IV) * Severe lung disease (GOLD Group C-D) 5. Anatomy unsuitable for endoscopic visualization or minimally invasive surgery 6. Hemodynamic or respiratory instability after anesthesia 7. Working space restriction (e.g. kyphosis or severe scoliosis) 8. Emergency surgery 9. Untreated active infection 10. vulnerable populations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate (%) | immediately after the surgery | Percentage of successful extraperitoneal approach radical prostatectomy with da Vinci SP system (no conversion to conventional laparoscopic, multiport da Vinci surgery or open surgery; addition of access port to complete the procedure would not be considered as conversion.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perioperative parameters-console time (minutes) | immediately after the surgery | console time |
| Perioperative parameters-blood loss (ml) | immediately after the surgery | blood loss |
| Perioperative parameters-blood transfusion type | immediately after the surgery | blood transfusion type |
| Perioperative parameters-blood transfusion unit | immediately after the surgery | blood transfusion unit |
| Perioperative parameters-intra-operative complications (SATAVA system) | immediately after the surgery | intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications |
| Perioperative parameters-oxidative stress | immediately after the surgery | oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L) |
| Postoperative parameters-length of hospital stay (days) | immediately after discharge (assessed up to 10 days) | length of hospital stay |
| Postoperative parameters-pain scale (VAS score) | Every day during admission after the surgery (up to 7 days) | pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain |
| Postoperative parameters-analgesic type | Every day during admission after the surgery (up to 7 days) | analgesic type |
| Perioperative parameters-incision length (cm) | immediately after the surgery | incision length |
| Postoperative parameters-postoperative complications (CLAVIEN-DINDO system) | During admission after the surgery (up to 10 days) | postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications |
| Postoperative parameters-readmission and reoperation | If happens, on the day of re-admission or reoperations (up to 30 days) | Thirty-day readmission and reoperations in relation to the index procedure |
| Functional outcomes-continence status | Post-operation 1/3/6/12 months | Continence status after Foley catheter removed. Pad-free or one safe pad used are defined as continence intact. More than one pad used is defined as post-operative incontinence. |
| Functional outcomes-continence (pad amount) | Post-operation 1/3/6/12 months | pads used per day (for patients with incontinence) |
| Functional outcomes-continence (leak amount in gram) | Post-operation 1/3/6/12 months | 24hr total weight of pads (for patients with incontinence) |
| Functional outcomes-sexual function change (IIEF-5) | Baseline, Post-operation 1/3/6/12 months | sexual function at baseline and 1/3/6/12 months with International Index of Erectile Function (IIEF-5), 0-25, higher score indicates better sexual function. |
| Oncologic outcomes-margin status (positive or negative) | when the pathology report is available (up to day 10) | surgical margin status |
| Oncologic outcomes-biochemical recurrence | Post-operation 1/3/6/12 months | biochemical recurrence (PSA level ng/ml) |
| Postoperative parameters-analgesic dose | Every day during admission after the surgery (up to 7 days) | analgesic dose |
Countries
Taiwan
Contacts
Primary ContactPo-Hung Lin, MD
Backup ContactHung-Jen Wang, MD
Outcome results
None listed