The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Performance of da Vinci SP System on Extraperitoneal Approach Radical Prostatectomy-a Single Arm Pivotal Trial Initiated by Chang Gung Memorial Hospital, Taiwan

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: da Vinci SP system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with biopsy-proved prostate cancer Stage clinical T1-T2N0M0 Prostate volume ≦ 70cm (by transrectal ultrasound or other image studies) BMI ≦ 35 kg/m Low priority of nerve sparing (pre-op sexual dysfunction or don't care about sexual function) Age between 18 and 78 years old Suitable for minimally invasive surgery Patients willing and able to provide informed consent Patients willing and able to comply with study protocol requirements and follow-up Exclusion Criteria: Previous abdominal or pelvic major operation history Previous radiation treatment to the pelvic area Patients received transurethral resection of prostate in three months 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) Anatomy unsuitable for endoscopic visualization or minimally invasive surgery Hemodynamic or respiratory instability after anesthesia Working space restriction (e.g. kyphosis or severe scoliosis) Emergency surgery Untreated active infection vulnerable populations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 78 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study arm<br>Patients with prostate cancer | Device: da Vinci SP system<br>* using da Vinci SP system to perform extraperitoneal approach radical prostatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate (%) | 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.) | immediately after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative parameters-incision length (cm) | incision length | immediately after the surgery | 
| Perioperative parameters-console time (minutes) | console time | immediately after the surgery | 
| Perioperative parameters-blood loss (ml) | blood loss | immediately after the surgery | 
| Perioperative parameters-blood transfusion type | blood transfusion type | immediately after the surgery | 
| Perioperative parameters-blood transfusion unit | blood transfusion unit | immediately after the surgery | 
| Perioperative parameters-intra-operative complications (SATAVA system) | intra-operative complications accessed with SATAVA system, Grade 1 to 3, higher grade indicates serious complications | immediately after the surgery | 
| Perioperative parameters-oxidative stress | oxidative stress measured by the arterial malondialdehyde (MDA) level (micromole/L) | immediately after the surgery | 
| Postoperative parameters-length of hospital stay (days) | length of hospital stay | immediately after discharge (assessed up to 10 days) | 
| Postoperative parameters-pain scale (VAS score) | pain scale accessed with visual analog scale (VAS) score, 1-10, higher score indicates more pain | Every day during admission after the surgery (up to 7 days) | 
| Postoperative parameters-analgesic type | analgesic type | Every day during admission after the surgery (up to 7 days) | 
| Postoperative parameters-analgesic dose | analgesic dose | Every day during admission after the surgery (up to 7 days) | 
| Postoperative parameters-postoperative complications (CLAVIEN-DINDO system) | postoperative complications accessed with CLAVIEN-DINDO system, Grade I to V, higher grade indicates severe complications | During admission after the surgery (up to 10 days) | 
| Postoperative parameters-readmission and reoperation | Thirty-day readmission and reoperations in relation to the index procedure | If happens, on the day of re-admission or reoperations (up to 30 days) | 
| Functional outcomes-continence status | 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. | Post-operation 1/3/6/12 months | 
| Functional outcomes-continence (pad amount) | pads used per day (for patients with incontinence) | Post-operation 1/3/6/12 months | 
| Functional outcomes-continence (leak amount in gram) | 24hr total weight of pads (for patients with incontinence) | Post-operation 1/3/6/12 months | 
| Functional outcomes-sexual function change (IIEF-5) | 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. | Baseline, Post-operation 1/3/6/12 months | 
| Oncologic outcomes-margin status (positive or negative) | surgical margin status | when the pathology report is available (up to day 10) | 
| Oncologic outcomes-biochemical recurrence | biochemical recurrence (PSA level ng/ml) | Post-operation 1/3/6/12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, radical prostatectomy, da Vinci SP system, extraperitoneal approach