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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Patients with prostate cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci SP system | Device | using da Vinci SP system to perform extraperitoneal approach radical prostatectomy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative parameters-incision length (cm) | incision length | immediately after the surgery |
| Perioperative parameters-console time (minutes) | console time |
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Inclusion Criteria:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Po-Hung Lin, MD | Contact | +886975366240 | m7587@cgmh.org.tw | |
| Hung-Jen Wang, MD | Contact | +886975356239 |
| Name | Affiliation | Role |
|---|---|---|
| Chun-Te Wu, Professor, MD, PhD | Chang Gung Memorial Hospital at Keelung | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Recruiting | Taoyuan City | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41315721 | Derived | Lin PH, Wang HJ, Kan HC, Pang ST, Yu KJ, Wu CT. Comparable oncological and functional outcomes of robot-assisted radical prostatectomy with conventional anterior approach and Hood technique using DAVINCI SP system. Sci Rep. 2025 Nov 28;15(1):45652. doi: 10.1038/s41598-025-30245-5. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |