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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| ShuGuang Hospital | OTHER |
| Eastern Hepatobiliary Surgery Hospital | OTHER |
| The First Affiliated Hospital of Guangzhou Medical University |
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This study is a two-arm, multicenter, randomized controlled clinical trial on whether single-port extraperitoneal VIP RARP is non-inferior to multi-port transperitoneal RARP in terms of functional recovery rate and other key metrics.
Multicenter enrollment of 480 patients with localized prostate cancer meeting enrollment criteria are randomized to undergo either single-port robotic extraperitoneal VIP radical prostatectomy or multi-port robotic transperitoneal bilateral intrafascial radical prostatectomy for perioperative data recording, treatment, and monitoring with 1 year follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-port extraperitoneal RARP | Experimental | Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy (VIP) techniques |
|
| Multi-port transperitoneal RARP | Active Comparator | Multi-port transperitoneal RARP with bilateral intrafascial nerve-sparing techniques |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques | Procedure | Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive single-port extraperitoneal robotic-assisted radical prostatectomy with Vattikuti Institute Prostatectomy(VIP) techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Potency recovery rate | Potency recovery rate 3 months postoperatively, based on the patient's description of whether the erection is firm enough for sexual activity or intercourse. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Continence recovery rate | The rate of recovery of continence postoperatively, measured in the number of pads used per day. | Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively |
| PSA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shancheng Ren, MD/PhD | Contact | 139 1779 3885 | renshancheng@gmail.com | |
| Yi fan Chang | Contact | 13661652533 | 13661652533@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changzheng hospital | Recruiting | Shanghai | Shanghai Municipality | 201109 | China |
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| OTHER |
| Sir Run Run Shaw Hospital | OTHER |
| Sichuan Provincial People's Hospital | OTHER |
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|
| Multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques | Procedure | Patients with localized prostate cancer are randomized into this group in a 1:1 ratio and receive multi-port transperitoneal robotic-assisted radical prostatectomy with bilateral intrafascial nerve-sparing techniques. The investigators will monitor patients for perioperative data recording, treatment and 1-year follow-up. |
|
PSA status postoperatively,measured in ng/mL
| Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively |
| Potency recovery rate | Potency recovery rate will be assessed by patient's self-reported erectile firmness for sexual activity or intercourse, International Index of Erectile Dysfunction(IIEF-5) score(from 0-25 score, a higher score means a worse outcome), and phosphodiesterase5 (PDE-5)inhibitor intake frequency according to patients' despciption (a higher intake means a worse outcome). | Up to 1 year, at a frequency of 1, 6, and 12 months postoperatively |
| Clavien-Dindo complication score | Clavien-Dindo complication score measured in the following grades(a higher grade means a worse outcome) : First grade:complications that do not require medication, surgery or endoscopic treatment. Second grade: complications require to be treated with drugs, including blood transfusion and parenteral nutrition. Third grade: complications that require surgery, endoscopy, or radiation therapy. Fourth grade: the emergence of life-threatening complications, including cerebral hemorrhage, etc., which is also divided into 4a and 4b, 4a is single-organ dysfunction, 4b is mainly multi-organ dysfunction and injury. Fifth grade: death. | Every day during period of hospitalization (up to 7 days) |
| Operative time | Time elapsed from skin incision to placement of the final skin suture, measured in minutes | During operation(on an average of 90-120minutes ) |
| Estimated blood loss | Estimated blood loss, measured in volume (mL) | During operation(on an average of 90-120minutes ) |
| Number of additional ports | Number of additional ports needed in surgery | During operation(on an average of 90-120minutes ) |
| Period of hospitalization | Hospital stay, counted in days from the first day of hospitalization to discharge | During period of hospitalization (up to 7 days) |
| Period of hospitalization post surgery | Hospital stay, counted in days from the time of transfer to the post anesthesia care unit (PACU) to discharge | Post surgery, during period of hospitalization (up to 7 days) |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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