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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
480
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.
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.
Changzheng hospital
Shanghai, Shanghai Municipality, China
RECRUITINGPotency 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.
Time frame: 3 months after surgery
Continence recovery rate
The rate of recovery of continence postoperatively, measured in the number of pads used per day.
Time frame: Up to 1 year, at a frequency of 1, 3, 6, and 12 months postoperatively
PSA
PSA status postoperatively,measured in ng/mL
Time frame: 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).
Time frame: 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.
Time frame: Every day during period of hospitalization (up to 7 days)
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Operative time
Time elapsed from skin incision to placement of the final skin suture, measured in minutes
Time frame: During operation(on an average of 90-120minutes )
Estimated blood loss
Estimated blood loss, measured in volume (mL)
Time frame: During operation(on an average of 90-120minutes )
Number of additional ports
Number of additional ports needed in surgery
Time frame: During operation(on an average of 90-120minutes )
Period of hospitalization
Hospital stay, counted in days from the first day of hospitalization to discharge
Time frame: 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
Time frame: Post surgery, during period of hospitalization (up to 7 days)