To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.
Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Urinary Continence Recovery
24-hour pad weights
Time frame: One week after the removal of the suprapubic urinary catheter
Number of Participants With Urinary Continence Recovery
0 pad per day
Time frame: within 3 months from the intervention
Number of Participants With Peri and Postoperative Complications
Clavien-Dindo complications
Time frame: 1-year median follow up
Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater)
SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of \>=22 is normal and \>=17 is considered mild ED
Time frame: 1-year median follow up
Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml)
Patients without biochemical evidence of disease recurrence (i.e. postop PSA \>=0.2 ng/mL)
Time frame: 1-year median follow up
Post-operative Urinary Function and Urinary Function-related Quality of Life
International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)
Time frame: Within 3 months from the intervention
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