Retzius sparing radical prostatectomy
ProcedureRobotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
NCT Number: NCT02352103
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.
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Notify Me40 year–75 year
Male
Interventional
Phase 3
Henry Ford Hospital, Detroit, Michigan, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: One week after the removal of the suprapubic urinary catheter
24-hour pad weights
Time frame: within 3 months from the intervention
0 pad per day
Time frame: 1-year median follow up
Clavien-Dindo complications
Time frame: 1-year median follow up
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
Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL)
Time frame: Within 3 months from the intervention
International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function)
Time frame: 1 year median follow up
0 pad per day
Time frame: 1 year median follow up
MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function
Henry Ford Health System
Other
The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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