NCT02352103

Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery

The Impact of Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy on Short-term Continence Recovery: Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: Male
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
PROCEDURE	Retzius sparing radical prostatectomy	Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
PROCEDURE	Vattikuti Urology Institute radical prostatectomy	Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
DEVICE	da Vinci Surgical System	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-04-01
• Completion: 2018-05-01
• First posted: 2015-02-02
• Last updated: 2022-02-25
• Results posted: 2019-09-18

Locations

2 sites across 1 country: United States