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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-05-31

Brief Summary

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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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Detailed Description

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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

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Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control arm

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Group Type ACTIVE_COMPARATOR

Vattikuti Urology Institute radical prostatectomy

Intervention Type PROCEDURE

Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

da Vinci Surgical System

Intervention Type DEVICE

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.

Treatment arm

Retzius sparing radical prostatectomy da Vinci Surgical System

Group Type EXPERIMENTAL

Retzius sparing radical prostatectomy

Intervention Type PROCEDURE

Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

da Vinci Surgical System

Intervention Type DEVICE

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.

Interventions

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Retzius sparing radical prostatectomy

Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

Intervention Type PROCEDURE

Vattikuti Urology Institute radical prostatectomy

Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients with newly diagnosed prostate cancer undergoing robotic-assisted radical prostatectomy at the Vattikuti Urology Institute (performed by single surgeon, MM) as the primary treatment modality
* Be able to read and speak English and be able to provide written informed consent

Exclusion Criteria

* patients with high risk prostate cancer,defined as a biopsy Gleason score ≥8 and/or a pre-operative prostate specific antigen value ≥20 ng/ml.
* evidence of clinical nodal involvement (cN1) or metastatic disease (M1)
* patients participating in a competing study
* patients with pre-operative urinary incontinence.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No