Open Anterograde Radical Prostatectomy Compared to Open Retrograde Technique

Summary

Prospective randomized study performing open anterograde anatomical radical retropubic prostatectomy (RRP2A) using the same technique of minimally invasive surgery described by the Pasadena consensus for the procedure assisted by robot, compared with the anatomical radical prostatectomy technique described by Patrick Walsh (RRP). Recent studies have shown benefits in the minimally invasive surgical techniques approaches, laparoscopic radical prostatectomy (LRP) and, more recently, robot-assisted radical prostatectomy (RARP). These minimally invasive techniques were associated with advantages in complications, like intraoperative bleeding, transfusion rates and in earlier recovery of important genitourinary functions such as urinary continence and penile erection. But still has not been demonstrated conclusively advantages as oncological control and it is believed that there are about 200 to 250 cases of learning curve so that the rates of complications and positive surgical margins become stable and similar to the open radical prostatectomy. These facts associated with the high cost of robotic technology still have limited the generalization of this approach in many developing countries such as Brazil. While the majority of studies made by comparing the radical prostatectomy (RP), robot X laparoscopic X open, show a slight advantage in the first two, there is a significant bias in these studies, which is that the surgical technique used in each procedure differs significantly from minimally invasive and open surgical techniques. The evolution of minimally invasive radical prostatectomy was based on an entirely different anatomical benchmark of that described by Patrick Walsh. While robotics and laparoscopic techniques dissect the prostate, bladder neck and the neurovascular bundle in an antegrade way, from bladder neck to the apex, the Walsh RRP technique is completely different in several ways, the dissection is made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia, is always included with the specimen, and urethrovesical anastomosis, usually performed with multifilament interrupted suture, only for indicating the major differences. The RRP2A will be performed by incision (open surgery) and will be compared with the anatomical radical prostatectomy technique described by Patrick Walsh RRP, and performed by the same surgeons.

Conditions

• Prostatic Cancer
• Prostatic Neoplasm

Interventions

PROCEDURE

1 Retrograde radical prostatectomy RRP

This open surgical technique described by Patrick Walsh involves prostatic dissection made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia is always included with the specimen, and urethrovesical anastomosis usually performed with multifilament interrupted suture

PROCEDURE

2 Anterograde radical prostatectomy RRP2A

This open surgical techniques performing radical retropubic prostatectomy using the same technique of minimally invasive surgery, antegrade way, from bladder neck to the apex, with careful bladder neck dissection and preservation, incremental or not careful nervesparing procedures and urethrovesical anastomosis performed by monofilament running suture, described by the Pasadena consensus for the procedure assisted by robot.

Sponsors & Collaborators

• Rio de Janeiro State University

  lead OTHER

Principal Investigators

• Fabricio B Carrerette · State University of Rio de Janeiro

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-03-31

Primary Completion

2019-04-30

Completion

2019-04-30

Countries

• Brazil

Study Locations