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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02687308
Other study ID # 41908815.9.0000.5259
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date April 2019

Study information

Verified date April 2019
Source Rio de Janeiro State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

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
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.

Locations

Country Name City State
Brazil State University of Rio de Janeiro Rio de Janeiro

Sponsors (1)

Lead Sponsor Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

References & Publications (30)

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Outcome

Type Measure Description Time frame Safety issue
Primary Surgical time for completed prostatectomy Measurement of time for completed surgery. The median operative duration will be measured in minutes and compared between the two techniques Day of surgery
Secondary PSA The rate of patients who have an undetectable PSA after surgery One year
Secondary Time of urinary catheter Time of catheter removal Three months
Secondary Time of urethrovesical anastomosis Time to accomplish urethrovesical anastomosis. The median duration of urethrovesical anastomosis will be measured in minutes and compared between the two techniques Day of surgery
Secondary Hospital length of stay Measurement of hospital stay One month
Secondary Positive surgical margins The rate of patients who have an positive surgical margins Three months
Secondary Urinary Continence The rate of patients who have complete recovery of urinary continence. At the time of catheter removal all patients who have a dry safety pad within the first 24 h will be define as continent. Urinary continence will be evaluate using the International Consultation of Incontinence Questionnaire of Urinary Incontinence (ICIQ-UI) short-form instrument. One year
Secondary Erectile function The rate of patients who have complete recovery of erectile function. Erectile function will be evaluate using the International Index of Erectile Function (IIEF-5) One year
Secondary Surgical complication Accurate reporting based on the classification of Clavien-Dindo system such as lymphorrhea, lymphocele, bleeding, perioperative transfusion rate, pelvic hematoma, urine leakage and disrupted anastomosis. Three months postsurgery
Secondary Postoperative complications Accurate reporting of postoperative complications such as bladder neck contractures One year
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