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Open Anterograde Radical Prostatectomy Compared to Open Retrograde Technique (RRP2A)

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ClinicalTrials.gov Identifier: NCT02687308
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : April 30, 2019
Sponsor:
Information provided by (Responsible Party):
Fabricio Borges Carrerette, Rio de Janeiro State University

Brief 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.

Condition or disease Intervention/treatment Phase
Prostatic Cancer Prostatic Neoplasm Procedure: 1 Retrograde radical prostatectomy RRP Procedure: 2 Anterograde radical prostatectomy RRP2A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Retropubic Radical Prostatectomy With Anterograde Anatomical Dissection Technique (RRP2A), Compared With Walsh Open Anatomical Retrograde Radical Prostatectomy (RRP)
Study Start Date : March 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1Retrograde radical prostatectomy RRP
This opem surgical prostatectomy techniques described by Patrick Walsh is made through prostatic dissection, from 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: 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
Other Name: Open retrograde radical retropubic prostatectomy (RRP)

Experimental: 2Anterograde radical prostatectomy RRP2A
This opem surgical prostatectomy techniques dissect the prostate, bladder neck and the neurovascular bundle, in an antegrade way, from bladder neck to the apex. With careful bladder neck dissection and preservation, careful nervesparing procedures with meticulous retroprostatic dissection of the posterior layer of Denonvilliers' fascia, and urethrovesical anastomosis performed through a monofilament running 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.
Other Name: Open anterograde radical retropubic prostatectomy (RRP2A)




Primary Outcome Measures :
  1. Surgical time for completed prostatectomy [ Time Frame: Day of surgery ]
    Measurement of time for completed surgery. The median operative duration will be measured in minutes and compared between the two techniques


Secondary Outcome Measures :
  1. PSA [ Time Frame: One year ]
    The rate of patients who have an undetectable PSA after surgery

  2. Time of urinary catheter [ Time Frame: Three months ]
    Time of catheter removal

  3. Time of urethrovesical anastomosis [ Time Frame: Day of surgery ]
    Time to accomplish urethrovesical anastomosis. The median duration of urethrovesical anastomosis will be measured in minutes and compared between the two techniques

  4. Hospital length of stay [ Time Frame: One month ]
    Measurement of hospital stay

  5. Positive surgical margins [ Time Frame: Three months ]
    The rate of patients who have an positive surgical margins

  6. Urinary Continence [ Time Frame: One year ]
    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.

  7. Erectile function [ Time Frame: One year ]
    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)

  8. Surgical complication [ Time Frame: Three months postsurgery ]
    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.

  9. Postoperative complications [ Time Frame: One year ]
    Accurate reporting of postoperative complications such as bladder neck contractures



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40 years or older and willing and able to provide informed consent;
  2. Histologically and clinically confirmed localized adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell, or small cell features;
  3. Surgical indication for open radical prostatectomy;
  4. PSA less than 20 ng/mL;
  5. No evidence of metastasis disease;
  6. Cleared by the primary medical doctor for surgery;
  7. No prior systemic therapy for prostate cancer;
  8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

  1. Refuses to give informed consent;
  2. Refuses or is unable to have radical prostatectomy;
  3. Stage T4;
  4. Deemed a poor surgical risk per primary medical doctor;
  5. Received prior therapeutic intervention for prostate cancer;
  6. Deep vein thrombosis (DVT)/pulmonary embolism (PE) in the past 6 months;
  7. Neurogenic bladder;
  8. Urinary incontinence.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687308


Locations
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Brazil
State University of Rio de Janeiro
Rio de Janeiro, Brazil, 20551030
Sponsors and Collaborators
Rio de Janeiro State University
Investigators
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Principal Investigator: Fabricio B Carrerette State University of Rio de Janeiro
Publications of Results:

Other Publications:
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Responsible Party: Fabricio Borges Carrerette, Professor, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT02687308    
Other Study ID Numbers: 41908815.9.0000.5259
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: through a table without identifying the name but with the initial and the registration number in the institution
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: The study will be alowed when statistical analyses data and results are completed after article is published and estimated time for one year.
Access Criteria: Men diagnosed with localized prostatic cancer and indication of radical prostatectomy. Exclusion criteria: clinical contra indications for surgery, local advanced prostate cancer and PSA marker up to 20 ng/dL.
Keywords provided by Fabricio Borges Carrerette, Rio de Janeiro State University:
Prostatic cancer
Radical prostatectomy
Minimally invasive prostate cancer surgery
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases