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
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Cancer Prostatic Neoplasm||Procedure: 1 Retrograde radical prostatectomy RRP Procedure: 2 Anterograde radical prostatectomy RRP2A||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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
- PSA [ Time Frame: One year ]The rate of patients who have an undetectable PSA after surgery
- Time of urinary catheter [ Time Frame: Three months ]Time of catheter removal
- 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
- Hospital length of stay [ Time Frame: One month ]Measurement of hospital stay
- Positive surgical margins [ Time Frame: Three months ]The rate of patients who have an positive surgical margins
- 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.
- 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)
- 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.
- Postoperative complications [ Time Frame: One year ]Accurate reporting of postoperative complications such as bladder neck contractures
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
|State University of Rio de Janeiro|
|Rio de Janeiro, Brazil, 20551030|
|Principal Investigator:||Fabricio B Carrerette||State University of Rio de Janeiro|