Prostate Adenocarcinoma Clinical Trial
Official title:
Retzius-sparing Versus Retzius-repairing Robotic-assisted Radical Prostatectomy: A Prospective Randomized Comparison on Functional Outcomes With a 1-year Follow-up
The objective of this study is to compare the short-term and 1-yr follow-up functional outcomes of retzius-repairing robot-assisted radical prostatectomy (RR-RARP) with retzius-sparing (RS) RARP. This study is a single-centre, single-surgeon and a prospective randomized study.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 30, 2022 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Prostate cancer patients, - Life expectancy > 10 years, - Clinically organ confined disease (cT1-cT2), - Biopsy Gleason score = 7, - Total serum PSA = 10 ng/ml, - Normal preoperative continence and potency. Exclusion Criteria: - Pre-existing urinary incontinence, - Any previous prostatic, urethral, bladder neck surgery, - Neoadjuvant therapy. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara University Faculty of Medicine Urology Department | Ankara | Altindag |
Lead Sponsor | Collaborator |
---|---|
Ankara University |
Turkey,
Galfano A, Ascione A, Grimaldi S, Petralia G, Strada E, Bocciardi AM. A new anatomic approach for robot-assisted laparoscopic prostatectomy: a feasibility study for completely intrafascial surgery. Eur Urol. 2010 Sep;58(3):457-61. doi: 10.1016/j.eururo.20 — View Citation
Galfano A, Di Trapani D, Sozzi F, Strada E, Petralia G, Bramerio M, Ascione A, Gambacorta M, Bocciardi AM. Beyond the learning curve of the Retzius-sparing approach for robot-assisted laparoscopic radical prostatectomy: oncologic and functional results of — View Citation
Galfano A, Panarello D, Secco S, Di Trapani D, Barbieri M, Napoli G, Strada E, Petralia G, Bocciardi AM. Does prostate volume have an impact on the functional and oncological results of Retzius-sparing robot-assisted radical prostatectomy? Minerva Urol Ne — View Citation
van der Poel HG, de Blok W, Joshi N, van Muilekom E. Preservation of lateral prostatic fascia is associated with urine continence after robotic-assisted prostatectomy. Eur Urol. 2009 Apr;55(4):892-900. doi: 10.1016/j.eururo.2009.01.021. Epub 2009 Jan 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Outcomes-Urinary Incontinance 1st week | Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE;
1st week evaluation: The percentage of patients with Immediate urinary continence defined as 1 safety or no pad within 1 week of catheter removal will be compared. |
1 week | |
Primary | Functional Outcomes-Urinary Incontinance 4th week | Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 4th week evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire. | 4 week | |
Primary | Functional Outcomes-Urinary Incontinance 6th month | Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE; 6th month evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire. | 6 month | |
Primary | Functional Outcomes-Urinary Incontinance 1st year | Compare two surgical technique in terms of urinary incontinence. For URINARY INCONTINANCE;
1st year evaluation will be done with International Consultation on Urinary Incontinence on Male Lower Urinary Tract Symptoms questionaire. |
1 year | |
Primary | Functional Outcomes-Erectile Dysfunction 4th week | For ERECTILE DYSFUNCTION; 4th week evaluation: The percentage pf patient with Immediate potency defined as erections sufficient for intercourse within the first month after surgery will be compared. | 4 week | |
Primary | Functional Outcomes-Erectile Dysfunction 6th month | For ERECTILE DYSFUNCTION; 6th month evaluation will be done with International Index of Erectile Function-5 questionaire. | 6 month | |
Primary | Functional Outcomes-Erectile Dysfunction 1st year | For ERECTILE DYSFUNCTION;
1st year evaluation will be done with International Index of Erectile Function-5 questionaire. |
1 year | |
Primary | Oncological Outcomes | Comparison of surgical margin positivity from pathological reports between two surgery groups.
The percentage of partients with surgical margin positivity will be compared according to pathological investigation. |
1 year |
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