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Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy

Primary Purpose

Cancer of Prostate, Prostate Adenocarcinoma, Urinary Incontinence,Stress

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Retzius-repairing robot-assisted radical prostatectomy
Sponsored by
Ankara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cancer of Prostate

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Ankara University Faculty of Medicine Urology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Retzius-repairing robot-assisted radical prostatectomy group

Retzius-sparing robot-assisted radical prostatectomy group

Arm Description

This group is randomized to operated with retzius-repairing technique as prostate cancer patients with robot assisted radical prostatectomy.

This group is randomized to operated with retzius-sparing technique as prostate cancer patients with robot assisted radical prostatectomy.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Functional Outcomes-Erectile Dysfunction 6th month
For ERECTILE DYSFUNCTION; 6th month evaluation will be done with International Index of Erectile Function-5 questionaire.
Functional Outcomes-Erectile Dysfunction 1st year
For ERECTILE DYSFUNCTION; 1st year evaluation will be done with International Index of Erectile Function-5 questionaire.
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.

Secondary Outcome Measures

Full Information

First Posted
December 21, 2021
Last Updated
January 25, 2022
Sponsor
Ankara University
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1. Study Identification

Unique Protocol Identification Number
NCT05224024
Brief Title
Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy
Official Title
Retzius-sparing Versus Retzius-repairing Robotic-assisted Radical Prostatectomy: A Prospective Randomized Comparison on Functional Outcomes With a 1-year Follow-up
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Anticipated)
Primary Completion Date
August 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Radical prostatectomy (RP) is the standard treatment method widely used in clinically localized and locally advanced prostate cancer (PCa). The main purpose of RP is to completely remove the tumor tissue and to provide the best oncological result and as well as recovery postoperative urinary continence and erectile functions. Depending on the severity of urinary leakage, incontinence is one of the important complications that seriously affect the quality of life after RP. Robot-assisted radical prostatectomy (RARP) has become a frequently preferred surgical treatment in PCa since the early 2000s. The effort to improve functional results has led to the continuous development and evolution of the robotic technique and different approaches have been tried to achieve the best. However, no sufficient evidence was found to show the superiority of any approach. In standard RARP, there may be a risk of deterioration of anatomical structures that contribute to the urinary continence (UC) mechanism due to the need for access to the retzius space. For this purpose, in 2010, Galfano et al. described a surgical technique performed through the douglas space in RP that preserves the retzius and the structures involved in the continence mechanism. With this technique, it is aimed to provide early recovery in UC and erectile functions after surgery by protecting the retzius. In the first case series of 200 patients, it was reported that an early UC was achieved in more than 90% of the patients. In addition, it was supported by other studies that early UC recovery rates are higher with the retzius-sparing (RS) technique, and in some series, immediate UC rates at the catheter removal were reported to be higher in the RS technique. However, it was stated that there was no significant difference in 1-year results between the standard technique and the RS technique. When the current literature is reviewed, the early continence advantages of the RS technique compared to the standard technique are emphasized. On the other hand, most surgeons still have not abandoned the standard technique, and a recent questionnaire of 250 participants showed that only 11% of RARP was performed using the RS-RALP approach. Although various continence preserving techniques have been tried in the standard RARP procedure, the high quality evidence for these techniques in the literature is limited. The focus of our study is lack of a randomized prospective study comparing the modified reconstructive anterior approach, which we define as retzius-repairing (RR), and the RS technique in the evaluation of postoperative functional outcomes. Differ from the current literature, we aim of this study is to evaluate the results of a single surgeon prospective randomized comparative study on functional outcomes at 1-year follow-up between RR-RALP and RS-RALP for clinically localized PCa treatment. This prospective randomized study has planned to carried out between June 2021 and December 2021, after achieving the ethics committee approval. Eligible patients were randomized in a 1:1 allocation ratio and 80 consecutive patients with clinically localized PCa underwent RALP by retzius-repairing (40 patients ) and retzius-sparing (40 patients) approach by a single surgeon (KT) and surgical team at a tertiary care institution (Ankara University School of Medicine), according to a parallel design. The assignment of each patient to the first or second treatment group was randomized with a computer-based randomization table. The UC recovery rates will be evaluated at the catheter removal, and subsequently at 1, 6 and 12 months after surgery. Postoperative potency will be eveluated at 3 and 12 months after surgeries. Other outcomes are the comparisons of postoperative complication rates, positive surgical margin and 1 year oncological outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Prostate, Prostate Adenocarcinoma, Urinary Incontinence,Stress, Erectile Dysfunction Following Radical Prostatectomy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retzius-repairing robot-assisted radical prostatectomy group
Arm Type
Active Comparator
Arm Description
This group is randomized to operated with retzius-repairing technique as prostate cancer patients with robot assisted radical prostatectomy.
Arm Title
Retzius-sparing robot-assisted radical prostatectomy group
Arm Type
Placebo Comparator
Arm Description
This group is randomized to operated with retzius-sparing technique as prostate cancer patients with robot assisted radical prostatectomy.
Intervention Type
Procedure
Intervention Name(s)
Retzius-repairing robot-assisted radical prostatectomy
Other Intervention Name(s)
Retzius-sparing robot-assisted radical prostatectomy
Intervention Description
Repairing the retzius space which is opened during the standard robot assisted radical prostatectomy.
Primary Outcome Measure Information:
Title
Functional Outcomes-Urinary Incontinance 1st week
Description
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.
Time Frame
1 week
Title
Functional Outcomes-Urinary Incontinance 4th week
Description
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.
Time Frame
4 week
Title
Functional Outcomes-Urinary Incontinance 6th month
Description
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.
Time Frame
6 month
Title
Functional Outcomes-Urinary Incontinance 1st year
Description
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.
Time Frame
1 year
Title
Functional Outcomes-Erectile Dysfunction 4th week
Description
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.
Time Frame
4 week
Title
Functional Outcomes-Erectile Dysfunction 6th month
Description
For ERECTILE DYSFUNCTION; 6th month evaluation will be done with International Index of Erectile Function-5 questionaire.
Time Frame
6 month
Title
Functional Outcomes-Erectile Dysfunction 1st year
Description
For ERECTILE DYSFUNCTION; 1st year evaluation will be done with International Index of Erectile Function-5 questionaire.
Time Frame
1 year
Title
Oncological Outcomes
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eralp Kubilay
Phone
+905310231323
Email
eralpkubi@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Cagri Akpinar
Phone
+905417387638
Email
akpinar.cagri89@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eralp Kubilay
Organizational Affiliation
Ankara University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ankara University Faculty of Medicine Urology Department
City
Ankara
State/Province
Altındag
ZIP/Postal Code
06850
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eralp Kubilay
Phone
05310231323
Email
eralpkubi@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20566236
Citation
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.2010.06.008. Epub 2010 Jun 16.
Results Reference
result
PubMed Identifier
23856036
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 the first 200 patients with >/= 1 year of follow-up. Eur Urol. 2013 Dec;64(6):974-80. doi: 10.1016/j.eururo.2013.06.046. Epub 2013 Jul 8.
Results Reference
result
PubMed Identifier
29595042
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 Nefrol. 2018 Aug;70(4):408-413. doi: 10.23736/S0393-2249.18.03069-2. Epub 2018 Mar 28.
Results Reference
result
PubMed Identifier
19171418
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.
Results Reference
result

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Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy

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