Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy

January 25, 2022 updated by: Eralp Kubilay, Ankara University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Altındag
      • Ankara, Altındag, Turkey, 06850
        • Recruiting
        • Ankara University Faculty of Medicine Urology Department
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Retzius-repairing robot-assisted radical prostatectomy group
This group is randomized to operated with retzius-repairing technique as prostate cancer patients with robot assisted radical prostatectomy.
Procedure: Retzius-repairing robot-assisted radical prostatectomy
Repairing the retzius space which is opened during the standard robot assisted radical prostatectomy.
Other Names:
  • Retzius-sparing robot-assisted radical prostatectomy
Placebo Comparator: Retzius-sparing robot-assisted radical prostatectomy group
This group is randomized to operated with retzius-sparing technique as prostate cancer patients with robot assisted radical prostatectomy.
Procedure: Retzius-repairing robot-assisted radical prostatectomy
Repairing the retzius space which is opened during the standard robot assisted radical prostatectomy.
Other Names:
  • Retzius-sparing robot-assisted radical prostatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Outcomes-Urinary Incontinance 1st week
Time Frame: 1 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
Functional Outcomes-Urinary Incontinance 4th week
Time Frame: 4 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
Functional Outcomes-Urinary Incontinance 6th month
Time Frame: 6 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
Functional Outcomes-Urinary Incontinance 1st year
Time Frame: 1 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
Functional Outcomes-Erectile Dysfunction 4th week
Time Frame: 4 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
Functional Outcomes-Erectile Dysfunction 6th month
Time Frame: 6 month
For ERECTILE DYSFUNCTION; 6th month evaluation will be done with International Index of Erectile Function-5 questionaire.
6 month
Functional Outcomes-Erectile Dysfunction 1st year
Time Frame: 1 year

For ERECTILE DYSFUNCTION;

1st year evaluation will be done with International Index of Erectile Function-5 questionaire.
1 year
Oncological Outcomes
Time Frame: 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Principal Investigator: Eralp Kubilay, Ankara University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 15, 2022

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 25, 2022

First Posted (Actual)

February 4, 2022

Study Record Updates

Last Update Posted (Actual)

February 4, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANKUNI641991

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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