Retzius-sparing Technique in Robotic-assisted Radical Prostatectomy

NCT05224024 | Unknown DMC FDA Device

• 1 other identifier: ANKUNI641991
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Prostate; Prostate Adenocarcinoma; Urinary Incontinence,Stress; Erectile Dysfunction Following Radical Prostatectomy

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Retzius-repairing robot-assisted radical prostatectomy group

ACTIVE COMPARATOR

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

Retzius-sparing robot-assisted radical prostatectomy group

PLACEBO COMPARATOR

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

Interventions

Retzius-repairing robot-assisted radical prostatectomy PROCEDURE

Repairing the retzius space which is opened during the standard robot assisted radical prostatectomy.

Also known as: Retzius-sparing robot-assisted radical prostatectomy

Retzius-repairing robot-assisted radical prostatectomy group; Retzius-sparing robot-assisted radical prostatectomy group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pre-existing urinary incontinence,
• Any previous prostatic, urethral, bladder neck surgery,
• Neoadjuvant therapy.

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University Faculty of Medicine Urology Department

Ankara, Altındag, 06850, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 20566236 RESULT

• 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.

  PMID: 23856036 RESULT

• 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.

  PMID: 29595042 RESULT

• 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.

  PMID: 19171418 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eralp Kubilay

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eralp Kubilay

CONTACT

+905310231323; eralpkubi@gmail.com

Cagri Akpinar

CONTACT

+905417387638; akpinar.cagri89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: February 4, 2022
• Study Start: February 15, 2022
• Primary Completion: August 30, 2022
• Study Completion: December 31, 2022
• Last Updated: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)