NCT06730243

Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction Versus Standard Robot-Assisted Radical Prostatectomy Versus Laparoscopic Radical Prostatectomy Surgery: A Comparative Prospective Study of 300 Patients

To Evaluate the Impact of Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction on Early Recovery of Urinary Continence (UC) Compared to the Conventional Approach (Anterior Approach) and Laparoscopic Radical Prostatectomy for the Treatment of Clinically Localized Prostate Cancer (PCa).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Ministry of Science and Technology of the People´s Republic of China · Other Government
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the impact of Retzius-sparing robot-assisted radical prostatectomy with "Sandwich" Technique of Total Urethral Reconstruction on early recovery of urinary continence (UC) compared to the conventional approach (anterior approach) and Laparoscopic Radical Prostatectomy for the treatment of clinically localized prostate cancer (PCa).Purpose: The trial compares outcomes between three groups.

Detailed description

300 consecutive patients with clinically localized PCa underwent RS-RARP-S (Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction) or S-RARP (Standard RARP) or LRP by 6 experienced surgeons regardless of clinicopathological features. The indication for one technique or the others were surgeon preference; one surgeon exclusively performed RS-RARP-S( did not exclude high risk cases or those with apical and anterior tumors), two surgeons performed S-RARP, and three surgeons exclusively performed LRP. The investigation include an extensive evaluation of clinical, oncological, functional and quality of life related data by means of validated patient-reported outcome measures. The primary outcome is early recovery of urinary continence compared to the conventional approach.

Conditions

• Retzius-sparing Robot-assisted Radical Prostatectomy With "Sandwich" Technique of Total Urethral Reconstruction

Interventions

Type	Name	Description
PROCEDURE	Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction	Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction
PROCEDURE	Standard Robot-Assisted Radical Prostatectomy	Standard Robot-Assisted Radical Prostatectomy
PROCEDURE	Laparoscopic Radical Prostatectomy	Laparoscopic Radical Prostatectomy

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-10
• Completion: 2025-01-01
• First posted: 2024-12-12
• Last updated: 2024-12-12

Locations

1 site across 1 country: China