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 (RS-RARP-S)

Ministry of Science and Technology of the People´s Republic of China

Status: Enrolling

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

Treatments: Procedure: Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction; Procedure: Standard Robot-Assisted Radical Prostatectomy; Procedure: Laparoscopic Radical Prostatectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06730243

24/048-4328

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological verified prostate carcinoma (first diagnosis) Indication for primary curative radical prostatectomy Age ≤80 years Patient agrees to randomisation Patient is able to fill in the questionnaires on his own Patient is willing to provide written informed consent

Exclusion criteria

• Insufficient knowledge of German Severe cognitive impairment Obesity (BMI > 35) Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy or relapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trial participation) Neoadjuvant therapy (hormons) within the last 3 months before participation in the trial Patient is immuno-compromised History of intermittent urinary self-catheterization within the last year Psychological disorders (dementia, chronic depression, psychosis) Any of the following treatments ≤ 3 months before trial participation: surgery of the sigmoid colon, extended haemorrhoid resection, transurethral needle ablation of the prostate (TUNA), osteosynthesis of the pelvis, salvage prostatectomy Patients with chronic urinary infection Dialysis patients Lacking willingness for data storage and handling in the frame of the trial protocol/aims

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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300 participants in 3 patient groups

RS-RARP-S

Experimental group

Description:

Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction

Treatment:

Procedure: Retzius-sparing robot-assisted radical prostatectomy and "Sandwich" Technique of Total Urethral Reconstruction

S-RARP

Experimental group

Description:

Standard RARP

Treatment:

Procedure: Standard Robot-Assisted Radical Prostatectomy

LRP

Sham Comparator group

Description:

Laparoscopic Radical Prostatectomy

Treatment:

Procedure: Laparoscopic Radical Prostatectomy