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

Last updated: December 8, 2024
Sponsor: Ministry of Science and Technology of the People´s Republic of China
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Standard Robot-Assisted Radical Prostatectomy

Laparoscopic Radical Prostatectomy

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

Clinical Study ID

NCT06730243
24/048-4328
  • Ages 18-80
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Insufficient knowledge of German Severe cognitive impairment Obesity (BMI > 35)Current existing severe comorbidities (e.g. liver cirrhosis, second malignancy orrelapse of every kind) Tumor stage: T4 Previous malignancy (≤ 3 years before trialparticipation) Neoadjuvant therapy (hormons) within the last 3 months beforeparticipation in the trial Patient is immuno-compromised History of intermittenturinary self-catheterization within the last year Psychological disorders (dementia,chronic depression, psychosis) Any of the following treatments ≤ 3 months beforetrial 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 patientsLacking willingness for data storage and handling in the frame of the trialprotocol/aims

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: Standard Robot-Assisted Radical Prostatectomy
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2025

Study 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.

Connect with a study center

  • National Cancer Center

    Beijing, Beijing 100021
    China

    Active - Recruiting

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